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Sample records for suspected adverse reaction

  1. An Evaluation of Indian Consumers' Reporting of Suspected Adverse Drug Reactions with a Designated Reporting Form.

    Science.gov (United States)

    Rehan, Harmeet Singh; Sah, Ravinder; Gupta, Anubhuti; Nagar, Parvesh

    2017-01-01

    The Pharmacovigilance Program of India recently initiated a process for direct patient reporting of Adverse Drug Reactions (ADRs) with a designated form. A survey of 200 patients reporting ADRs filling the form. Forms were analysed for patient data, the suspected medication(s), ADRs and possible causality. 54.3% of respondents provided their contact information; the implicated medicine was mentioned in 60% and the description of ADRs in 80% although 46.2% were not interpretable. The severity of ADRs was mentioned in 73.5%. No responder filled the expiry date component of the implicated modification and a causality assessment from most forms was unclassifiable (57%) or unclassified (26%). Details of concomitant drugs were missing. Missing information was a deterrent in analysing the consumer ADR reports for signal detection. It is recommended that the following fields are highlighted in the form: consumer's initials, address, date suspected reaction started, description of event, name, dose, and the reason for the use the medication as well as its expiry date. These should be mandatory in the existing form and new fields added for weight and height, batch number for vaccines and biological products, de challenge and rechallenge results to the suspected medicine and concomitantly used medicines. To improve the quality of information in the consumer reporting form an awareness campaign is also suggested. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  2. Overview of suspected adverse reactions to veterinary medicinal products reported in South Africa (March 2002 – February 2003

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    V. Naidoo

    2003-07-01

    Full Text Available The Veterinary Pharmacovigilance and Medicines Information Centre is responsible for the monitoring of veterinary adverse drug reactions in South Africa. An overview of reports of suspected adverse drug reactions received by the centre during the period March 2002 to February 2003 is given. In total, 40 reports were received. This had declined from the previous year. Most reports involved suspected adverse reactions that occurred in dogs and cats. Most of the products implicated were Stock Remedies. The animal owner predominantly administered these products. Only 1 report was received from a veterinary pharmaceutical company. Increasing numbers of reports are being received from veterinarians.

  3. Enhancing communication about paediatric medicines: lessons from a qualitative study of parents' experiences of their child's suspected adverse drug reaction.

    Science.gov (United States)

    Arnott, Janine; Hesselgreaves, Hannah; Nunn, Anthony J; Peak, Matthew; Pirmohamed, Munir; Smyth, Rosalind L; Turner, Mark A; Young, Bridget

    2012-01-01

    There is little research on parents' experiences of suspected adverse drug reactions in their children and hence little evidence to guide clinicians when communicating with families about problems associated with medicines. To identify any unmet information and communication needs described by parents whose child had a suspected adverse drug reaction. Semi-structured qualitative interviews with parents of 44 children who had a suspected adverse drug reaction identified on hospital admission, during in-patient treatment or reported by parents using the Yellow Card Scheme (the UK system for collecting spontaneous reports of adverse drug reactions). Interviews were conducted face-to-face or by telephone; most interviews were audiorecorded and transcribed. Analysis was informed by the principles of the constant comparative method. Many parents described being dissatisfied with how clinicians communicated about adverse drug reactions and unclear about the implications for their child's future use of medicines. A few parents felt that clinicians had abandoned their child and reported refusing the use of further medicines because they feared a repeated adverse drug reaction. The accounts of parents of children with cancer were different. They emphasised their confidence in clinicians' management of adverse drug reactions and described how clinicians prospectively explained the risks associated with medicines. Parents linked symptoms to medicines in ways that resembled the established reasoning that clinicians use to evaluate the possibility that a medicine has caused an adverse drug reaction. Clinicians' communication about adverse drug reactions was poor from the perspective of parents, indicating that improvements are needed. The accounts of parents of children with cancer indicate that prospective explanation about adverse drug reactions at the time of prescription can be effective. Convergence between parents and clinicians in their reasoning for linking children

  4. Enhancing communication about paediatric medicines: lessons from a qualitative study of parents' experiences of their child's suspected adverse drug reaction.

    Directory of Open Access Journals (Sweden)

    Janine Arnott

    Full Text Available BACKGROUND: There is little research on parents' experiences of suspected adverse drug reactions in their children and hence little evidence to guide clinicians when communicating with families about problems associated with medicines. OBJECTIVE: To identify any unmet information and communication needs described by parents whose child had a suspected adverse drug reaction. METHODS: Semi-structured qualitative interviews with parents of 44 children who had a suspected adverse drug reaction identified on hospital admission, during in-patient treatment or reported by parents using the Yellow Card Scheme (the UK system for collecting spontaneous reports of adverse drug reactions. Interviews were conducted face-to-face or by telephone; most interviews were audiorecorded and transcribed. Analysis was informed by the principles of the constant comparative method. RESULTS: Many parents described being dissatisfied with how clinicians communicated about adverse drug reactions and unclear about the implications for their child's future use of medicines. A few parents felt that clinicians had abandoned their child and reported refusing the use of further medicines because they feared a repeated adverse drug reaction. The accounts of parents of children with cancer were different. They emphasised their confidence in clinicians' management of adverse drug reactions and described how clinicians prospectively explained the risks associated with medicines. Parents linked symptoms to medicines in ways that resembled the established reasoning that clinicians use to evaluate the possibility that a medicine has caused an adverse drug reaction. CONCLUSION: Clinicians' communication about adverse drug reactions was poor from the perspective of parents, indicating that improvements are needed. The accounts of parents of children with cancer indicate that prospective explanation about adverse drug reactions at the time of prescription can be effective. Convergence

  5. Herbal medicine use and linked suspected adverse drug reactions in a prospective cohort of Ugandan inpatients.

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    Kiguba, Ronald; Ononge, Sam; Karamagi, Charles; Bird, Sheila M

    2016-05-26

    Clinical history-taking can be employed as a standardized approach to elucidate the use of herbal medicines and their linked suspected adverse drug reactions (ADRs) among hospitalized patients. We sought to identify herbal medicines nominated by Ugandan inpatients; compare nomination rates by ward and gender; confirm the herbs' known pharmacological properties from published literature; and identify ADRs linked to pre-admission use of herbal medicines. Prospective cohort of consented adult inpatients designed to assess medication use and ADRs on one gynaecological and three medical wards of 1790-bed Mulago National Referral Hospital. Baseline and follow-up data were obtained on patients' characteristics, including pre-admission use of herbal medicines. Fourteen percent (26/191) of females in Gynaecology nominated at least one specific herbal medicine compared with 20 % (114/571) of inpatients on medical wards [20 % (69/343) of females; 20 % (45/228) of males]. Frequent nominations were Persea americana (30), Mumbwa/multiple-herb clay rods (23), Aloe barbadensis (22), Beta vulgaris (12), Vernonia amygdalina (11), Commelina africana (7), Bidens pilosa (7), Hoslundia opposita (6), Mangifera indica (4), and Dicliptera laxata (4). Four inpatients experienced 10 suspected ADRs linked to pre-admission herbal medicine use including Commelina africana (4), multiple-herb-mumbwa (1), or unspecified local-herbs (5): three ADR-cases were abortion-related and one kidney-related. The named herbal medicines and their nomination rates generally differed by specialized ward, probably guided by local folklore knowledge of their use. Clinical elicitation from inpatients can generate valuable safety data on herbal medicine use. However, larger routine studies might increase the utility of our method to assess herbal medicine use and detect herb-linked ADRs. Future studies should take testable samples of ADR-implicated herbal medicines for further analysis.

  6. [Suspected adverse reactions after vaccination. Results from the German Health Interview and Examination Survey for Children and Adolescents. Part 2: predictors of parental reporting of suspected adverse reactions after vaccinations].

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    Poethko-Müller, C; Atzpodien, K; Schmitz, R; Schlaud, M

    2011-03-01

    Each method to monitor vaccine safety has strengths and limitations. Therefore, vaccine safety monitoring should rely on different types of data sources. Methods commonly rely on patient-reported adverse reactions. Little is, however, known about factors that may affect the probability with which patients report adverse reactions to vaccines. From 2003-2006, the representative National Health Interview and Examination Survey for Children and Adolescents ("Kinder- und Jugendgesundheitssurvey", KiGGS) retrospectively collected information about vaccines, vaccination dates, and suspected vaccine related adverse reactions from a total of 17,641 participants (vaccinations were more likely reported from parents living in former West Germany compared to former East Germany (OR 1.61; 95% CI 1.08-2.39), parents of children with special health care needs (OR 1.49; 95% CI 1.08-2.04), and from parents reporting reservations against vaccinations (OR 3.29; 95% CI 2.28-4.75). Parental reporting of adverse vaccine reactions appears to be associated with parental perception and assessment of possible adverse vaccine reactions, as well as with the parents' attitude towards immunization in general.

  7. To study the pattern of suspected adverse drug reactions in patients coming to the department of dermatology in Gauhati Medical College and Hospital, Guwahati, Assam, India

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    Ajoy Borah; Mangala Lahkar; Binita Singha; Lihite, Ratan J.; Debeeka Hazarika

    2016-01-01

    Background: Cutaneous adverse drug reactions (ADRs) are the commonest ADRs (30-45%) and are responsible for about 2% of hospital admissions. This study was conducted to study the pattern of ADRs coming to the department of dermatology in a Tertiary Health Care Hospital. The objectives of the study were to assess the causality, severity, preventability, age distribution, sex distribution and the reactions occurring. Methods: Cross-sectional study. The suspected adverse drug reactions (ADRs)...

  8. Suspected adverse reactions to contrast media in Campania Region (Italy): results from 14 years of post-marketing surveillance.

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    Sessa, Maurizio; Rossi, Claudia; Mascolo, Annamaria; Grassi, Enrico; Fiorentino, Sonia; Scavone, Cristina; Reginelli, Alfonso; Rotondo, Antonio; Sportiello, Liberata

    2015-01-01

    During the last years in Italy, contrast media (CM) use increased. An increase of monitoring activities on CM-induced adverse drug reaction (ADR) is necessary, also in our regional territory. The main aim of this study was to give a preliminary evaluation of all Spontaneous Reports of ADRs (SRA) attributed to CM sent to Campania Pharmacovigilance Regional Center (CRFVC) from 01 January 2001 to 31 October 2014. For each SRA we evaluated: frequency and source, ADRs onset (time to event, seriousness and outcome), socio-demographic characteristics and risk factors of cases, the most reported CM (checking for pharmacodynamic and pharmacokinetic interactions). A total of 111 SRA were sent to CRFVC; specialist in radiology was the main source of reports. Ninety-seven SRA (87.3%) were referable to hypersensitivity reactions. Thirty-four SRA (30.6%) reported serious ADRs. The most reported CM were iopamidol, gadobenic acid and gadoteric acid. We identified two SRA induced by pharmacokinetic and/or pharmacodynamic interactions. During 14 years of post-marketing surveillance, only few SRA concerning CM-induced ADRs were sent to CRFVC probably due to underreporting. We aim to improve monitoring activity on CM-induced ADRs especially in hospitals. Most reported ADR and CM were in line with current body of literature.

  9. Filling quality of the reports of adverse drug reactions received at the Pharmacovigilance Centre of São Paulo (Brazil): missing information hinders the analysis of suspected associations.

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    Ribeiro, Adalton; Lima, Silvana; Zampieri, Maria-Elisa; Peinado, Mirtes; Figueras, Albert

    2017-12-01

    The completeness and accuracy of the reports of suspected adverse drug reactions is important in pharmacovigilance. The aim of the present study was to analyze the quality of the information included in the reports sent to the Pharmacovigilance Centre of São Paulo (Brazil). A sample of 999 reports received from January 2013 to December 2014 was selected. The quality of the filled information was evaluated according to a 'sufficiency' criterion to apply the Karch-Lasagna causality algorithm. There were 820 reports from manufacturers and 179 from health centres. Only 4.4% (44) were fully filled, thus allowing the adequate analysis of the causal relationship between the suspected medication and the adverse event. In 30% of the reports from manufacturers, the information about the critical variables was lacking or incomplete, preventing the adequate evaluation of the report. It was also noted that the reports' poor filling quality was not related with less severity or with old and well-known medicines. The poor quality of the information included in the reports received by this centre, especially those sent by pharmaceutical manufacturers, hampers the identification of potential safety signals. Measures to improve the quality of the reports must be urgently adopted.

  10. Adverse cutaneous drug reaction

    Directory of Open Access Journals (Sweden)

    Nayak Surajit

    2008-01-01

    Full Text Available In everyday clinical practice, almost all physicians come across many instances of suspected adverse cutaneous drug reactions (ACDR in different forms. Although such cutaneous reactions are common, comprehensive information regarding their incidence, severity and ultimate health effects are often not available as many cases go unreported. It is also a fact that in the present world, almost everyday a new drug enters market; therefore, a chance of a new drug reaction manifesting somewhere in some form in any corner of world is unknown or unreported. Although many a times, presentation is too trivial and benign, the early identification of the condition and identifying the culprit drug and omit it at earliest holds the keystone in management and prevention of a more severe drug rash. Therefore, not only the dermatologists, but all practicing physicians should be familiar with these conditions to diagnose them early and to be prepared to handle them adequately. However, we all know it is most challenging and practically difficult when patient is on multiple medicines because of myriad clinical symptoms, poorly understood multiple mechanisms of drug-host interaction, relative paucity of laboratory testing that is available for any definitive and confirmatory drug-specific testing. Therefore, in practice, the diagnosis of ACDR is purely based on clinical judgment. In this discussion, we will be primarily focusing on pathomechanism and approach to reach a diagnosis, which is the vital pillar to manage any case of ACDR.

  11. [Adverse reactions to insulin].

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    Liñana, J J; Montoro, F J; Hernández, M D; Basomba, A

    1997-07-01

    The prevalence of allergic reactions to insuline has decreased during the last few years. Probably this is due to the use of the newly-developed recombinant human insuline. At present, adverse reactions to insuline occur in 5-10% of patients on therapy with insuline. Adverse reactions may be local (more frequent) or systemic (rare). Insuline resistance consists in a different type of immunological reaction. Diagnosis of allergy to insuline is based on clinical history and cutaneous and serological tests. Treatment depends upon the severity of the reaction. When insuline is indispensable despite a previous allergic reaction, a desensitization protocol may be implemented.

  12. Adverse reaction to tetrazepam.

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    Palacios Benito, R; Domínguez Ortega, J; Alonso Llamazares, A; Rodríguez Morales, A; Plaza Díaz, A; Chamorro Gómez, M; Martínez-Cócera, C

    2001-01-01

    Adverse reactions caused by benzodiazepines rarely occur. We present a case of a 70-year-old man who developed a maculopapular exanthema after the ingestion of tetrazepam. For his diagnosis, skin tests were performed, including prick and patch tests, not only with the benzodiazepine implicated in the reaction, but also with benzodiazepines of other groups. Single-blind oral challenge tests were also performed in the patient, in order to assess his tolerance to other benzodiazepines.

  13. Adverse reactions to cosmetics

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    Dogra A

    2003-03-01

    Full Text Available Adverse reaction to cosmetics constitute a small but significant number of cases of contact dermatitis with varied appearances. These can present as contact allergic dermatitis, photodermatitis, contact irritant dermatitis, contact urticaria, hypopigmentation, hyperpigmentotion or depigmentation, hair and nail breakage. Fifty patients were included for the study to assess the role of commonly used cosmetics in causing adverse reactions. It was found that hair dyes, lipsticks and surprisingly shaving creams caused more reaction as compared to other cosmetics. Overall incidence of contact allergic dermatitis seen was 3.3% with patients own cosmetics. Patch testing was also done with the basic ingredients and showed positive results in few cases where casual link could be established. It is recommended that labeling of the cosmetics should be done to help the dermatologists and the patients to identify the causative allergen in cosmetic preparation.

  14. [Adverse reactions to vaccines].

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    Ito Tsuchiya, F M; Rosas Vargas, M A; Zepeda Ortega, B; Río del Navarro, Blanca Estela; Sienra Monge, Juan José Luis

    2007-01-01

    Vaccination is one of the medicine's achievements to control and/or eradicate certain infectious diseases. Vaccines contain antigenic doses derived from microorganisms and/or its toxins, besides they are composed of other substances such as aluminum, gelatin, egg proteins, mercury components (as thimerosal), and antibiotics; therefore, these substances can produce hypersensitivity reactions. The above-mentioned reactions can be evidenced with itch, edema, hives, asthmatic crisis, hypotension and even anaphylactic shock. Due to the importance of vaccination, especially in childhood, it is essential to know the benefits of vaccines, their impact in morbidity and mortality decrease of certain infected-contagious diseases, as well as the adverse effects and the allergic reactions to their application. As immunizations prevent natural infections, they might contribute to a free infectious environment that would allow atopic response. This paper reviews the allergic reactions to vaccines and their influence on the development of atopic disease.

  15. [Registration of suspected adverse effects by the Bureau Adverse Effects Drugs; research activities in 1993].

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    Stricker, B H; Ottervanger, J P; van der Klauw, M M

    1994-10-15

    In 1993, the Netherlands Centre for Monitoring of Adverse Reactions to Drugs received 1585 reports of suspected adverse reactions. The most important reports concerned myocardial infarction due to sumatriptan, cholestatic hepatitis due to itraconazole, agranulocytosis due to trazodone and bleeding due to fluoxetine and fluvoxamine. Other published reports concerned cholestatic hepatitis due to amoxicillin/clavulanic acid, hair loss due to beta-blockers, muscle necrosis due to diclofenac, bronchospasm, apnoea and cardiac arrest due to dipyridamole perfusion scintigraphy, interaction of fluvoxamine/fluoxetine and coumarins, liver enzyme elevations due to heparin, skin reactions due to Imedeen, deafness due to neomycin, addiction to nicotine chewing gum, atrial fibrillation and skin reactions due to nicotine patches, interaction between oral contraceptives and terbinafine, neonatal problems caused by psychopharmacological agents, parapemphigus caused by sulfasalazine, taste loss due to terbinafine en intracranial bleeding after use of tranylcypromine and beer. Pharmacoepidemiological studies were performed concerning methods for record linkage, the communication process with respect to the acitretin alert and the adverse events due to sumatriptan.

  16. Adverse Reactions to Hallucinogenic Drugs.

    Science.gov (United States)

    Meyer, Roger E. , Ed.

    This reports a conference of psychologists, psychiatrists, geneticists and others concerned with the biological and psychological effects of lysergic acid diethylamide and other hallucinogenic drugs. Clinical data are presented on adverse drug reactions. The difficulty of determining the causes of adverse reactions is discussed, as are different…

  17. Immunopharmacology and adverse drug reactions.

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    Rieder, M J

    1993-04-01

    Adverse drug reactions are common and troublesome complications of contemporary pharmacotherapy. Adverse drug reactions are frequently, and often incorrectly, referred to as "allergy". Although there are multiple mechanisms for adverse drug reactions, adverse drug reactions mediated by the immune system account for a disproportionate number of fatal and serious adverse reactions, and constitute a major clinical problem for patients and physicians. The immune system has evolved in multicellular organisms as a defence against infection. Interactions between drugs and the immune system occur as inadvertent consequences of the protective function of the immune system, with drug molecules or drug-carrier haptens being recognized as "non-self" by the immune system. The classical mechanisms for drug hypersensitivity described by Gell and Coombs (Types 1 to 4) include IgE-mediated, cytotoxic, immune complex-mediated and delayed mechanism. These mechanisms provide elegant models for drug-immune interactions that can provide mechanistic explanations for events such as urticaria associated with penicillins. However, these mechanisms do not account for many of the immunologically mediated adverse reactions commonly encountered in clinical practice. Over the last two decades, there has been an increasing awareness of the importance of reactive drug metabolites and drug-protein interactions in the initiation of immunologic events mediating adverse drug reactions. Reactive drug metabolites may produce direct and profound effects on various functions of the immune system. Although some adverse reactions mediated by the immune system occur with equal frequency among adults and children, some of these reactions appear to be markedly more common among children than adults.(ABSTRACT TRUNCATED AT 250 WORDS)

  18. Biomarkers of adverse drug reactions.

    Science.gov (United States)

    Carr, Daniel F; Pirmohamed, Munir

    2017-01-01

    Adverse drug reactions can be caused by a wide range of therapeutics. Adverse drug reactions affect many bodily organ systems and vary widely in severity. Milder adverse drug reactions often resolve quickly following withdrawal of the casual drug or sometimes after dose reduction. Some adverse drug reactions are severe and lead to significant organ/tissue injury which can be fatal. Adverse drug reactions also represent a financial burden to both healthcare providers and the pharmaceutical industry. Thus, a number of stakeholders would benefit from development of new, robust biomarkers for the prediction, diagnosis, and prognostication of adverse drug reactions. There has been significant recent progress in identifying predictive genomic biomarkers with the potential to be used in clinical settings to reduce the burden of adverse drug reactions. These have included biomarkers that can be used to alter drug dose (for example, Thiopurine methyltransferase (TPMT) and azathioprine dose) and drug choice. The latter have in particular included human leukocyte antigen (HLA) biomarkers which identify susceptibility to immune-mediated injuries to major organs such as skin, liver, and bone marrow from a variety of drugs. This review covers both the current state of the art with regard to genomic adverse drug reaction biomarkers. We also review circulating biomarkers that have the potential to be used for both diagnosis and prognosis, and have the added advantage of providing mechanistic information. In the future, we will not be relying on single biomarkers (genomic/non-genomic), but on multiple biomarker panels, integrated through the application of different omics technologies, which will provide information on predisposition, early diagnosis, prognosis, and mechanisms. Impact statement • Genetic and circulating biomarkers present significant opportunities to personalize patient therapy to minimize the risk of adverse drug reactions. ADRs are a significant heath issue

  19. Adverse Reactions to Biologic Therapy.

    Science.gov (United States)

    Patel, Sheenal V; Khan, David A

    2017-05-01

    Biologic therapies are emerging as a significant therapeutic option for many with debilitating inflammatory and autoimmune conditions. As expansion in the number of FDA-approved agents continue to be seen, more unanticipated adverse reactions are likely to occur. Currently, the diagnostic tools, including skin testing and in vitro testing, to evaluate for immediate hypersensitivity reactions are insufficient. In this review, management strategies for common acute infusion reactions, injection site reactions, and immediate reactions suggestive of IgE-mediated mechanisms are discussed. Desensitization can be considered for reactions suggestive of IgE-mediated mechanisms, but allergists/immunologists should be involved in managing these patients. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. Differences between Drug-Induced and Contrast Media-Induced Adverse Reactions Based on Spontaneously Reported Adverse Drug Reactions.

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    Ryu, JiHyeon; Lee, HeeYoung; Suh, JinUk; Yang, MyungSuk; Kang, WonKu; Kim, EunYoung

    2015-01-01

    We analyzed differences between spontaneously reported drug-induced (not including contrast media) and contrast media-induced adverse reactions. Adverse drug reactions reported by an in-hospital pharmacovigilance center (St. Mary's teaching hospital, Daejeon, Korea) from 2010-2012 were classified as drug-induced or contrast media-induced. Clinical patterns, frequency, causality, severity, Schumock and Thornton's preventability, and type A/B reactions were recorded. The trends among causality tools measuring drug and contrast-induced adverse reactions were analyzed. Of 1,335 reports, 636 drug-induced and contrast media-induced adverse reactions were identified. The prevalence of spontaneously reported adverse drug reaction-related admissions revealed a suspected adverse drug reaction-reporting rate of 20.9/100,000 (inpatient, 0.021%) and 3.9/100,000 (outpatients, 0.004%). The most common adverse drug reaction-associated drug classes included nervous system agents and anti-infectives. Dermatological and gastrointestinal adverse drug reactions were most frequently and similarly reported between drug and contrast media-induced adverse reactions. Compared to contrast media-induced adverse reactions, drug-induced adverse reactions were milder, more likely to be preventable (9.8% vs. 1.1%, p contrast media-induced adverse reactions (56.6%, p = 0.066). Causality patterns differed between the two adverse reaction classes. The World Health Organization-Uppsala Monitoring Centre causality evaluation and Naranjo algorithm results significantly differed from those of the Korean algorithm version II (p contrast media-induced adverse reactions. The World Health Organization-Uppsala Monitoring Centre and Naranjo algorithm causality evaluation afforded similar results.

  1. Cutaneous Adverse Reactions of Amiodarone

    Science.gov (United States)

    Jaworski, Krzysztof; Walecka, Irena; Rudnicka, Lidia; Gnatowski, Maciej; Kosior, Dariusz A.

    2014-01-01

    Dermatological complications of amiodarone are commonly encountered problems in therapy. The incidence in the population of patients with prolonged use of amiodarone reaches nearly 75% according to various sources. Nevertheless, they are often misdiagnosed or overlooked. The aim of this review is to present the current state of knowledge about skin changes induced by amiodarone, including phototoxic and photoallergic reactions, as well as hyperpigmentation. In most cases, the adverse effects are reversible and disappear after discontinuation of the drug. Although the dermatological complications usually do not influence the outcome of the therapy and rarely cause discontinuation of treatment, they have a great impact on patient quality of life. PMID:25413691

  2. ADVERSE DRUG REACTION (ADR) MONITORING AND PHARMACOVIGILANCE

    OpenAIRE

    D. KAVITHA

    2013-01-01

    The need for systematic follow up of medicines for adverse drug reactions once they are introduced into general use has been widely recognised today. Even in developing countries like India, national pharmacovigilance programme has been started for monitoring adverse drug reactions. In its first year this program mainly aimed to foster the culture of ADR notification among health care professionals. As a part of health care team every pharmacist must have knowledge about adverse drug reaction...

  3. [Nursing role in reporting adverse drug reactions].

    Science.gov (United States)

    Zurita-Garaicoechea, Ana; Reis-Carvalho, Joana; Ripa-Aisa, Irantzu; Jiménez-Mendoza, Ana; Díaz-Balén, Almudena; Oroviogoicoechea, Cristina

    2015-01-01

    The spontaneous report system, in which suspected adverse drug reaction (ADR) are reported by healthcare workers, is currently one of the primary methods to prevent and discover new and serious ADR to marketed medicinal products. The collaboration of nursing professionals with this task makes it possible to improve patient safety and to reduce ADR costs. Although a total of 781 cases of ADR cases were reported in Navarra in 2011, only 7.33% were reported by nurses. The objectives werw to determine the factors that influence nurses in reporting of ADR, and second, to devise strategies which help to increase reporting. A bibliographic search for articles that included the words: reacciones adversas medicamentosas (adverse drug reactions), notificación (reporting) and enfermería (nursing) was conducted using the PubMed and Cinhal databases. A total of 107 articles were retrieved, of which 27 were selected according to inclusion and exclusion criteria. The conclusion learned by reading and analyzing the selected articles was that the factors that affect the notification depend on the attitude of the notifier, as well as personal and professional factors. The main strategies to encourage notification are education and training, motivation, and the availability of facilitating tools. The main factors that have an influence on under-notification are the lack of knowledge and motivation among professionals. To solve the problem of under-notification, the main actions and strategies to undertake are education, motivation and persistence. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

  4. [Adverse reactions to iodinated contrast media].

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    Galimany-Masclans, Jordi; Garrido-Aguilar, Eva; Pernas-Canadell, Juan Carlos; Díaz-Rodríguez, Susana

    2010-01-01

    The aim of the study is to determine the incidence of adverse reactions to iodinated contrast media and to characterise them in a group of outpatients, inpatients and emergency patients in a private hospital in Barcelona. A retrospective cohort study was carried out over a 60 months period, from February 2002 to February 2007, analysing the patients who underwent to iodinated contrast radiological examinations. Adverse reactions were evaluated from the manual record format developed following the requirements of the Quality Assurance Program in Radiology. Study variables were, administration route, contrast media dose, adverse reaction type, and signs and symptoms. Statistical analysis was descriptive. A total of 68 (0.3 %) of adverse reaction were registered of which 64 were mild (94.1%), 4 moderate (5.9%) and none severe. On the basis of the administration route (intravenous or oral) adverse reaction were 67 (94%) and 1 (6%) respectively. With a 40-80ml contrast media dose by injection, mild adverse reactions were 87.5%, moderate 12.5% and severe 0%. With a 90-150ml contrast media dose by injection, mild adverse reaction were 94.9% and moderate 5.1%. The number of adverse reaction using iodinated contrast media is low and are they are generally mild; however the nurse must be ready to recognise and treat them. Copyright © 2010 Elsevier España, S.L. All rights reserved.

  5. Reversal of a Suspected Paradoxical Reaction to Zopiclone with Flumazenil

    DEFF Research Database (Denmark)

    Jordahn, Zarah; Andersen, Cheme; Aaberg, Anne Marie Roust

    2016-01-01

    ), the patient became agitated and was confused, a possible paradoxical reaction to benzodiazepines. These symptoms were immediately resolved after treatment with flumazenil, usually used to reverse the adverse effects of benzodiazepines or NBRAs and to reverse paradoxical reactions to benzodiazepines. This case...... indicates that zopiclone induced behavioral changes resembling a paradoxical reaction to benzodiazepines and these symptoms may be treated with flumazenil....

  6. Mechanisms underlying adverse reactions to vaccines.

    Science.gov (United States)

    Siegrist, C-A

    2007-07-01

    A broad spectrum of adverse events is reported following human vaccination but such reactions are considered to be relatively rare. A variety of mechanisms has been proposed to account for such adverse events. These most commonly relate to the actual process of vaccination and range from the vagal reaction associated with anxiety about needle injection, to use of an inappropriate site of administration, or infection of the healthcare worker by accidental injection during needle-capping. Other adverse events directly associated with the vaccine include reversion to virulence of attenuated vaccine strains of organisms, or contamination of the vaccine product. Adverse events may involve immune-mediated phenomena triggered by exposure to the microbial or other components of vaccines. These include: classical IgE-mediated type I hypersensitivity reactions, and immune-complex type III hypersensitivity (Arthus) reactions. Such reactions may be localized or systemic in nature. A variety of autoimmune reactions has been suggested to be triggered by vaccination, but in general the evidence for such associations remains largely anecdotal. Finally, many reported adverse events are simply chance instances of infection or disease onset around the time of vaccination and are not causally associated with administration of vaccine.

  7. Snake antivenoms: adverse reactions and production technology

    Directory of Open Access Journals (Sweden)

    VM Morais

    2009-01-01

    Full Text Available Antivenoms have been widely used for more than a century for treating snakebites and other accidents with poisonous animals. Despite their efficacy, the use of heterologous antivenoms involves the possibility of adverse reactions due to activation of the immune system. In this paper, alternatives for antivenom production already in use were evaluated in light of their ability to minimize the occurrence of adverse reactions. These effects were classified according to their molecular mechanism as: anaphylactic reactions mediated by IgE, anaphylactoid reactions caused by complement system activation, and pyrogenic reactions produced mainly by the presence of endotoxins in the final product. In the future, antivenoms may be replaced by humanized antibodies, specific neutralizing compounds or vaccination. Meanwhile, improvements in antivenom quality will be focused on the obtainment of a more purified and specific product in compliance with good manufacturing practices and at an affordable cost.

  8. Analysis of pediatric adverse reactions to transfusions.

    Science.gov (United States)

    Vossoughi, Sarah; Perez, Gabriela; Whitaker, Barbee I; Fung, Mark K; Stotler, Brie

    2018-01-01

    Children are known to be physiologically and biochemically different from adults. However, there are no multi-institutional studies examining the differences in the frequency, type, and severity of transfusion reactions in pediatric versus adult patients. This study aims to characterize differences between pediatric and adult patients regarding adverse responses to transfusions. This is a retrospective data analysis of nine children's hospitals and 35 adult hospitals from January 2009 through December 2015. Included were pediatric and adult patients who had a reported reaction to transfusion of any blood component. Rates are reported as per 100,000 transfusions for comparison between pediatric and adult patients. Pediatric patients had an overall higher reaction rate compared to adults: 538 versus 252 per 100,000 transfusions, notably higher for red blood cell (577 vs. 278 per 100,000; p reactions, febrile nonhemolytic reactions, and acute hemolytic reactions were observed in pediatric patients. Adults had a higher rate of delayed serologic transfusion reactions, delayed hemolytic transfusion reactions, and transfusion-associated circulatory overload. Pediatric patients had double the rate of transfusion reactions compared to adults. The nationally reported data on reaction rates are consistent with this study's findings in adults but much lower than the observed rates for pediatric patients. Future studies are needed to address the differences in reaction rates, particularly in allergic and febrile reactions, and to further address blood transfusion practices in the pediatric patient population. © 2017 AABB.

  9. Global patterns of adverse drug reactions over a decade

    DEFF Research Database (Denmark)

    Aagaard, Lise; Strandell, Johanna; Melskens, Lars

    2012-01-01

    Background: Although systems to collect information about suspected adverse drug reactions (ADRs) were established in many countries and by the WHO in the 1960s, few studies have examined reported ADRs related to national income. Objective: The aim of the study was to characterize ADRs reported...... use' and 'antineoplastic and immunomodulation agents'. To strengthen ADR reporting rates, especially in low-income countries, more research is needed about the impact of organizational structures and economic resources of national pharmacovigilance centres and ADR reporting practices on the large...

  10. Epidemiology of adverse drug reactions in Europe

    DEFF Research Database (Denmark)

    Bouvy, Jacoline C; De Bruin, Marie L; Koopmanschap, Marc A

    2015-01-01

    Adverse drug reactions (ADRs) cause considerable mortality and morbidity but no recent reviews are currently available for the European region. Therefore, we performed a review of all epidemiological studies quantifying ADRs in a European setting that were published between 1 January 2000 and 3...... regarding the epidemiology of ADRs in this setting....

  11. Adverse reactions to injectable soft tissue fillers

    DEFF Research Database (Denmark)

    Requena, Luis; Requena, Celia; Christensen, Lise

    2011-01-01

    In recent years, injections with filler agents are often used for wrinkle-treatment and soft tissue augmentation by dermatologists and plastic surgeons. Unfortunately, the ideal filler has not yet been discovered and all of them may induce adverse reactions. Quickly biodegradable or resorbable ag...

  12. Reversal of a Suspected Paradoxical Reaction to Zopiclone with Flumazenil

    Directory of Open Access Journals (Sweden)

    Zarah Jordahn

    2016-01-01

    Full Text Available We describe the care for an elderly woman who was admitted to the intensive care unit (ICU to receive noninvasive ventilation for acute exacerbation of chronic obstructive pulmonary disease. After administration of the sleeping pill zopiclone, a nonbenzodiazepine receptor agonist (NBRA, the patient became agitated and was confused, a possible paradoxical reaction to benzodiazepines. These symptoms were immediately resolved after treatment with flumazenil, usually used to reverse the adverse effects of benzodiazepines or NBRAs and to reverse paradoxical reactions to benzodiazepines. This case indicates that zopiclone induced behavioral changes resembling a paradoxical reaction to benzodiazepines and these symptoms may be treated with flumazenil.

  13. 21 CFR 606.170 - Adverse reaction file.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Adverse reaction file. 606.170 Section 606.170... Adverse reaction file. (a) Records shall be maintained of any reports of complaints of adverse reactions... thorough investigation of each reported adverse reaction shall be made. A written report of the...

  14. Pharmacogenomics and Adverse Drug Reactions in Children

    Directory of Open Access Journals (Sweden)

    Michael John Rieder

    2014-04-01

    Full Text Available Adverse drug reactions are a common and important complication of drug therapy in children. Over the past decade it has become increasingly apparent that genetically controlled variations in drug disposition and response are important determinants of adverse events for many important adverse events associated with drug therapy in children. While this research has been difficult to conduct over the past decade technical and ethical evolution has greatly facilitated the ability of investigators to conduct pharmacogenomic studies in children. Some of this research has already resulted in changes in public policy and clinical practice, for example in the case of codeine use by mothers and children. It is likely that the use of pharmacogenomics to enhance drug safety will first be realized among selected groups of children with high rates of drug use such as children with cancer, but it also likely that this research will be extended to other groups of children who have high rates of drug utilization and as well as providing insights into the mechanisms and pathophysiology of adverse drug reactions in children.

  15. An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions

    DEFF Research Database (Denmark)

    Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne

    2017-01-01

    INTRODUCTION: Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region...... of Denmark. The ADEM assists healthcare professionals in reporting suspected ADRs to the Danish Health Authority. The aim of this retrospective observational study was to quantify and describe ADRs reported via the ADEM in 2014. METHODS: All ADR reports handled by the ADEM in 2014 were recorded anonymously...... reporting and helps raise awareness about ADRs, including how and why they should be reported. Hopefully, this will assist national and European spontaneous reporting systems in their work to increase patient safety nationally and abroad. FUNDING: none. TRIAL REGISTRATION: not relevant. ....

  16. An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions

    DEFF Research Database (Denmark)

    Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne

    2017-01-01

    INTRODUCTION: Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region...... of Denmark. The ADEM assists healthcare professionals in reporting suspected ADRs to the Danish Health Authority. The aim of this retrospective observational study was to quantify and describe ADRs reported via the ADEM in 2014. METHODS: All ADR reports handled by the ADEM in 2014 were recorded anonymously...... and analysed descriptively. RESULTS: A total of 484 ADRs were reported through the ADEM in 2014 (the median number of reports per month was 37; range: 17-78). The majority of the reports came from departments of internal medicine (61%), psychiatry (14%) and dermatology, ophthalmology or otorhinolaryngology (11...

  17. Adverse food reactions in dogs and cats.

    Science.gov (United States)

    Gaschen, Frédéric P; Merchant, Sandra R

    2011-03-01

    Adverse food reactions (AFR) are a common problem that may cause cutaneous and/or gastrointestinal signs in dogs and cats. They comprise food intolerance, food intoxication, and food allergy. Response to a dietary elimination trial and recurrence of signs during dietary provocation remain the centerpiece of diagnosis and management of dogs and cats with AFR. Response to an elimination trial is frequently observed in dogs and cats with chronic idiopathic enteropathies. However, only a fraction of them relapse after a dietary challenge. These animals may have mild to enteritis and/or colitis and benefit from various additional properties of the elimination diet. Copyright © 2011 Elsevier Inc. All rights reserved.

  18. [Adverse reactions to food in daycare children].

    Science.gov (United States)

    Madrigal, B I; Alfaro, A N; Jiménez, C C; González, G J

    1996-01-01

    A prospective descriptive survey was applied to 291 children of three different nurseries in Guadalajara, México. Medical history was done to the suspicious ones, from those, only 11 were positive (3.78%). The presumptive diagnosis of food allergy was based on the patient's history, food challenges and food elimination. The most frequent age of presentation was at 2 (34.7%) and at 4 (34.7%) years old. The food reactions were: lactose intolerance (1.7%), allergy to eggs (0.6%), carrots (0.3%), food additives (0.6%), sausages and ham (0.3%), gettina a prevalence of adverse reaction of 3.7% to food in this population. The ablactation began before three months of age in all the children with allergenic meals like: citrics (43.3%) and eggs (13%). The clinical manifestations found were diarrhea, vomiting, abdominal pain, abdominal distense, flatulence palpebral edema of nose, cheeks and hands.

  19. Treatments for Severe Cutaneous Adverse Reactions

    Directory of Open Access Journals (Sweden)

    Yung-Tsu Cho

    2017-01-01

    Full Text Available Severe cutaneous adverse reaction (SCAR is life-threatening. It consists of Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN, drug reaction with eosinophilia and systemic symptoms (DRESS, acute generalized exanthematous pustulosis (AGEP, and generalized bullous fixed drug eruptions (GBFDE. In the past years, emerging studies have provided better understandings regarding the pathogenesis of these diseases. These diseases have unique presentations and distinct pathomechanisms. Therefore, theoretically, the options of treatments might be different among various SCARs. However, due to the rarity of these diseases, sufficient evidence is still lacking to support the best choice of treatment for patients with SCAR. Herein, we will provide a concise review with an emphasis on the characteristics and treatments of each SCAR. It may serve as a guidance based on the current best of knowledge and may shed light on the directions for further investigations.

  20. Treatments for Severe Cutaneous Adverse Reactions

    Science.gov (United States)

    Cho, Yung-Tsu

    2017-01-01

    Severe cutaneous adverse reaction (SCAR) is life-threatening. It consists of Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and generalized bullous fixed drug eruptions (GBFDE). In the past years, emerging studies have provided better understandings regarding the pathogenesis of these diseases. These diseases have unique presentations and distinct pathomechanisms. Therefore, theoretically, the options of treatments might be different among various SCARs. However, due to the rarity of these diseases, sufficient evidence is still lacking to support the best choice of treatment for patients with SCAR. Herein, we will provide a concise review with an emphasis on the characteristics and treatments of each SCAR. It may serve as a guidance based on the current best of knowledge and may shed light on the directions for further investigations. PMID:29445753

  1. Reported adverse drug reactions during the use of inhaled steroids in children with asthma in the Netherlands

    NARCIS (Netherlands)

    de Vries, T.W.; de Langen-Wouterse, J J; van Puijenbroek, E; Duiverman, E J; de Jong-Van den Berg, L T W

    Objective: Inhaled corticosteroids (ICS) are widely used in the treatment of asthma. We studied the suspected adverse drug reactions (sADRs) reported during the use of ICS in the Netherlands. Methods: In the Netherlands, health professionals and patients can report suspected ADRs to the

  2. Prevalence of adverse drug reactions in adult patients on anti ...

    African Journals Online (AJOL)

    Results: Systematic random sampling was used to pick 350 patients' files. There were 219 recorded adverse drug reactions in 170 (48.6%) patients (some patients had more than one adverse drug reaction). Peripheral neuropathy was the most common adverse drug reaction with a prevalence of 28.9% followed by lipid ...

  3. Adverse Drug Reaction Monitoring in Ethiopia: Analysis of case ...

    African Journals Online (AJOL)

    Bernt Lindtjørn

    Abstract. Background: Ensuring the health and safety of the public from adverse reaction of drugs is paramount. Adverse. Drug Reactions Monitoring (ADRM) is a system that is put in place to ensure the health and safety of the public from adverse reactions of drugs. It heavily relies on health professionals (HPs) reporting of ...

  4. Percentage of patients with preventable adverse drug reactions and preventability of adverse drug reactions--a meta-analysis

    National Research Council Canada - National Science Library

    Hakkarainen, Katja M; Hedna, Khadidja; Petzold, Max; Hägg, Staffan

    2012-01-01

    Numerous observational studies suggest that preventable adverse drug reactions are a significant burden in healthcare, but no meta-analysis using a standardised definition for adverse drug reactions exists...

  5. Consumer reporting of adverse drug reactions

    DEFF Research Database (Denmark)

    Aagaard, Lise; Nielsen, Lars Hougaard; Hansen, Ebba Holme

    2009-01-01

    BACKGROUND: Reporting adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals. Since 2003 in Denmark, consumers have been able to report ADRs directly to the authorities. The objective of this study was to compare ADRs reported by consumers with ADRs...... medicines on level 1 of the anatomical therapeutic chemical (ATC) classification system. ADR reports from consumers were compared with reports from other sources (physicians, pharmacists, lawyers, pharmaceutical companies and other healthcare professionals). Chi-square and odds ratios (ORs) were calculated...... to investigate the dependence between type of reporter and reported ADRs (classified by ATC or SOC). FINDINGS: We analysed 6319 ADR reports corresponding to 15 531 ADRs. Consumers reported 11% of the ADRs. Consumers' share of 'serious' ADRs was comparable to that of physicians (approximately 45%) but lower than...

  6. Ranking Adverse Drug Reactions With Crowdsourcing

    KAUST Repository

    Gottlieb, Assaf

    2015-03-23

    Background: There is no publicly available resource that provides the relative severity of adverse drug reactions (ADRs). Such a resource would be useful for several applications, including assessment of the risks and benefits of drugs and improvement of patient-centered care. It could also be used to triage predictions of drug adverse events. Objective: The intent of the study was to rank ADRs according to severity. Methods: We used Internet-based crowdsourcing to rank ADRs according to severity. We assigned 126,512 pairwise comparisons of ADRs to 2589 Amazon Mechanical Turk workers and used these comparisons to rank order 2929 ADRs. Results: There is good correlation (rho=.53) between the mortality rates associated with ADRs and their rank. Our ranking highlights severe drug-ADR predictions, such as cardiovascular ADRs for raloxifene and celecoxib. It also triages genes associated with severe ADRs such as epidermal growth-factor receptor (EGFR), associated with glioblastoma multiforme, and SCN1A, associated with epilepsy. Conclusions: ADR ranking lays a first stepping stone in personalized drug risk assessment. Ranking of ADRs using crowdsourcing may have useful clinical and financial implications, and should be further investigated in the context of health care decision making.

  7. Ranking adverse drug reactions with crowdsourcing.

    Science.gov (United States)

    Gottlieb, Assaf; Hoehndorf, Robert; Dumontier, Michel; Altman, Russ B

    2015-03-23

    There is no publicly available resource that provides the relative severity of adverse drug reactions (ADRs). Such a resource would be useful for several applications, including assessment of the risks and benefits of drugs and improvement of patient-centered care. It could also be used to triage predictions of drug adverse events. The intent of the study was to rank ADRs according to severity. We used Internet-based crowdsourcing to rank ADRs according to severity. We assigned 126,512 pairwise comparisons of ADRs to 2589 Amazon Mechanical Turk workers and used these comparisons to rank order 2929 ADRs. There is good correlation (rho=.53) between the mortality rates associated with ADRs and their rank. Our ranking highlights severe drug-ADR predictions, such as cardiovascular ADRs for raloxifene and celecoxib. It also triages genes associated with severe ADRs such as epidermal growth-factor receptor (EGFR), associated with glioblastoma multiforme, and SCN1A, associated with epilepsy. ADR ranking lays a first stepping stone in personalized drug risk assessment. Ranking of ADRs using crowdsourcing may have useful clinical and financial implications, and should be further investigated in the context of health care decision making.

  8. Cutaneous adverse drug reactions seen at a university hospital department of dermatology

    DEFF Research Database (Denmark)

    Borch, Jakob E; Andersen, Klaus E; Bindslev-Jensen, Carsten

    2006-01-01

    Patients with suspected cutaneous adverse drug reactions are often referred to allergy clinics or departments of dermatology for evaluation. These patients are selected compared with patients identified in prospective and cross-sectional studies of hospital populations. This explains the observed...... variation in prevalence of specific reactions and of eliciting drugs. This study investigated the prevalence of cutaneous adverse drug reactions in a university hospital department of dermatology that is specially focused on allergy. An 8-month survey was carried out during the period April-December 2003...

  9. [Pharmacotherapy of hyperthyreosis--adverse drug reactions].

    Science.gov (United States)

    Perger, Ludwig; Bürgi, Ulrich; Fattinger, Karin

    2011-06-01

    The antithyroid drugs mainly include thioimidazole (carbimazole, methimazole=thiamazole) and propylthiouracil. After absorption, carbimazole is rapidly metabolized to methimazole and thus switching between these two drugs should not be considered in case of side effects. Furthermore, in case of side effects, sometimes even cross reactions between thioimidazoles and propylthiouracil occur. Common and typical adverse reactions of antithyroid drugs include dose dependent hypothyroidism and thus thyroid function should be repeatedly checked while the patient is on antithyroid drugs. Furthermore, pruritus and rash may develop. In this case, one might try to switch from thioimidazoles to propylthiouracil or vice versa. Antithyroid drugs may cause mild dose dependent neutropenia or severe allergy-mediated agranulocytosis, which typically occurs during the first three months of treatment, has an incidence of 3 per 10,000 patients and cross reactivity between thioimidazoles to propylthiouracil may occur. Rarely, antithyroid drugs can cause aplastic anemia. Mainly propylthiouracil, but sometimes also methimazole may lead to an asymptomatic transient increase in liver enzymes or to severe, even lethal liver injury of cholestatic or hepatocellular pattern. Since propylthiouracil associated liver injury was observed increasingly among children and adolescent, it has been suggested to prefer thioimidazoles for these patients. Because of these potential serious adverse effects, physicians should advise patients to immediately seek medical help if they get a fever or sore throat or malaise, abdominal complaints or jaundice, respectively. Furthermore, arthralgias may develop in 1-5% of patients under both antithyroid drugs. Since arthralgias may be the first symptom of more serious immunologic side effects, it is recommended to stop the antithyroid drug in this case. Drug induced polyarthritis mainly develops during the first month of therapy, whereas ANCA-positive vasculitis is

  10. Adverse reactions during treatment with amiodarone hydrochloride.

    Science.gov (United States)

    McGovern, B; Garan, H; Kelly, E; Ruskin, J N

    1983-01-01

    Amiodarone was administered to 80 patients with recurrent cardiac tachyarrhythmias previously resistant to drug treatment. Forty nine patients were treated for ventricular tachycardia or fibrillation and 31 for supra-ventricular arrhythmias. The mean (range six days to 51 months), permitting a total of 100 patient years of observation. Adverse reactions were observed in 69 patients. Severe side effects were encountered in 13: four patients developed interstitial pneumonitis, four patients developed incessant ventricular tachycardia, three patients taking amiodarone and digoxin sustained sinus node arrest with depression of escape foci, one patient developed hepatitis, and one patient developed hypercalcaemia with renal failure. Furthermore, a rise in the serum concentration of digoxin and potentiation of warfarin anticoagulation occurred in cases in which these agents were combined with amiodarone. Amiodarone was stopped in 14 patients because of side effects. Although amiodarone is effective in suppressing arrhythmias in most patients in whom extensive use of antiarrhythmic drugs has been unsuccessful, it is associated with diverse and serious toxicity. These observations suggest that at present the use of amiodarone should be reserved for patients with life threatening or seriously disabling arrhythmias in whom longer established drugs have been ineffective or are contraindicated. Images FIG 1 FIG 2 PMID:6409240

  11. Longitudinal growth assessment for the prediction of adverse perinatal outcome in SGA-suspected fetuses.

    Science.gov (United States)

    Caradeux, Javier; Eixarch, Elisenda; Mazarico, Edurne; Basuki, Tri Rahmat; Gratacos, Eduard; Figueras, Francesc

    2017-08-07

    Fetal growth restriction (FGR) is associated with an increased risk of adverse perinatal outcome (APO). However, distinguishing this condition from smallness-for-gestational age remains elusive. A set of criteria has recently been proposed for such purpose, including the severity of smallness, Doppler parameters and growth velocity. To establish whether the use of growth velocity adds to Doppler evaluation in predicting APO among SGA-suspected fetuses. A prospective cohort of consecutive singleton pregnancies with late (diagnosis > 32.0 weeks) SGA (estimated fetal weight [EFW] SGA. Of them, 231 (48.9%) qualified as late FGR. Univariate analysis showed a significant trend towards higher frequency of EFW z-velocity in the lowest decile in pregnancies with APO (14.5% vs. 8.2%; p = 0.041). Nonetheless, the addition of z-velocity neither improved the association nor the prediction performance of standard criteria of FGR for the occurrence of APO. Longitudinal assessment of fetal growth by means of z-velocity did not have any independent predictive value for adverse perinatal outcome when used in combination with Doppler in SGA-suspected fetuses. This article is protected by copyright. All rights reserved.

  12. An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions.

    Science.gov (United States)

    Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne; Darsø, Perle; Christophersen, Anette Kvindebjerg; Borck, Bille; Christensen, Catrine; Hansen, Melissa Voigt; Halladin, Natalie Monica Løvland; Christensen, Mikkel Bring; Harboe, Kirstine Moll; Lund, Marie; Jimenez-Solem, Espen

    2017-01-01

    Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region of Denmark. The ADEM assists healthcare professionals in reporting suspected ADRs to the Danish Health Authority. The aim of this retrospective observational study was to quantify and describe ADRs reported via the ADEM in 2014. All ADR reports handled by the ADEM in 2014 were recorded anonymously and analysed descriptively. A total of 484 ADRs were reported through the ADEM in 2014 (the median number of reports per month was 37; range: 17-78). The majority of the reports came from departments of internal medicine (61%), psychiatry (14%) and dermatology, ophthalmology or otorhinolaryngology (11%). The drugs most frequently reported were lisdexamphetamine (n = 40), rivaroxaban (n = 16) and warfarin (n = 15) (vaccines excluded). In 13 out of 484 reports, the ADR was associated with a fatal outcome. The findings of this study indicate that an ADEM promotes and facilitates spontaneous ADR reporting and helps raise awareness about ADRs, including how and why they should be reported. Hopefully, this will assist national and European spontaneous reporting systems in their work to increase patient safety nationally and abroad. none. not relevant. .

  13. [Histamine intolerance - are the criteria of an adverse reaction met?].

    Science.gov (United States)

    Reese, Imke

    2016-06-01

    Searching the internet for an explaination of recurring symptoms, many people come across the so-called histamine intolerance disorder. Also many practitioners like to diagnose this disorder without making sure that reproducibility, a prerequisite for an adverse reaction, is present. Consequently, presumably affected persons are often advised to follow a low-histamine diet. Depending on the source of information, these diets often avoid a huge variety of foods containing more or less histamine, which has a considerable impact on patient quality of life. While most persons benefit from such a diet in the beginning - this might be due to the change in dietary habits or the expectation of symptom improvement by dieting - in the long run the expected loss of symptoms will not happen. Underlying a diminished capacity for histamine degradation, the lack of partial or complete symptom improvement might be due to the fact that endogenous histamine release is responsible for reactions. The role of ingested histamine is discussed controversially. However, it is more than obvious that the histamine content of a certain food alone is not enough to predict its tolerance.If histamine intolerance is suspected, an individual diagnostic and therapeutic procedure is mandatory in order to minimize avoidance and to preserve a high quality of life. Ideally this is done in a close cooperation between allergologists and nutritionists/dieticians.

  14. The German Haemovigilance System--reports of serious adverse transfusion reactions between 1997 and 2007.

    Science.gov (United States)

    Keller-Stanislawski, B; Lohmann, A; Günay, S; Heiden, M; Funk, M B

    2009-12-01

    Data of the German Haemovigilance System were collected from 1997 to 2007 and assessed on the basis of pre-defined safety standards. Suspected cases of serious adverse reactions following transfusions reported to the Paul-Ehrlich-Institut were evaluated on the basis of national criteria, and the definitions of International Society of Blood Transfusion (ISBT) in compliance with defined causality criteria. The suspected cases were rated as confirmed and unconfirmed transfusion reactions. Assessment of causality took into consideration the clinical course of the adverse reaction and, if necessary, information about donation and manufacturing. Of the 5128 suspected serious adverse reactions, 1603 could be confirmed. Referring to the absolute figures, acute transfusion reactions (e.g. allergic reactions, hypotension and dyspnoea) were recorded most frequently, followed by transfusion-related acute lung injury (TRALI), haemolytic reactions, transfusion-related bacterial infections and virus infections. The majority of the 52 transfusion-related fatalities (14 each) were due to TRALI and acute transfusion reactions (mostly severe allergic reactions). Referred to the blood products administered, immune TRALI cases and TRALI-related fatal courses were most frequently reported after administration of fresh frozen plasma (FFP) (15/10(6) and 3.5/10(6) units, respectively), transfusion-related bacterial infections after administration of platelet concentrates (7/10(6) units), acute haemolytic transfusion reactions after administration of red blood cell concentrates (2.3/10(6)units) and acute transfusion reactions after administration of red blood cell or platelet concentrates (7.8/10(6) and 13/10(6) units, respectively). Despite the high safety standard required for blood products in Germany, there is still room for reducing the frequency of isolated cases of transfusion reactions by targeted action.

  15. [Analysis on the concepts related to adverse events and adverse reactions of acupuncture].

    Science.gov (United States)

    Wang, Chuan; Liu, Baoyan; Liu, Yan; He, Liyun; Li, Hongjiao; Liu, Jia

    2018-01-12

    With the increasing popularity of acupuncture therapy in the world, the safety of acupuncture has attracted more attention. The objective and impartial assessment of the safety of acupuncture becomes very important. The "adverse events of acupuncture" and "adverse reactions of acupuncture" are the common concepts in the research of acupuncture safety. In the paper, on the basis of the conceptual characteristics of "adverse events" and "adverse reactions" and in combination with the particular characteristics of acupuncture itself, the connation and features of the concepts of the "adverse events of acupuncture" and "adverse reactions of acupuncture" are analyzed. The interaction and differences are summarized. Both "adverse events of acupuncture" and "adverse reactions of acupuncture" are in the category of adverse medical events. The "adverse events of acupuncture" includes the damages induced by acupuncture therapy and also those without relationship with acupuncture therapy. The "adverse reactions of acupuncture" refers to the adverse outcomes induced by acupuncture therapy specially. It has the definite relationship with acupuncture therapy. Hence, the application of "adverse reactions of acupuncture" is more objective and accurate in the assessment of acupuncture safety.

  16. Delayed adverse reactions to blood donation.

    Science.gov (United States)

    Kamel, Hany; Tomasulo, Peter; Bravo, Marjorie; Wiltbank, Thomas; Cusick, Robin; James, Robert C; Custer, Brian

    2010-03-01

    Blood donation is safe, but a small proportion of donors have delayed and/or off-site reactions that have the potential to lead to serious injury. This retrospective study sought to identify risk factors for delayed reactions (DRs). The records of 793,293 allogeneic whole blood and apheresis donations in 2007 were assessed for vasovagal reactions. Donor demographic, biometric, and clinical measurements were captured. Incidents related to needle insertion and mild reactions were excluded. Based on the reaction onset time relative to the procedure end time, reactions were classified as delayed (>15 min) or immediate (Reactions were analyzed by multivariable logistic regression comparing donors with immediate reactions (IRs) or DRs to donors without reactions and comparing donors with DRs to IRs. The clinical consequences of off-site and on-site reactions are reported. The prevalence of reactions classified as moderate or severe was 41 in 10,000 donations; 24% of these reactions were delayed and 12% occurred off-site. DRs were associated with female sex (odds ratio [OR], 2.96; 95% confidence interval [CI], 2.21-3.96) and with low estimated blood volume (EBV; OR, 3.91; 96% CI, 2.84-5.51). Off-site reactions, particularly in female donors, were more likely to be associated with a fall, with head trauma, with other injury, and with the use of outside medical care. Low EBV, youth, and first-time donor status are major risk factors for IRs and DRs. Women are more likely than men to report DRs. Delayed and off-site reactions lead to potentially preventable morbidity. Understanding the physiologic basis of DRs may lead to the development of appropriate interventions to reduce their likelihood.

  17. Prevalence of adverse drug reactions in adult patients on anti ...

    African Journals Online (AJOL)

    Background: There has been an increased access to anti-retrovirals in resourceconstrained settings. However, few studies have addressed the area of adverse drug reactions in these settings. Objective: To determine the prevalence of adverse drugs reactions in HIV-infected persons receiving anti-retrovirals. Design: A ...

  18. Attitude and Practice of Doctors Toward Adverse Drug Reactions ...

    African Journals Online (AJOL)

    Background : Adverse drug reactions, (ADRs), constitute an important cause of morbidity and mortality worldwide. Spontaneous adverse drug reaction (ADR) reporting is the bedrock of post-marketing surveillance but under-reporting remains its major drawback. Objectives : This study aimed at evaluating the attitude and ...

  19. Occurrence of adverse drug reactions in patients taking tenofovir ...

    African Journals Online (AJOL)

    Background: Tenofovir, lamivudine and efavirenz is the recommended first-line treatment for HIV in resource-limited countries. However, tenofovir and efavirenz have significant adverse reactions, which have not been adequately studied in Zimbabwe. Aim: To determine the extent of occurrence of adverse drug reactions in ...

  20. Risk factors, management and outcomes of adverse drug reactions ...

    African Journals Online (AJOL)

    Background: Antiretrovirals have been associated with serious adverse drug reactions. Several factors have been suggested as independent risk factors for their development. Identification of these factors may help in prevention and management of the adverse drug reactions. Objective: To describe the factors associated ...

  1. Assessment of adverse reactions to latex gloves use among nurses ...

    African Journals Online (AJOL)

    Adverse reaction to latex is a common problem among nurses and other health care workers. The aim of the present study was to determine the prevalence of adverse reactions to latex amongst nurses at Mankweng Hospital. A cross sectional study was carried out amongst 235 nurses at Mankweng Hospital using a ...

  2. Unity from diversity: the evidential use of anecdotal reports of adverse drug reactions and interactions.

    Science.gov (United States)

    Aronson, Jeffrey K

    2005-04-01

    Anecdotal case reports contribute about one-third of the published literature on adverse drug reactions and interactions, but are regarded as providing poor-quality evidence. However, they can occasionally provide proof of cause and effect, and there are many other reasons for publishing them. Because an anecdote is a narrative, narratological paradigms from literature, art, and music can show how we can make evidential use of anecdotes. Useful paradigms are the dramatic unities (of time, place, and action), comprehensive catalogues, and pattern formations. Here I give examples of each of these types of paradigm and show how they can be used to interpret anecdotes about adverse drug reactions and interactions. The dramatic unities show how a proper classification of adverse drug reactions can be achieved, according to dose-relation, time-course, and susceptibility factors; use of this classification should improve the evidential use of anecdotal reports. A high background incidence of the effect (the medical equivalent of subplots, which violate the unity of action) makes it more difficult to detect adverse drug effects using anecdotal reports. To make best evidential use of the corpus of anecdotal reports of adverse drug reactions, comprehensiveness is important: each suspected adverse reaction should be reported in detail and reactions should be reported in sufficient numbers for proper classification and for patterns to be recognized. One form of pattern recognition, teleoanalysis of data, should, when possible, include not only randomized controlled trials and observational studies, but also case series and anecdotal reports.

  3. Managing nonteratogenic adverse reactions to isotretinoin treatment for acne vulgaris.

    Science.gov (United States)

    Reilly, Bridget K; Ritsema, Tamara S

    2015-07-01

    Isotretinoin is the strongest, most effective oral treatment for patients with severe acne vulgaris, with remission rates of 89% and higher. Because of its potency, isotretinoin causes many adverse reactions. This article reviews common and severe adverse reactions to isotretinoin and how providers can best manage these reactions. Because of inconclusive research on the correlation between isotretinoin and depression and irritable bowel syndrome, providers should ask patients about symptoms monthly. Prescribing micronized isotretinoin and starting at the lowest dose with gradual upward titration also can help reduce the incidence of adverse reactions.

  4. Adverse reactions to contrast media: an analysis from spontaneous reporting data.

    Science.gov (United States)

    Cutroneo, Paola; Polimeni, Giovanni; Curcuruto, Roberto; Calapai, Gioacchino; Caputi, Achille P

    2007-07-01

    Diagnostic contrast media (CM) are a widely used class of drugs with poor information regarding their safety. Nevertheless, epidemiological studies showed that CM cause adverse reactions commonly considered unpreventable and unavoidable. Because spontaneous reporting is a valuable methodology for better defining the safety profile of drugs after their approval, we analyzed the spontaneous reports of suspected adverse reactions attributed to CM sent to the Sicilian Regional Centre for the Spontaneous Reporting of Adverse Drug Reactions (ADRs) during the period from 1996 to 2006, with the aim to identify their most important features. One hundred ADR reports out of 3471 involved CM (2.9%); 29 reports were serious, including 1 fatal case. Skin, respiratory system and gastrointestinal tract were most frequently affected sites. The majority of reports described hypersensitivity reactions with immediate onset. Iopromide (52.5%), iopamidol (13.9%) and iomeprol (11.9%) were the drugs with the highest number of reports. Case reports collected by the Sicilian Regional Centre showed that CM adverse reactions are not common or not commonly signalled; however, in agreement with previous published reports, analysis of data suggests that they are generally allergic-like reactions. Further investigations are needed within post-marketing surveillance to identify and prevent the consequences of CM adverse reactions and interactions. Awareness about CM safety should be promoted among all healthcare professionals.

  5. Antiretroviral adverse drug reactions and their management

    African Journals Online (AJOL)

    2011-06-02

    Jun 2, 2011 ... This article discusses the common and serious adverse effects (AEs) related to the above antiretrovirals and the steps to take to avoid and ... first programmes to deliver antiretroviral therapy in South Africa. Her particular interests are in HIV pharmacology, adherence to ART and long-term retention in care.

  6. Promoting adverse drug reaction reporting: comparison of different approaches

    Directory of Open Access Journals (Sweden)

    Inês Ribeiro-Vaz

    2016-01-01

    Full Text Available ABSTRACT OBJECTIVE To describe different approaches to promote adverse drug reaction reporting among health care professionals, determining their cost-effectiveness. METHODS We analyzed and compared several approaches taken by the Northern Pharmacovigilance Centre (Portugal to promote adverse drug reaction reporting. Approaches were compared regarding the number and relevance of adverse drug reaction reports obtained and costs involved. Costs by report were estimated by adding the initial costs and the running costs of each intervention. These costs were divided by the number of reports obtained with each intervention, to assess its cost-effectiveness. RESULTS All the approaches seem to have increased the number of adverse drug reaction reports. We noted the biggest increase with protocols (321 reports, costing 1.96 € each, followed by first educational approach (265 reports, 20.31 €/report and by the hyperlink approach (136 reports, 15.59 €/report. Regarding the severity of adverse drug reactions, protocols were the most efficient approach, costing 2.29 €/report, followed by hyperlinks (30.28 €/report, having no running costs. Concerning unexpected adverse drug reactions, the best result was obtained with protocols (5.12 €/report, followed by first educational approach (38.79 €/report. CONCLUSIONS We recommend implementing protocols in other pharmacovigilance centers. They seem to be the most efficient intervention, allowing receiving adverse drug reactions reports at lower costs. The increase applied not only to the total number of reports, but also to the severity, unexpectedness and high degree of causality attributed to the adverse drug reactions. Still, hyperlinks have the advantage of not involving running costs, showing the second best performance in cost per adverse drug reactions report.

  7. Antiretroviral adverse drug reactions and their management

    African Journals Online (AJOL)

    2011-06-02

    Jun 2, 2011 ... and nausea. Lamivudine (3TC) and. Lipodystrophic changes emtricitabine (FTC). Zidovudine (AZT). Anaemia, leuco- or neutropenia. Skin or nail pigmentation, nausea, myalgia, change in taste. Abacavir (ABC). Drug hypersensitivity reaction. Headache, loss of appetite, nausea, diarrhoea. Stavudine(d4T).

  8. The Senegal pertussis trial: safety and surveillance of adverse reactions.

    Science.gov (United States)

    Preziosi, M P; Ndiaye, M; Coll-Seck, A; Simondon, F

    1997-01-01

    In the Senegal pertussis trial, common adverse reactions were actively monitored during the pilot phase II study, while the frequency of severe adverse reactions was monitored as a secondary objective within the phase III efficacy trial. Since the trial was conducted in Niakhar, an area in rural West Africa under intensive surveillance, the safety monitoring during the study was incorporated within the general surveillance system. This was a two-step procedure: detection of a potential reaction by a field worker, followed by confirmation report by a physician. The frequency of severe reactions was low among both pertussis vaccine groups, receiving either the two-component acellular vaccine or the whole-cell vaccine currently used in the Senegal Expanded Programme on immunisation. Among severe reactions, only persistent crying was found to be at a significantly higher rate in the whole-cell group. Common adverse reactions were more frequent in the whole-cell group.

  9. Severe Adverse Drug Reaction to Gadobenate Dimeglumine

    Directory of Open Access Journals (Sweden)

    Benjamin D. Singer

    2009-01-01

    Full Text Available A 57-year-old man was admitted to our hospital for evaluation and management of stroke in the setting of an atrial septal defect. Shortly after receiving gadobenate dimeglumine for magnetic resonance imaging of the pelvic vessels, he experienced cardiac arrest from which he was resuscitated. His course was complicated by profound distributive shock. The presumed cause was a severe anaphylactic or anaphylactoid reaction to the gadolinium-based compound that he received.

  10. Adverse reactions of biological therapies in patients with psoriasis

    Directory of Open Access Journals (Sweden)

    Maria I. Sârbu

    2017-04-01

    Full Text Available Psoriasis is a chronic, immune-mediated disorder characterized by well demarcated, erythematous plaques covered by thick, silvery-white scales, most often located on the knees, elbows, sacral area and scalp. It has a significant impact on the patient's quality of life. Biological therapies revolutionized the treatment of psoriasis vulgaris but there has been concern regarding the use of those agents due to severe adverse reactions reported in patients receiving TNF-α inhibitors for various inflammatory diseases. The aim of this paper is to review the most important adverse reactions reported in patients receiving biological treatments. The most common and severe side effects associated with biologicals are infections, cardiac adverse reactions, neurologic adverse reactions, lymphomas, non-melanoma skin cancers and hepatobiliary disease.

  11. Adverse drug reactions of Intermittent chemotherapy compared to ...

    African Journals Online (AJOL)

    Adverse drug reactions of Intermittent chemotherapy compared to daily regimen in Sudanese patients with pulmonary Tuberculosis. MSM Salih, IB Eltayeb, AM Zaki, B Eldein, H Idriss, AEH Ahmed, HMM Eldein ...

  12. Management of acute adverse reactions to contrast media.

    Science.gov (United States)

    Thomsen, Henrik S; Morcos, Sameh K

    2004-03-01

    When anaphylactoid and other severe adverse reactions to contrast media occur, prompt recognition and immediate treatment are essential. Simple guidelines for treatment have been requested by many radiologists, and therefore the Contrast Media Safety Committee has produced guidelines for treatment of acute adverse reactions to contrast media. The committee made an extensive review of the literature on treatment of adverse reactions to contrast media. Based on this, a report and guidelines were prepared. The resulting report was discussed at the 10th European Symposium on Urogenital Radiology in Uppsala. Sweden, September 2003. Guidelines for treatment of acute adverse reactions and a list of first-line drugs and equipment that should be available in the room where contrast medium is given are provided.

  13. Adverse reaction to veterinary multivitamins and vitamin B complex ...

    African Journals Online (AJOL)

    It has been reported that dogs in South-western Nigeria react adversely to injectable veterinary multivitamins and human vitamin B complex preparations. Experimentation and interview survey were concurrently conducted to identify the type of Adverse Drug Reactions (ADRs) that the indications produced. For the survey ...

  14. Adverse reactions in voluntary whole blood donors: Experience at ...

    African Journals Online (AJOL)

    Background: Whole blood donation, generally considered as a safe procedure, may be sometimes associated with adverse reactions and injuries of variable severity during or after the blood donation process. There are few reports of adverse events related to blood donation in the Democratic Republic of Congo.

  15. Adverse drug reactions among HIV infected and uninfected adults ...

    African Journals Online (AJOL)

    Background: Information about the prevalence of adverse drug reactions (ADRs) among HIV infected and HIV uninfected patients receiving anti-tuberculous therapy in Africa is limited due to unavailability of local data or publications and hence the basis of this study. Objective: To determine the prevalence of adverse drug ...

  16. Adverse reactions in whole blood donors: an Indian scenario.

    Science.gov (United States)

    Pathak, Chintamani; Pujani, Meenu; Pahuja, Sangeeta; Jain, Manjula

    2011-01-01

    Whole blood donation is generally considered to be a safe procedure, but occasionally adverse reactions of varying severity may occur during or at the end of the collection. The aim of the study was to estimate the frequency and type of adverse events occurring during blood donation and to assess the practices which would help to minimise them. This retrospective single-centre study was conducted from June 2007 to November 2009 at a regional blood transfusion centre. All whole blood donations made at the centre were analysed. All adverse events occurring during or at the end of donation were noted using a standardised format. Overall 113 adverse events were reported in relation to 19,045 donations, resulting in an overall adverse event rate of 0.6%, that is, an incidence of 1 in every 166 donations. Presyncopal symptoms, in other words vasovagal reactions of mild intensity, were the most commonly observed adverse reactions and accounted for approximately 70% of all adverse reactions noted. Only 0.6% of blood donations were complicated by adverse events and most of these events were presyncopal symptoms. Our study reinforces the fact that blood donation is a very safe procedure which could be made even more event-free by following certain friendly, reassuring and tactful practices.

  17. Status survey on the adverse reactions of CT contrast media

    Energy Technology Data Exchange (ETDEWEB)

    Moon, Il Bong; Dong, Kyung Rae [Dept. of Radiological Technology, Gwangju Health University, Gwangju (Korea, Republic of); Kim, Kwang Cheol [Social Disaster Management Division, Jeollanamdo Provincial Government, Muan (Korea, Republic of)

    2016-11-15

    This study is aimed at suggesting the necessity of critical paths for the adverse reactions of contrast media, and investigating the ways to respond properly at the time of adverse reactions. The question on the size of hospitals in possession of CT equipment indicated that general hospitals accounted for 50% at the highest rate. In terms of job experience, 50% of radiological technologists had more than 10 years of experience, which accounted for the highest rate. It was shown that the average number of radiological technologists in the CT room was 3, that of nurses 0.6 and that of administrative workers and others 0.3 (87.5%) of respondents explained the treatment method of adverse reaction, and 97.5% responded that they were using the manual for the case of adverse reactions. Also, 87.5% of respondents indicated that they had the division of works at the time of adverse reaction, and the yearly average number of cases was 35. The average handling time was shown to be 51 minutes. This Emergency treatment manual and Critical Pathway program can be used as one of the patient care tools for reducing the adverse reactions to contrast media and increasing the efficiency of care process in CT examination settings.

  18. An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions

    DEFF Research Database (Denmark)

    Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne

    2017-01-01

    INTRODUCTION: Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region...

  19. Serious adverse reactions in a tuberculosis programme setting in Kyrgyzstan.

    Science.gov (United States)

    Hinderaker, S G; Ysykeeva, J; Veen, J; Enarson, D A

    2009-12-01

    Serious adverse reactions among new smear-positive patients were studied in a programme setting in Kyrgyzstan. Two per cent of patients on tuberculosis (TB) treatment had to interrupt treatment for > or =1 week, and more than 80% of the reactions occurred during the first month of treatment. Pyrazinamide was the most common causative agent, followed by rifampicin.

  20. Evaluation of Adverse Drug Reactions to Artemisinin-based ...

    African Journals Online (AJOL)

    ... to evaluate the incidence of adverse reactions to antimalarial drugs among residents of a Nigeria university community with a focus on artemisinin-based combination therapy (ACT). Specifically, the profile of use, and the reporting culture of people with respect to experienced reactions were noted. Method: Questionnaires ...

  1. Immune responses in dogs with cutaneous adverse food reactions

    NARCIS (Netherlands)

    Veenhof, E.Z.

    2012-01-01

    Background: Adverse food reactions (AFR) in dogs are reactions to apparently harmless food antigens, with an unknown etiology i.e. immunopathogenesis. In the majority of dogs with AFR, the signs are only associated with the skin (CAFR). Despite the entry of food allergens via the intestinal tract,

  2. Mechanisms in adverse reactions to food. The nose

    DEFF Research Database (Denmark)

    Høst, A

    1995-01-01

    Rhinitis is a common symptom in food allergic patients, but rhinitis is rarely the only symptom. Rhinitis due to adverse reactions to preservatives and colorants is very rare. In anaphylactic systemic reactions to foods the rhinitis symptoms are caused by inflammatory mediators transported...... by the circulation. In non-anaphylactic reactions, the nasal inflammation and symptoms are probably induced by interaction with food allergens transported to the nasal mucosa via the blood circulation....

  3. Late adverse reactions to intravascular iodinated contrast media

    Energy Technology Data Exchange (ETDEWEB)

    Webb, Judith A.W. [Department of Diagnostic Imaging, St. Bartholomew' s Hospital, London EC1A 7BE (United Kingdom); Stacul, Fulvio [Institute of Radiology, Ospedale di Cattinara, 34149 Trieste (Italy); Thomsen, Henrik S. [Department of Diagnostic Radiology 54E2, Copenhagen University Hospital at Herlev, Herlev Ringvej 75, 2730 Herlev (Denmark); Morcos, Sameh K. [Department of Diagnostic Imaging, Northern General Hospital, Sheffield Teaching Hospitals NHS Trust, Sheffield S5 7AU (United Kingdom)

    2003-01-01

    Late adverse reactions to intravascular iodinated contrast media are defined as reactions occurring 1 h to 1 week after contrast medium injection. They have received increasing interest over the past decade, but their prevalence remains uncertain and their pathophysiology is not fully understood. The Contrast Media Safety Committee of the European Society of Urogenital Radiology decided to review the literature and to issue guidelines. An extensive literature search was carried out and summarized in a report. Based on the available information, simple guidelines have been drawn up. The report and guidelines were discussed at the 8th European Symposium on Urogenital Radiology in Genoa. Late adverse reactions after intravascular iodinated contrast medium include symptoms such as nausea, vomiting, headache, itching, skin rash, musculoskeletal pain, and fever. A significant proportion of these reactions is unrelated to the contrast medium; however, allergy-like skin reactions are well-documented side effects of contrast media with an incidence of approximately 2%. Late reactions appear to be commoner after non-ionic dimers. The majority of late skin reactions after contrast medium exposure are probably T-cell-mediated allergic reactions. Patients at increased risk of late skin reactions are those with a history of previous contrast medium reaction and those on interleukin-2 treatment. Most skin reactions are self-limiting and resolve within a week. Management is symptomatic and similar to the management of other drug-induced skin reactions. (orig.)

  4. Pre-vaccination care-seeking in females reporting severe adverse reactions to HPV vaccine. A registry based case-control study

    DEFF Research Database (Denmark)

    Mølbak, Kåre; Hansen, Niels Dalum; Valentiner-Branth, Palle

    2016-01-01

    Background Since 2013 the number of suspected adverse reactions to the quadrivalent human papillomavirus (HPV) vaccine reported to the Danish Medicines Agency (DMA) has increased. Due to the resulting public concerns about vaccine safety, the coverage of HPV vaccinations in the childhood...... vaccination programme has declined. The aim of the present study was to determine health care-seeking prior to the first HPV vaccination among females who suspected adverse reactions to HPV vaccine. Methods In this registry-based case-control study, we included as cases vaccinated females with reports...... to the DMA of suspected severe adverse reactions.We selected controls without reports of adverse reactions from the Danish vaccination registry and matched by year of vaccination, age of vaccination, and municipality, and obtained from the Danish National Patient Registry and The National Health Insurance...

  5. [Adverse reactions induced by gadopentetate dimeglumine in magnetic resonance imaging].

    Science.gov (United States)

    Campos, A; de la Guardia, F; Reyes, J; Ferrero, C

    2007-09-01

    It is considered that the Gadolinium salts used as a contrast medium in the Magnetic Resonance Imaging (MRI) studies present an index of adverse reactions below the iodine contrast mediums. The main objective of this study is to determine, in our medium, the frequency and intensity of the adverse reactions related to the administration of Gadopentotate Dimeglumine (Gd-DTPA) and compare it with the rate of adverse reactions induced by the iodine contrast mediums. During the period comprised between 1st of January 2005 and 30th of June 2006, the adverse affects were collected for all the studies by means of MRI in which the Gd-DTPA contrast was applied, programmed or urgent, performed in Eresa Diagnosis Centres by Image located ( 11 centre in total) in the provinces of Castellón and Valencia. The adverse effects induced by the iodine salts were also collected in this period. A total of 54,909 studies with magnetic resonance were performed in the referred study centres, and 12,791 studies with MCI. The total of adverse reactions observed was 62 (0.11%) and 47 (0.36%) respectively. The profile of adverse reactions with both contrast mediums was similar, except in the moderate reactions where we objectively observed a greater percentage of palpebral edema and dyspnea with the usage of MCI than with Gd-DTPA. No cases of anaphylaxia or exitus were observed. The data contributed by this series support a safety profile of Gadolinium superior to that of the MCI in line with the results shown by extensive published series.

  6. Late adverse reactions to intravascular iodine based contrast media

    DEFF Research Database (Denmark)

    Bellin, Marie-France; Stacul, Fulvio; Webb, Judith A W

    2011-01-01

    DEFINITION: Late adverse reactions (LAR) to contrast media (CM) are defined as reactions occurring 1 h to 1 week after exposure. NEED FOR REVIEW: In view of more prospective studies of LAR and new data about their pathophysiology, the Contrast Medium Safety Committee (CMSC) of the European Society...... or delayed reading intradermal). The main risk factors for LAR are a previous reaction to contrast medium, a history of allergy, and interleukin-2 treatment. Most skin reactions are mild or moderate and self-limiting. MANAGEMENT: Management is symptomatic and similar to the management of other drug...

  7. An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions

    DEFF Research Database (Denmark)

    Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne

    2017-01-01

    INTRODUCTION: Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region of...... reporting and helps raise awareness about ADRs, including how and why they should be reported. Hopefully, this will assist national and European spontaneous reporting systems in their work to increase patient safety nationally and abroad....

  8. Chemical research on red pigments after adverse reactions to tattoo.

    Science.gov (United States)

    Tammaro, A; Toniolo, C; Giulianelli, V; Serafini, M; Persechino, S

    2016-03-01

    Currently, the incidence of tattooing is on the rise compared to the past, especially among adolescents, and it leads to the urgency of monitoring the security status of tattooing centers, as well as to inform people about the risks of tattoo practice. In our clinical experience, 20% of tattooed patients presented adverse reactions, like allergic contact dermatitis, psoriasis with Koebner's phenomena and granulomatous reactions, with the latter most prevalent and most often related to red pigment. Adverse reactions to tattoo pigments, especially the red one, are well known and described in literature. Great attention has to be focused on the pigments used, especially for the presence of new substances, often not well known. For this reason, we decided to perform a study on 12 samples of red tattoo ink, obtained by patients affected by different cutaneous reactions in the site of tattoo, to analyze their chemical composition.

  9. ADVERSE REACTIONS OF BLOOD DONATION: A PROSPECTIVE OBSERVATIONAL STUDY

    OpenAIRE

    Kandukuri Mahesh; Ravikanth; Chinthakindi; Shashi Kiran; Sudhir Kuma

    2014-01-01

    BACKGROUND: Voluntary donors normally tolerate blood donation very well as the history and preliminary examination is clear without any hidden history or facts related to the health status of the donor, occasionally, adverse reactions of variable severity may occur during or at the end of the collection. AIM: Aim of this study is to estimate and possibly avoid the cause of unwanted reactions. MATERIALS AND METHODS: This study is conducted over a period of three years, from ...

  10. Late adverse reactions to intravascular iodine based contrast media

    DEFF Research Database (Denmark)

    Bellin, Marie-France; Stacul, Fulvio; Webb, Judith A W

    2011-01-01

    DEFINITION: Late adverse reactions (LAR) to contrast media (CM) are defined as reactions occurring 1 h to 1 week after exposure. NEED FOR REVIEW: In view of more prospective studies of LAR and new data about their pathophysiology, the Contrast Medium Safety Committee (CMSC) of the European Society...... of Urogenital Radiology (ESUR) reviewed the literature on LAR and updated their guidelines. CLINICAL FEATURES AND PATHOLOGY: LAR after CM include symptoms such as nausea, vomiting, headache, itching, skin rash, musculoskeletal pain, and fever. Skin reactions are well-documented LAR to CM with an incidence...... of approximately 2%-4% after nonionic monomers. LAR are commoner by a factor of three to four after nonionic dimers. The commonest skin reactions are maculopapular rashes, erythema and skin swelling. These reactions are T cell-mediated immune reactions, and the diagnosis may be confirmed using skin tests (patch...

  11. [Extended abstractCutaneous Adverse Reactions to Tattoos].

    Science.gov (United States)

    van der Bent, S A S; Wolkerstorfer, A; Rustemeyer, T

    2016-01-01

    Tattooing involves the introduction of exogenous pigment into the dermis. Worldwide, tattoos are one of the most popular forms of permanent body art. In the Netherlands, 8-10% of the population older than 12 years old has a tattoo. A wide variety of cutaneous adverse effects can occur in tattoos, these can cause serious symptoms. However, recognition and appropriate knowledge of diagnosis and treatment is still frequently insufficient in many medical practitioners. The first case concerns a 57-year-old female, who developed an itching swelling in the red part of a tattoo on the left arm. Histology of a punch biopsy showed a pseudolymphomatous reaction. This plaque-like allergic reaction was successfully treated with intralesional injection of corticosteroids. Here we described four cases of cutaneous adverse reactions to tattoos. Allergic reactions in tattoos can present in a wide variety of clinical and histological patterns. The symptoms are often chronic itch and can appear weeks, months or years after placing the tattoo. Allergic reactions are uniformly manifested in one particular colour. Clinically, the reactions can present in a plaque-like, hyperkeratotic or rarely ulcerative or generalised reaction. In spite of changes to the compounds in tattoo inks, allergic reactions are still mostly observed to red ink. Treatment options are topical corticosteroids, intralesional injection of corticosteroids, laser treatment or dermatome shaving.

  12. Adverse drug reaction, patent blue V dye and anaesthesia

    Directory of Open Access Journals (Sweden)

    Swagata Tripathy

    2012-01-01

    Full Text Available Background and Aim: Patent blue vital (PBV dye is used for varied perioperative indications, and has a potential for causing life-threatening allergic reactions. In this retrospective case series study, at a tertiary level neurosciences centre, we analysed the nature, management and outcome of adverse drug reaction to the preoperative use of PBV for marking vertebral level prior to back surgeries. Methods: Patients were identified from the theatre and radiology database. Data were collected from the patients′ notes retrieved from the medical records division. Results: Eleven of 1247 (0.88% patients experienced adverse reactions: 6 (0.48% patients had minor grade I reactions (urticaria, blue hives, pruritis or generalised rash, 4 (0.32% had grade II reactions (transient hypotension/bronchospasm/laryngospasm and grade III reaction (hypotension requiring prolonged vasopressor support was noted in 1 (0.08% patient. No mortality was seen. The time of onset (range 10-45 min frequently coincided with induction of anaesthesia or prone positioning of patient. Seven (63.6% cases were cancelled or postponed (range 2-63 days. Treatment varied independent of the grade of reaction. Allergy workup (often incomplete was done for 6 (54% patients. Conclusion: An awareness of the time of onset and infrequency of life-threatening reactions to patent blue dye may result in better management, less postponement, more complete workup and referral of these events.

  13. Consumer adverse drug reaction reporting - A new step in pharmacovigilance?

    NARCIS (Netherlands)

    van Grootheest, K; de Graaf, L; de Jong-van den Berg, LTW

    2003-01-01

    The direct reporting of adverse drug reactions by patients is becoming an increasingly important topic for discussion in the world of pharmacovigilance. At this time, few countries accept consumer reports. We present an overview of experiences with consumer reporting in various countries of the

  14. Detection and Management of Adverse Drug Reactions Related to ...

    African Journals Online (AJOL)

    The objective of this study was to establish the detection, prevalence and management of various adverse drug reactions associated with antiretroviral drugs occurring in patients attending Comprehensive Care Centre (CCC) of Kiambu District Hospital. The study was a cross sectional survey where the patients included ...

  15. The concept of adverse drug reaction reporting: awareness among ...

    African Journals Online (AJOL)

    Adverse drug reaction (ADR) is poorly reported globally but more in developing countries with poor participation by health professionals. Currently, there is no known literature on the Nigerian pharmacy students' knowledge on ADR reporting. Hence the purpose of this study was to find out the level of knowledge of ...

  16. Glycaemic adverse drug reactions from anti-neoplastics used in ...

    African Journals Online (AJOL)

    235625 records ... Purpose: Pancreatic carcinoma is the most lethal cancer, with a 5‑year survival rate of <5%. Hyperglycemia is one of the severe adverse drug reactions (ADRs) in cancer treatment. The aim was to analyze the blood glucose‑related ADR of antineoplastics in treating pancreatic cancer. Materials and Methods: ...

  17. Knowledge, Attitude and Practice of Adverse Drug Reaction ...

    African Journals Online (AJOL)

    Results: Only 65 respondents filled and returned the questionnaire within the stipulated time frame giving a response rate of about 59.1 %. The standard yellow reporting form for adverse drug reactions was only known to 35.9 % of the participating health care workers. Only 42.7 % of the respondents had ever reported an ...

  18. Embolia cutis medicamentosa: an unusual adverse reaction to terlipressin

    Science.gov (United States)

    Gatos-Gatopoulos, Polychronis; Kostantoudakis, Stephanos; Panayiotides, Ioannis G.; Dimitriadis, George D.; Triantafyllou, Konstantinos

    2017-01-01

    Terlipressin is a synthetic long-acting analog of vasopressin widely used to control variceal bleeding by lowering portal venous pressure. We report an unusual adverse reaction to terlipressin in a 78-year-old patient with esophageal variceal bleeding who developed skin necrosis soon after treatment initiation. Skin biopsy revealed embolia cutis medicamentosa. PMID:29118569

  19. Evaluation of the adverse drug reaction surveillance system ...

    African Journals Online (AJOL)

    Results: The surveillance system did not meet up to its objectives as it failed to detect the adverse drug reactions and there was no monitoring of increases in known events. Fewer than half (43%) of the participants were aware of at least 2 objectives of the surveillance system but 83% of health workers willing to participate.

  20. Glycaemic Adverse Drug Reactions from Anti-Neoplastics Used in ...

    African Journals Online (AJOL)

    2018-01-24

    Jan 24, 2018 ... Purpose: Pancreatic carcinoma is the most lethal cancer, with a 5‑year survival rate of <5%. Hyperglycemia is one of the severe adverse drug reactions (ADRs) in cancer treatment. The aim was to analyze the blood glucose‑related ADR of antineoplastics in treating pancreatic cancer. Materials and ...

  1. Evaluating adverse drug reactions among HAART patients in a ...

    African Journals Online (AJOL)

    The high prevalence of HIV in KwaZulu-Natal Province, South Africa, has greatly increased the demand for antiretroviral therapy (ART), resulting in an exponential increase in the number of patients initiated on highly active antiretroviral treatment (HAART). However, little information about adverse drug reactions in these ...

  2. Adverse drug reaction reporting among health care workers at ...

    African Journals Online (AJOL)

    Background: Adverse Drug Reactions (ADRs) are an important contributor to patient morbidity and hospitalisation in Uganda. Under-reporting of ADRs may increase medicine-induced morbidity and mortality among patients. This study determined the extent of ADR reporting, and associated factors, among healthcare ...

  3. adverse drug reactions among hiv infected and uninfected adults ...

    African Journals Online (AJOL)

    East African Medical Journal Vol. 88 No. 10 October 2011. ADVERSE DRUG REACTIONS AMONG HIV INFECTED AND UNINFECTED ADULTS RECEIVING ANTI-. TUBERCULOUS THERAPY AT KENYATTA NATIONAL HOSPITAL. J. O. Masese, M. Pharm (Clin. Pharm), Department of Pharmaceutics and Pharmacy ...

  4. Adverse reactions to ants other than imported fire ants.

    Science.gov (United States)

    Klotz, John H; deShazo, Richard D; Pinnas, Jacob L; Frishman, Austin M; Schmidt, Justin O; Suiter, Daniel R; Price, Gary W; Klotz, Stephen A

    2005-11-01

    To identify ants other than Solenopsis invicta and Solenopsis richteri reported to cause adverse reactions in humans. We conducted a literature review to identify reports of medical reactions to ants other than S. invicta and S. richteri. Our review of medical and entomological literature on stinging ants was generated from MEDLINE and FORMIS, respectively, using the key words stinging ants and ant stings. The search was limited to articles in English published from 1966 to 2004 on MEDLINE and all years on FORMIS. We also present 3 new case reports of severe reactions to stings by 2 different species of ants, Pseudomyrmex ejectus and Hypoponera punctatissima. Articles that concerned anaphylactic (IgE-mediated) or anaphylactic-like (resembling anaphylaxis but mechanism unknown) immediate reactions to ant stings or bites were included in this review. Taken together, our data demonstrate that S. invicta and S. richteri are not alone in their capability to cause serious allergic or adverse reactions. A diverse array of ant species belonging to 6 different subfamilies (Formicinae, Myrmeciinae, Ponerinae, Ectatomminae, Myrmicinae, and Pseudomyrmecinae) and 10 genera (Solenopsis, Formica, Myrmecia, Tetramorium, Pogonomyrmex, Pachycondyla, Odontomachus, Rhytidoponera, Pseudomyrmex, and Hypoponera) have now been shown to have this capability. Awareness that species other than imported fire ants may cause severe reactions should lead to more rapid evaluation and treatment and further investigation of the medical entomology of these ants.

  5. Application of the Apriori algorithm for adverse drug reaction detection.

    Science.gov (United States)

    Kuo, M H; Kushniruk, A W; Borycki, E M; Greig, D

    2009-01-01

    The objective of this research is to assess the suitability of the Apriori association analysis algorithm for the detection of adverse drug reactions (ADR) in health care data. The Apriori algorithm is used to perform association analysis on the characteristics of patients, the drugs they are taking, their primary diagnosis, co-morbid conditions, and the ADRs or adverse events (AE) they experience. This analysis produces association rules that indicate what combinations of medications and patient characteristics lead to ADRs. A simple data set is used to demonstrate the feasibility and effectiveness of the algorithm.

  6. [Cutaneous adverse drug reaction: prospective study of 118 cases].

    Science.gov (United States)

    Chaabane, Hend; Masmoudi, Abderrahmen; Amouri, Meriem; Ghorbel, Sonda; Boudaya, Sonia; Hammami, Serriya; Zghal, Khaled; Turki, Hamida

    2013-01-01

    Few prospective studies are available on the incidence and analysis of the characteristics of adverse cutaneous drug reactions. To describe the adverse cutaneous reactions, their epidemiologic characteristics as well as the different causative drugs through a prospective hospital study. A 12-month prospective study was managed in our department of dermatology of the teaching hospital Hedi Chaker of Sfax. Requested information included patient characteristics (associated disorders), drug intake (list and chronology of the drug intake during the 3 weeks preceding the adverse reaction) and characteristics of the skin reaction (type, course). The diagnosis was based on a beam of clinical and anamnestic arguments. The drug imputability was evaluated according to the Begaud's French method. One hundred eighteen cases were collected. A prevalence of 1.08/100 among patients consulting in dermatology department was estimated. The macular and papular exanthema represented the most frequent clinical aspects (42 cases) followed by acute urticaria (23 cases), photosensitivity (19 cases) and fixed drug eruption (15 cases). Principal imputable drugs were antibiotics, mainly penicillins followed by analgesics and non-steroidal anti-inflammatory. Although it was monocentric, this study revealed a high frequency of drug-induced dermatitis with different clinical presentation. The high incidence of drug-induced dermatitis induced by antibiotics, analgesics and anti-inflammatory is due to their widespread use, often in self-medication.

  7. Cutaneous adverse drug reaction in a dog associated with imepitoin.

    Science.gov (United States)

    Royaux, Emilie; Bhatti, Sofie; De Cock, Hilde; Van Ham, Luc; Kitshoff, Adriaan; Vandenabeele, Sophie

    2016-04-01

    The macroscopic appearance of cutaneous adverse drug reactions can be similar to a plethora of skin diseases and in particular may resemble autoimmune and immune-mediated disorders. The reaction can occur after single or multiple administrations, with the latter varying in durations of up to years of treatment. These reactions are mostly self-limiting with cessation of the offending drug. To report a cutaneous adverse drug reaction associated with chronic administration of imepitoin. A 4-year-old, Jack Russell terrier dog was presented with progressive skin lesions of 1-week duration. The dog had a 6 month history of idiopathic epilepsy treated with imepitoin for the previous 5 months. Imepitoin is an anti-epileptic drug that acts as a low-affinity partial agonist of the benzodiazepine site at the GABAA receptor. The dosage of imepitoin was increased from 20 mg/kg twice daily to 30 mg/kg twice daily, 3 days before the onset of skin lesions, due to uncontrolled seizures. [Correction added on 15 February 2016 after first online publication: In the preceding sentence, the dosage of imepitoin was previously incorrect and has been amended in this current version.] Dermatological examination revealed erythema and exfoliation at the mucocutaneous junctions of the lips, lip folds, philtrum, ears, axillae and the ventral abdomen. Small erosions and depigmentation were visible on the oral mucosa, lip folds and philtrum. Histopathology was supportive of a lupoid drug reaction. Complete resolution of skin lesions was seen after discontinuation of imepitoin and low dose of prednisolone during a period of 4 weeks. No recrudescence of skin lesions was observed during a 6 month follow-up period. Imepitoin may result in cutaneous adverse drug reactions in dogs. © 2016 ESVD and ACVD.

  8. Identification of possible adverse drug reactions in clinical notes

    DEFF Research Database (Denmark)

    Warrer, Pernille; Jensen, Peter Bjødstrup; Aagaard, Lise

    2015-01-01

    Objective: Through manual review of clinical notes for patients with type 2 diabetes mellitus attending a Danish diabetes center, the aim of the study was to identify adverse drug reactions (ADRs) associated with three classes of glucose-lowering medicines: "Combinations of oral blood-glucose low......Objective: Through manual review of clinical notes for patients with type 2 diabetes mellitus attending a Danish diabetes center, the aim of the study was to identify adverse drug reactions (ADRs) associated with three classes of glucose-lowering medicines: "Combinations of oral blood...... information is generally available for causality assessment. However, manual review of clinical notes is too time-consuming for routine use and hence there is a need for developing information technology (IT) tools for automatic screening of patient records with the purpose to detect information about...

  9. Adverse cutaneous reactions induced by exposure to woods

    Directory of Open Access Journals (Sweden)

    Dorota Chomiczewska-Skóra

    2013-02-01

    Full Text Available Various adverse cutaneous reactions may occur as a result of exposure to wood dust or solid woods. These include allergic contact dermatitis, irritant contact dermatitis and, more rarely, contact urticaria, photoallergic and phototoxic reactions. Also cases of erythema multiforme-like reactions have been reported. Contact dermatitis, both allergic and irritant, is most frequently provoked by exotic woods, e.g. wood of the Dalbergia spp., Machaerium scleroxylon or Tectona grandis. Cutaneous reactions are usually associated with manual or machine woodworking, in occupational setting or as a hobby. As a result of exposure to wood dust, airborne contact dermatitis is often diagnosed. Cases of allergic contact dermatitis due to solid woods of finished articles as jewelry or musical instruments have also been reported. The aim of the paper is to present various adverse skin reactions related to exposure to woods, their causal factors and sources of exposure, based on the review of literature. Med Pr 2013;64(1:103–118

  10. Clinical and economic burden of adverse drug reactions

    OpenAIRE

    Sultana, Janet; Cutroneo, Paola; Trifir?, Gianluca

    2013-01-01

    Adverse drug reactions (ADRs) are unwanted drug effects that have considerable economic as well as clinical costs as they often lead to hospital admission, prolongation of hospital stay and emergency department visits. Randomized controlled trials (RCTs) are the main premarketing methods used to detect and quantify ADRs but these have several limitations, such as limited study sample size and limited heterogeneity due to the exclusion of the frailest patients. In addition, ADRs due to inappro...

  11. Ludwig's Angina: A Nightmare Worsened by Adverse Drug Reaction to Antibiotics.

    Science.gov (United States)

    Hisham, Mohamed; Sivakumar, Mundilipalayam N; Senthil Kumar, R S; Nandakumar, P

    2017-03-01

    A 52-year-old obese gentleman presented to the hospital with complaints of fever and shortness of breath for 10 days. He was admitted in the ward and treated for acute exacerbation of asthma. He was shifted to the Intensive Care Unit (ICU) for persistent fever, neck swelling, airway obstruction and desaturation. Ludwig's angina was suspected and computed tomography of neck confirmed it. A difficult airway was anticipated and preceded with surgical tracheostomy. The patient had hypersensitivity reactions to piperacillin/tazobactam; hence, he was treated with clindamycin and metronidazole. The patient improved and was discharged after five days of ICU stay and 12 days of hospitalization. This case summarizes the rare incidence of Ludwig's angina with antibiotic adverse reactions. If angioneurotic edema is coincidental with features of Ludwig's angina, it becomes more challenging. Early identification, securing the airway, and antibiotic administration are the keystone to better survival.

  12. [Adverse cutaneous reactions to drugs among hospitalized patients: a one year surveillance].

    Science.gov (United States)

    Danza, Alvaro; López, Maynés; Vola, Magdalena; Alvarez-Rocha, Alfredo

    2010-11-01

    Adverse cutaneous reactions to Drugs (CDRs) are of particular interest among all adverse Drug reactions (ADR) due to their frequency, potential severity and because of the importance of an early diagnosis. Antimicrobial agents, anticonvulsants and non-steroidal anti-inflammatory Drugs are the Drugs associated to the highest risk of CDRs. To assess CDRs in hospitalized patients and identify the Drugs involved. All patients hospitalized in the Hospital de Clínicas in Montevideo, Uruguay, with suspected CDRs, detected during one year, were included in this prospective study. The imputability was established using the Karch and Lasagna algorithm modified by Naranjo. We analyzed age, gender, Drugs involved, causal disease, severity, latency and evolution. Seventeen patients, aged 17 to 85 years (15 females) with CDRs were identifed. Twelve had morbilliform exanthemas, four had reactions with eosinophilia and systemic symptoms and one had a Stevens Johnson syndrome. The Drugs involved were antimicrobials in nine cases, hypouricemic agents in four cases, anticonvulsants in three cases and aspartic insulin in one. Twelve patients had a life threatening reaction and one required admission to the intensive care unit. No deaths occurred. CDRs were more common in women and most of them were caused by antimicrobial agents.

  13. Unravelling adverse reactions to NSAIDs using systems biology.

    Science.gov (United States)

    Perkins, James R; Sanak, Marek; Canto, Gabriela; Blanca, Miguel; Cornejo-García, José Antonio

    2015-03-01

    We introduce the reader to systems biology, using adverse drug reactions (ADRs), specifically hypersensitivity reactions to multiple non-steroidal anti-inflammatory drugs (NSAIDs), as a model. To disentangle the different processes that contribute to these reactions - from drug intake to the appearance of symptoms - it will be necessary to create high-throughput datasets. Just as crucial will be the use of systems biology to integrate and make sense of them. We review previous work using systems biology to study related pathologies such as asthma/allergy, and NSAID metabolism. We show examples of their application to NSAIDs-hypersensitivity using current datasets. We describe breakthroughs in high-throughput technology and speculate on their use to improve our understanding of this and other drug-induced pathologies. Copyright © 2014 Elsevier Ltd. All rights reserved.

  14. Review of adverse reactions to injections of Chinese materia medica.

    Science.gov (United States)

    Bian, Zhaoxiang; Shang, Hongcai; Cheng, Chungwah; Wu, Taixiang; Li, Youping; Zhang, Boli

    2010-05-01

    Using Chinese Materia Medica (CM) as injections is an innovation that is proving effective in extensive clinical use in Mainland China. However, recent reports have focused on adverse reactions, ignoring the considerable successes of these preparations. In order to achieve balance in the media and in the minds of the public, we suggest the first step is to clarify the concepts of and differences between adverse drug reactions (ADR) and adverse events (AE) for all concerned-the public, medical practitioners, government officials, and lawmakers. Second, the State Food and Drug Administration should raise the requirements for Chinese Materia Medica Injection (CMI) registration and license approval and emphasize the importance of evidence-based CMI development and evidence-based CMI license approval. Thirdly, drug companies and institutions should reinforce basic research about the quality control of herbs and CMI-drug interactions. Fourth, the Government should clarify the legal responsibilities for CMI approval agencies, CMI developers, medical doctors, and patients. Fifth, the medical association and Government should enhance training for health care professionals concerning the usage of CMIs. And finally sixth, State Food and Drug Administration should monitor the content and quality of the directions for use of CMI. © 2010 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.

  15. Pharmacogenetic markers of severe cutaneous adverse drug reactions.

    Science.gov (United States)

    Borroni, R G

    2014-04-01

    Different responses, in terms both of efficacy and toxicity, are commonly observed for any drug administered to apparently homogeneous groups of patients. It is estimated that adverse drug reactions (ADRs) cause 3-6% of all hospitalizations, accounting for 5% to 9% of hospital admission costs. The skin is often involved in ADRs and although most cutaneous ADRs have a favorable course, they may present as severe adverse cutaneous drug reactions (SCARs), such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (also referred to as drug-induced hypersensitivity syndrome), and acute generalized exanthematous pustulosis. SCARs are associated with significant mortality and require prompt diagnosis and adequate treatment. Pharmacogenetics studies individual variants in the DNA sequence associated with drug efficacy and toxicity, allowing prescription of a drug to patients expected to benefit from it, and excluding from treatment those who are at risk of developing ADRs. Pharmacogenetics already achieved several important results in the prevention of SCARs, and pharmacogenetic testing is now recommended by regulatory agencies before administration of abacavir and carbamazepine, leading to reduced incidence of SCARs. In this review, the pharmacogenetic associations of SCARs that have been validated in independent, case-control association studies will be presented. By familiarizing with principles of pharmacogenetics, dermatologists should be able to correlate specific cutaneous ADR phenotypes to the underlying genotype, thus contributing to better drug safety and facilitating drug discovery, development and approval.

  16. Spontaneous adverse drug reaction reporting in rural districts of Mozambique.

    Science.gov (United States)

    Sevene, Esperança; Mariano, Alda; Mehta, Ushma; Machai, Maria; Dodoo, Alexander; Vilardell, David; Patel, Sam; Barnes, Karen; Carné, Xavier

    2008-01-01

    The roll out of various public health programmes involving mass administration of medicines calls for the deployment of responsive pharmacovigilance systems to permit identification of signals of rare or even common adverse reactions. In developing countries in Africa, these systems are mostly absent and their performance under any circumstance is difficult to predict given the known shortage of human, financial and technical resources. Nevertheless, the importance of such systems in all countries is not in doubt, and research to identify problems, with the aim of offering pragmatic solutions, is urgently needed. To examine the impact of training and monitoring of healthcare workers, making supervisory visits and the availability of telecommunication and transport facilities on the implementation of a pharmacovigilance system in Mozambique. This was a descriptive study enumerating the lessons learnt and challenges faced in implementing a spontaneous reporting system in two rural districts of Mozambique - Namaacha and Matutuíne - where remote location, poor telecommunication services and a low level of education of health professionals are ongoing challenges. A 'yellow card' system for spontaneous reporting of adverse drug reactions (ADRs) was instituted following training of health workers in the selected districts. Thirty-five health professionals (3 medical doctors, 2 technicians, 24 nurses, 4 basic healthcare agents and 2 pharmacy agents) in these districts were trained to diagnose, treat and report ADRs to all medicines using a standardized yellow card system. There were routine site visits to identify and clarify any problems in filling in and sending the forms. One focal person was identified in each district to facilitate communication between the health professionals and the National Pharmacovigilance Unit (NPU). The report form was assessed for quality and causality. The availability of telecommunications and transport was assessed. Fourteen months after

  17. Adverse reactions to contrast media: an analysis of spontaneous reports in the database of the pharmacovigilance programme of India.

    Science.gov (United States)

    Kalaiselvan, Vivekanandan; Sharma, Surbhi; Singh, Gyanendra Nath

    2014-09-01

    Contrast media are used widely to improve medical imaging. Like all other pharmaceuticals, these agents are not completely devoid of risk, and continuous monitoring of adverse reactions with these agents is important. Spontaneous reporting is the simplest method for understanding the safety profile of pharmaceutical products after their approval. Our objective was to identify the pattern and characteristics of adverse reactions attributed to contrast media in the Indian population reported to the National Coordination Centre for the Pharmacovigilance Programme of India (NCC-PvPI). Individual case safety reports (ICSRs) attributed to contrast media submitted spontaneously to the NCC-PvPI were extracted from the database for July 2010 to September 2013. We analysed these reports for information related to reporter's professional category, patient's age and sex, reporter's diagnosis of the reaction, seriousness of the reaction, type of contrast media exposure, system organ class (SOC) affected (as described in World Health Organization Adverse Reaction Terminology [WHO-ART]) and outcome. Of the total 59,915 ICSRs in the database, 415 (0.7%) were suspected adverse reactions to contrast media; 44 reports were serious, including three fatal cases. The most affected SOCs were skin and appendage disorders, body as a whole-general disorders, gastrointestinal system disorders and respiratory system disorders. Hypersensitivity reactions were reported in the majority of ICSRs. The contrast media with the highest number of reports were iohexol (40.7%), iomeprol (17.8%), iopamidol (12%) and diatrizoate (12%). Most of the reactions to contrast media were allergic-like, and no previously unrecognised adverse reactions were observed in the Indian population. Further data and increased awareness among healthcare professionals is required to signal and prevent the consequences of adverse reactions attributed to contrast media.

  18. Adverse drug reactions from psychotropic medicines in the paediatric population

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba H

    2010-01-01

    of these products in childhood. Little evidence has been reported about the adverse drug reactions (ADRs) of these medicines in practice. As spontaneous reports are the main source for information about previously unknown ADRs, we analysed data submitted to a national ADR database. The objective was to characterise......ABSTRACT: BACKGROUND: The prescribing of psychotropic medicines for the paediatric population is rapidly increasing. In attempts to curb the use of psychotropic medicine in the paediatric population, regulatory authorities have issued various warnings about risks associated with use...

  19. Adverse drug reactions in the paediatric population in Denmark

    DEFF Research Database (Denmark)

    Aagaard, Lise; Weber, Camilla Blicher; Hansen, Ebba Holme

    2010-01-01

    BACKGROUND: The potential risk of adverse drug reactions (ADRs) in the paediatric population has become a public health concern and regulatory agencies in Europe and the US have acknowledged that there is a need for more research in this area. Spontaneous reporting systems can provide important new...... information about ADRs. OBJECTIVE: To characterize ADRs in children reported in Denmark over a period of one decade. METHODS: We analysed ADRs reported to the Danish Medicines Agency from 1998 to 2007 for individuals aged from birth to 17 years. Data were analysed with respect to time, age and sex, category...

  20. Clinical Indications and Adverse Reactions of Platelet Apheresis.

    Science.gov (United States)

    Amanat, Samina Tufail; Shakoor, Huma Abdul; Raza, Masooma; Khan, Nadeem; Rauf, Abdul

    2015-06-01

    To determine the clinical indications and adverse reactions of platelet apheresis procedure. Cross-sectional, observational study. Blood Bank of Pakistan Atomic Energy Commission General Hospital, Islamabad, from January 2010 to December 2014. Indications and adverse reaction verified for 200 consecutive platelet apheresis donations performed for 125 patients was included in this study. Data was analysed for descriptive variables using SPSS version 16. Donor deferral rate in the study was 63.83%. All the donors were males (100%) and replacement donors. Most prevalent blood type was B-positive (n=63, 31.5%), followed by O-positive (n=59, 29.5%). Rh negative groups constituted 13.5% (n=27) of all the donors. Average age of platelet apheresis donors was 28.56 ± 5.77 years. Maximum numbers of donors were in age range 20 - 30 years. Average weight of the donors was 73.96 ± 11.96 kg. Mean pre-procedure platelet count of donors was 268,000/µL. The postprocedure average platelet count was approximately 200,000/µL. The mean duration of a platelet apheresis session was 78.27 ± 26.07 minutes. Average volume of the final product was 412.53 ± 45.33 ml. Average volume of anti-coagulant acid citrate dextrose used per procedure was 300 ± 40 ml, 245 ml returned to donor along with returned blood while 55 ml used as anticoagulant in final concentrate. Of total 200, two (1%) final products were contaminated with red cells. Three (1.5%) products were not issued and finally expired. Of the 125 patients for which plateletpheresis procedures were performed, 54 (43.2%) patients were males and 71 (56.8%) were females (M: F=0.76:1). Six donors (3%) had adverse events: three donors (1.5%) had mild reactions, two (1%) moderate reaction, and one donor (0.5%) developing hematoma. None had severe or life-threatening reactions. Plateletpheresis procedure is relatively safe and forms an important adjuvant to blood bank inventory.

  1. Adverse drug reactions induced by cardiovascular drugs in outpatients

    Directory of Open Access Journals (Sweden)

    Gholami K

    2008-03-01

    Full Text Available Considering increased use of cardiovascular drugs and limitations in pre-marketing trials for drug safety evaluation, post marketing evaluation of adverse drug reactions (ADRs induced by this class of medicinal products seems necessary.Objectives: To determine the rate and seriousness of adverse reactions induced by cardiovascular drugs in outpatients. To compare sex and different age groups in developing ADRs with cardiovascular agents. To assess the relationship between frequencies of ADRs and the number of drugs used. Methods: This cross-sectional study was done in cardiovascular clinic at a teaching hospital. All patients during an eight months period were evaluated for cardiovascular drugs induced ADRs. Patient and reaction factors were analyzed in detected ADRs. Patients with or without ADRs were compared in sex and age by using chi-square test. Assessing the relationship between frequencies of ADRs and the number of drugs used was done by using Pearson analysis. Results: The total number of 518 patients was visited at the clinic. ADRs were detected in 105 (20.3% patients. The most frequent ADRs were occurred in the age group of 51-60. The highest rate of ADRs was recorded to be induced by Diltiazem (23.5% and the lowest rate with Atenolol (3%. Headache was the most frequent detected ADR (23%. Assessing the severity and preventability of ADRs revealed that 1.1% of ADRs were detected as severe and 1.9% as preventable reactions. Women significantly developed more ADRs in this study (chi square = 3.978, P<0.05. ADRs more frequently occurred with increasing age in this study (chi square = 15.871, P<0.05. With increasing the number of drugs used, the frequency of ADRs increased (Pearson=0.259, P<0.05. Conclusion: Monitoring ADRs in patients using cardiovascular drugs is a matter of importance since this class of medicines is usually used by elderly patients with critical conditions and underlying diseases.

  2. Evaluation of adverse reactions to contrast media in the hospital

    Science.gov (United States)

    Ryu, J-H; Kim, E-Y

    2013-01-01

    Objective: To determine and analyse the characteristics of contrast media adverse reactions (CM-ARs) reported in a hospital. Methods: A retrospective review of CM-ARs from the electronic spontaneous adverse drug reaction (ADR) report system between January 2011 and August 2012 was conducted. CM-ARs were evaluated in terms of causality, severity, preventability and affected organs. Also, agreement and correlation among the tools used to evaluate CM-ARs were analysed. Results: The overall reaction rate was 1.5% (n = 286). In total, 269 CM-ARs were identified. For ADR causality, 96.7% (n = 260) and 98.5% (n = 265) were evaluated as “probable” ADR using the Naranjo probability scale and the World Health Organization–Uppsala Monitoring Centre causality categories, whereas 98.1% (n = 264) were evaluated as “certain” with Korean algorithm v. II. Of these, 91.4% (n = 246) were mild in severity and 96.7% (n = 260) were unpreventable. Most patients (n = 233, 86.7%) could be managed with observation and/or simple treatment. The most frequent reaction (n = 383, 79.5%) was dermatological. Spearman's correlation coefficient was 0.667 (p < 0.01), and the agreement was 98.1% between the Naranjo scale and the World Health Organization–Uppsala Monitoring Centre categories. No relationship was seen between CM-AR severity and gender or between in- and outpatients. Conclusion: In our study, most CM-ARs were mild and managed with simple treatment. However, as the number of patients undergoing CT procedures continues to increase, it is essential to identify and observe patients at risk for CM-ARs to prevent severe ADRs. Advances in knowledge: Continuous careful review of reporting and treatment protocols of CM-ARs is needed to prevent morbidity and mortality. PMID:24191123

  3. Identification of possible adverse drug reactions in clinical notes

    DEFF Research Database (Denmark)

    Warrer, Pernille; Jensen, Peter Bjødstrup; Aagaard, Lise

    2015-01-01

    OBJECTIVE: Through manual review of clinical notes for patients with type 2 diabetes mellitus attending a Danish diabetes center, the aim of the study was to identify adverse drug reactions (ADRs) associated with three classes of glucose-lowering medicines: "Combinations of oral blood-glucose low......OBJECTIVE: Through manual review of clinical notes for patients with type 2 diabetes mellitus attending a Danish diabetes center, the aim of the study was to identify adverse drug reactions (ADRs) associated with three classes of glucose-lowering medicines: "Combinations of oral blood...... and labeling status. FINDINGS: A total of 207 patients were included in the study leading to the identification of 163 AEs. 14% were categorized as certain, 60% as probable/likely, and 26% as possible. 15 (9%) ADRs were unlabeled of which two were serious: peripheral edema associated with sitagliptin...... and stomach ulcer associated with liraglutide. Of the unlabeled ADRs, 13 (87%) were associated with "other blood glucose lowering medications," the remaining 2 (13%) with "DDP-4 inhibitors." CONCLUSION: Clinical notes could potentially reveal unlabeled ADRs associated with prescribed medicines and sufficient...

  4. Identification of possible adverse drug reactions in clinical notes

    DEFF Research Database (Denmark)

    Warrer, Pernille; Jensen, Peter Bjødstrup; Aagaard, Lise

    2015-01-01

    Objective: Through manual review of clinical notes for patients with type 2 diabetes mellitus attending a Danish diabetes center, the aim of the study was to identify adverse drug reactions (ADRs) associated with three classes of glucose-lowering medicines: "Combinations of oral blood-glucose low......Objective: Through manual review of clinical notes for patients with type 2 diabetes mellitus attending a Danish diabetes center, the aim of the study was to identify adverse drug reactions (ADRs) associated with three classes of glucose-lowering medicines: "Combinations of oral blood...... and labeling status. Findings: A total of 207 patients were included in the study leading to the identification of 163 AEs. 14% were categorized as certain, 60% as probable/likely, and 26% as possible. 15 (9%) ADRs were unlabeled of which two were serious: peripheral edema associated with sitagliptin...... and stomach ulcer associated with liraglutide. Of the unlabeled ADRs, 13 (87%) were associated with "other blood glucose lowering medications," the remaining 2 (13%) with "DDP-4 inhibitors." Conclusion: Clinical notes could potentially reveal unlabeled ADRs associated with prescribed medicines and sufficient...

  5. Adverse drug reactions amongst adult patients admitted in Lagos State University Teaching Hospital Lagos, Nigeria.

    Science.gov (United States)

    Aderemi-Williams, R I; Awodele, O; Boyle, C A

    2015-01-01

    Adverse drug reaction (ADR) is a global drug therapy problem. It has been rated as one of the top leading causes of morbidity and mortality. In Nigeria, not much is known about ADRs especially with the existing weak post marketing surveillance for monitoring drug use, and its effect on the population. The study is aimed at determining the incidence of ADRs, presentations of ADRs, classes of drugs that frequently cause ADRs and predictors of ADRs in adult medical in-patients in LASUTH. A retrospective study of six hundred and twenty four (624) case notes of all patients admitted to the medical wards in LASUTH between January 1, 2009 and December 31, 2009 was carried out. Information obtained included age, gender, and adverse drug reaction and drug details. The results obtained were analyzed using SPSS version 16 statistical software. Level of significance was set at p ≤ 0.05. A total of 624 case notes consisting of 358 males and 266 females were assessed. The number of patients who experienced adverse drug reactions was 67 (n = 624, 10.7%). The incidence rate of ADRs in LASUTH from the study was 10.7 per 100 patients' population. Most of the ADRs observed were type A reactions (97.8%). Mostly implicated classes of drugs were antidiabetics (26.7%) and NSAIDs (29.3%). The incidence rate of ADRs was 10.7%. ADRs which are predictable and preventable occur in hospitalized patients, such may be prevented or minimized by implementing measures to target specific drugs that are commonly suspected.

  6. Adverse cutaneous drug reactions: Eight year assessment in hospitalized patients

    Directory of Open Access Journals (Sweden)

    Fatemeh Mokhtari

    2014-01-01

    Full Text Available Background: Adverse cutaneous drug reactions (ACDRs are the most commonly reported adverse drug events. The causative drugs and clinical patterns of ACDRs are different in various populations. This study was conducted to identify the clinical patterns, causative drugs and reasons for drug administration in patients hospitalized due to ACDR. Materials and Methods: This retrospective study was carried out in a referral university hospital, Isfahan, Iran. The medical records of all patients who were hospitalized in the Dermatology Department due to ACDRs were reviewed covering an 8-year period between December 2006 and August 2013. Results: A total number of 282 patients with the mean age of 29.48 ± 21.18 years were hospitalized in this time period, of which 61% were females. The most common clinical patterns regarding the final diagnosis were Stevens-Johnson syndrome (SJS (32%, exanthematous drug eruptions (24.5% and toxic epidermal necrolysis (TEN (11%. Anticonvulsants were the most frequently implicated drug group (51.8% followed by antibiotics (33.7% and analgesics and non-steroidal anti-inflammatory drugs (5.7%. The most common cause of drug administration was seizure (30% and then upper respiratory tract infections (12%. The frequency distribution of clinical types of reactions was different between age groups (P < 0.001. The severe types (SJS, TEN, drug rash with eosinophilia and systemic symptoms and overlap syndrome were more frequent in the patients aged ≤50 years old (55.2% compare to those aged ≤50 years (28% (P = 0.001. Conclusion: The main causative drugs of ACDRs were anticonvulsants and antibiotics. However, the sever types of reactions were more prevalent.

  7. Oxidative stress and leukocyte migration inhibition response in cutaneous adverse drug reactions.

    Science.gov (United States)

    Verma, Prashant; Bhattacharya, Sambit Nath; Banerjee, Basu Deb; Khanna, Naresh

    2012-01-01

    Cutaneous adverse drug reactions (CADRs) may either be immunological or non-immunological. The precise mechanisms, however, are largely obscure. Other concomitant mechanisms may amplify and/or contribute to the severity and duration of a reaction. One such mechanism could be oxidative stress, a state of imbalance between reactive oxygen species, and their subsequent detoxification by antioxidants. (a) to assess the oxidative stress status in the blood of cutaneous drug reaction patients by assaying for reduced glutathione (GSH) and malondialdehyde (MDA) levels, (b) to determine the leukocyte migration inhibition (LMI) response in these patients in response to the suspected drug (s), and (c) to look for the association between oxidative stress parameters and LMI. Ethical committee approval was obtained for this study. Fresh venous blood samples were obtained from the patients of CADRs (group A) during the acute phase of reaction and healthy control subjects (group B). MDA levels, a measure of oxidative lipid damage, and reduced GSH levels, a measure of anti-oxidant capacity, were assayed in the blood samples of both groups using spectrophotometry. LMI response was measured by challenging the patients' peripheral blood mononuclear cells with the suspected drug to confirm immunological perturbation. Totally 66 participants, 33 cases in group A and equal number of controls in group B, were studied. The mean MDA levels were found to be raised (P urticaria (3/25), exfoliative dermatitis (2/25), morbilliform rash (2/25), erythroderma (1/25), vasculitis (1/25), and dapsone syndrome (1/25). The mean MDA levels were found to be significantly higher in the LMI positive CADRs (P stress based on MDA and GSH levels in the peripheral blood. There is a significant positive correlation of LMI response (against the causative drug) with MDA levels, which strongly associates oxidative stress with the immunopathogenesis in CADRs.

  8. Adverse Reactions to Antituberculosis Drugs in Iranian Tuberculosis Patients

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    Aliasghar Farazi

    2014-01-01

    Full Text Available Background. Antituberculosis multidrug regimens have been associated with increased incidence of adverse drug reactions (ADRs. This study aimed to determine the incidence and associated factors of ADRs due to antituberculosis therapy. Methods. This is a retrospective cross-sectional study on tuberculosis patients who were treated in tuberculosis clinics in Markazi province in Iran. The information contained in the medical files was extracted and entered into the questionnaire. Data was descriptively analyzed by using statistical package for social sciences (SPSS 18. Results. A total of 940 TB patients of 1240 patients’ medical records available in 10 medical offices were included in this study. Of the 563 ADRs found in this study, 82.4% were considered minor reactions and 17.6% were major reactions. No death from antituberculosis ADR was observed. We found that the risk of major ADRs was higher in females (P  value=0.0241, age >50 y (P  value=0.0223, coinfection with HIV (P  value=0.0323, smoking (P  value=0.002, retreatment TB (P  value=0.0203, and comorbidities (P  value=0.0005. Conclusions. This study showed that severe side effects of anti-TB drugs are common in patients who have risk factors of ADRs and they should be followed up by close monitoring.

  9. Adverse reactions to psychedelic drugs. A review of the literature.

    Science.gov (United States)

    Strassman, R J

    1984-10-01

    The use of naturally occurring and synthetically derived compounds for their "psychedelic" effects has been a part of human culture for thousands of years. The basic pharmacology of the major synthetic psychedelic compounds (primarily lysergic acid diethylamide [LSD]-25) is described and reference is made to their potentially beneficial psychological effects. Adverse reactions, defined as dysphoric and/or maladaptive/dysfunctional responses to the use of these drugs, sometimes require careful clinical judgment in order to diagnose. These reactions can be effectively classified along a temporal continuum. Acute, short-lived reactions are often fairly benign, whereas chronic, unremitting courses carry a poor prognosis. Delayed, intermittent phenomena ("flashbacks") and LSD-precipitated functional disorders that usually respond to treatment appropriate for the non-psychedelic-precipitated illnesses they resemble, round out this temporal means of classification. The question of organic brain damage as well as permanent changes in personality, attitudes, and creativity in patients and normals who have repeatedly ingested psychedelic drugs is controversial, but tends to point to subtle or nonsignificant changes. Future areas for study of the psychedelics' pharmacological, psychological, and therapeutic effects are suggested.

  10. 40 CFR 717.12 - Significant adverse reactions that must be recorded.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Significant adverse reactions that... SIGNIFICANT ADVERSE REACTIONS TO HEALTH OR THE ENVIRONMENT General Provisions § 717.12 Significant adverse reactions that must be recorded. (a) Except as provided in paragraph (b) of this section, significant...

  11. Patients’ attention to and understanding of adverse drug reaction warnings

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    Tresa Muir McNeal

    2010-12-01

    Full Text Available Tresa Muir McNeal1, Colleen Y Colbert1, Christian Cable1, Curtis R Mirkes1, June G Lubowinski2, John D Myers11Department of Medicine, Texas A&M University System HSC College of Medicine, Scott & White Healthcare, Temple, TX, USA; 2RD Haynes Medical Library, Scott & White Healthcare, Temple, TX, USAIntroduction: Medications are critical to the management of patient conditions, and they can have significant effects on the success or failure of medical interventions. Patient perceptions of drug warnings play an important role in medication compliance and ultimately disease management. Several factors may affect patients’ understanding of drug warnings and drug labeling, including health literacy and interactions with physicians and pharmacists.Purpose: The purpose of this article is to provide a review of the literature related to patient perceptions of drug warnings and drug labeling. Descriptive articles and studies regarding patient perceptions and knowledge of adverse drug reaction warnings were reviewed.Methods: The following databases were utilized to search the literature related to patient perceptions of drug warnings: PubMed, Academic Search Premiere, CINAHL, Medline, Psych Info, Business Source Complete, Alternative Healthwatch, Health Source (both Nursing/Academic and Consumer additions, JSTOR, and Master File Premiere. For the purpose of this review, any peer-reviewed article was eligible. Exclusionary criteria included: articles published in languages other than English, articles/studies on patient perceptions of vaccines and chemotherapy, and articles related to perceptions of medications administered in the inpatient setting. Forty-six articles were included in the review.Results: Health literacy has been shown to have a major impact on patients’ ability to understand potential adverse reactions and instructions on correct dosing of medications. Direct communication with physicians and pharmacists is one of the most important and

  12. [Adverse drug reactions of a slimming product contaminated with sibutramine].

    Science.gov (United States)

    van Hunsel, Florence; van Grootheest, Kees

    2011-01-01

    On the internet numerous diet pills and weight loss courses are advertised. These products may contain active ingredients or contaminants that are not mentioned on the pack or in the patient information leaflet. The Netherlands Pharmacovigilance Centre Lareb received two reports of undesirable effects associated with the unregistered slimming product 'Green Coffee 800'. A 33-year-old woman reported hypomania and a 44-year-old woman reported abnormal hepatic enzyme levels after the use of this product. Research by the Food and Consumer Product Safety Authority revealed that samples of the slimming coffee Green Coffee 800 contained sibutramine. The Dutch Healthcare Inspectorate issued a warning about this product in August 2010. It is plausible that the Green Coffee 800 in the reports sent to Lareb also contained sibutramine. The slimming product Green Coffee 800 may contain sibutramine and may cause severe adverse reactions. This product is still advertised on the Internet.

  13. Adverse drug reaction labelling for atomoxetine, methylphenidate and modafinil

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2013-01-01

    Medical product information contains information about efficacy and safety for marketed pharmaceuticals. Three studies have compared safety labelling for different therapeutic categories in different countries and detected large variations in a number of reported adverse drug reactions (ADRs......). The rapid increase in use of medications for treatment of ADHD symptoms has created concern due to lack of information about effects from long-term use. The aim of this study was to compare ADR information in product information (PI)/summary of product characteristics (SPC) for oral formulations...... information about study design (clinical trials, spontaneous report). Discrepancies in ADR labelling for the medications were found across the three countries. A total of 75 ADR categories were listed for atomoxetine and 80% of these were listed in all three countries. For methylphenidate, totally 101 ADR...

  14. Information about adverse drug reactions reported in children

    DEFF Research Database (Denmark)

    Aagaard, Lise; Christensen, Arne; Hansen, Ebba Holme

    2010-01-01

    AIM: To review the literature on adverse drug reactions (ADRs) in children with respect to occurrence, seriousness, type, therapeutic group, age and gender of the child and category of reporter. METHODS: Medline and Embase databases were searched from origin and updated until February 2010. We...... included empirically based articles on ADRs in populations aged 0 to 17 years. Studies monitoring ADRs in patients with particular conditions or drug exposure were excluded. We extracted information about types and seriousness of ADRs, therapeutic groups, age and gender of the child and category...... inpatients and outpatients. However, prevalence and incidence were much lower in the national databases. Types of reported ADRs, seriousness of ADRs and types of medicines differed substantially between studies due to differences in time periods and patient populations. Information about ADRs was mainly...

  15. Pharmacovigilance: pharmacists’ perspective on spontaneous adverse drug reaction reporting

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    Hadi MA

    2017-03-01

    Full Text Available Muhammad Abdul Hadi,1 Chin Fen Neoh,2 Rosdi M Zin,3 Mahmoud E Elrggal,4 Ejaz Cheema4 1School of Healthcare, Faculty of Medicine and Health, University of Leeds, Leeds, UK; 2Collaborative Drug Discovery Research Group, Faculty of Pharmacy, Universiti Teknologi MARA, Puncak Alam, Salangor, 3Pharmacy Department, Malacca Hospital, Malacca, Malaysia; 4Faculty of Pharmacy, Umm-Al-Qura University, Makkah, Saudi Arabia Abstract: Globally, adverse drug reactions (ADRs, one of the leading causes of morbidity and mortality, will continue to pose a threat to public health as long as drugs are being used to treat various ailments. Prompt ADR reporting is crucial in ensuring drug safety. The aim of this narrative review was to highlight the role of pharmacists in pharmacovigilance and to identify barriers and facilitators toward ADR reporting documented in the literature. The perspective of pharmacy students on pharmacovigilance and ADR reporting has also been discussed with an aim to highlight the need to improve content related to ADR reporting and pharmacovigilance in undergraduate pharmacy curriculum. Globally, although the role of pharmacists within national pharmacovigilance systems varies, it is very well recognized. In general, pharmacists acknowledge that ADR reporting is part of their professional responsibility and have a positive attitude toward reporting ADRs. However, current research evidence suggests that there are still critical knowledge gaps with regard to ADR reporting among pharmacists, especially in countries where the role of pharmacists within the health care system is limited. These knowledge gaps can be fulfilled through continuous professional development programs and reinforcing theoretical and practical knowledge in undergraduate pharmacy curriculums. Without adequately identifying and fulfilling training needs of pharmacists and other health care professionals, the efficiency of national pharmacovigilance systems is unlikely to

  16. Adverse drug reactions in children--a systematic review.

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    Rebecca Mary Diane Smyth

    Full Text Available Adverse drug reactions in children are an important public health problem. We have undertaken a systematic review of observational studies in children in three settings: causing admission to hospital, occurring during hospital stay and occurring in the community. We were particularly interested in understanding how ADRs might be better detected, assessed and avoided.We searched nineteen electronic databases using a comprehensive search strategy. In total, 102 studies were included. The primary outcome was any clinical event described as an adverse drug reaction to one or more drugs. Additional information relating to the ADR was collected: associated drug classification; clinical presentation; associated risk factors; methods used for assessing causality, severity, and avoidability. Seventy one percent (72/102 of studies assessed causality, and thirty four percent (34/102 performed a severity assessment. Only nineteen studies (19% assessed avoidability. Incidence rates for ADRs causing hospital admission ranged from 0.4% to 10.3% of all children (pooled estimate of 2.9% (2.6%, 3.1% and from 0.6% to 16.8% of all children exposed to a drug during hospital stay. Anti-infectives and anti-epileptics were the most frequently reported therapeutic class associated with ADRs in children admitted to hospital (17 studies; 12 studies respectively and children in hospital (24 studies; 14 studies respectively, while anti-infectives and non-steroidal anti-inflammatory drugs (NSAIDs were frequently reported as associated with ADRs in outpatient children (13 studies; 6 studies respectively. Fourteen studies reported rates ranging from 7%-98% of ADRs being either definitely/possibly avoidable.There is extensive literature which investigates ADRs in children. Although these studies provide estimates of incidence in different settings and some indication of the therapeutic classes most frequently associated with ADRs, further work is needed to address how such ADRs

  17. [Adverse drug reactions in patients attending in emergency service].

    Science.gov (United States)

    Machado-Alba, Jorge E; Moncada-Escobar, Juan C

    2006-01-01

    Describing adverse drug reactions (ADR) and analyzing the factors associated with their appearance in patients attending two hospitals' emergency services. Descriptive, medicine-surveillance study of people consulting the emergency service at the Rosales hospital and the basic total health attention unit in Pereira, Colombia, between July and September 2005 for any symptom related to taking medicine. Naranjo's Adverse Drug Reaction probability scale was used. A total of 91 patients were found; 62,6 % were women having an average age of 36,3+/-22,4 (range 0-85). Antibiotics (24,2 %) NSAIDs (17,6 %), analgesics (9,9 %) and antidiabetic agents (8,8 %) were the most used drugs. 39,6 % of the patients only used one medicine; the average of drugs per patient was 2,4+/-1,5. Self-medication was present in 25,3 %. The most common ADRs arose from urticaria (31,9 %), hypoglycaemia (8,8 %), gastritis (6,6 %), angioedema (5,5 %) and anaphylaxis (4,4 %). 13,2 % of ADRs were serious and 54,9 % were avoidable. 14,3 % of ADRs were classified as being definite and 75,8 % probable. Only 14,3 % of patients had a past history of ADR. The average cost of being attended was US$ 78,1 dollars. Analgesic use was associated with anaphylaxis, antibiotics with urticaria whilst NSAIDs was associated with gastritis and gastrointestinal bleeding, antidiabetic agents with hypoglycaemia, antipsychotic and antidepressants agents with neurological symptoms and warfarin with bleeding. The most important ADR-associated risk factors in patients attending emergency services were determined. Special care must be paid to patients using NSAIDs, warfarin, metoclopramide, metamizole, antipsychotic and antidepressants agents, antidiabetic agents and antibiotics, having a past history of ADR, being more than 55 years old and presenting urticaria, digestive and/or neurological symptoms

  18. The evolution of prompt reaction to adverse ties.

    Science.gov (United States)

    Van Segbroeck, Sven; Santos, Francisco C; Nowé, Ann; Pacheco, Jorge M; Lenaerts, Tom

    2008-10-17

    In recent years it has been found that the combination of evolutionary game theory with population structures modelled in terms of dynamical graphs, in which individuals are allowed to sever unwanted social ties while keeping the good ones, provides a viable solution to the conundrum of cooperation. It is well known that in reality individuals respond differently to disadvantageous interactions. Yet, the evolutionary mechanism determining the individuals' willingness to sever unfavourable ties remains unclear. We introduce a novel way of thinking about the joint evolution of cooperation and social contacts. The struggle for survival between cooperators and defectors leads to an arms race for swiftness in adjusting social ties, based purely on a self-regarding, individual judgement. Since defectors are never able to establish social ties under mutual agreement, they break adverse ties more rapidly than cooperators, who tend to evolve stable and long-term relations. Ironically, defectors' constant search for partners to exploit leads to heterogeneous networks that improve the survivability of cooperators, compared to the traditional homogenous population assumption. When communities face the prisoner's dilemma, swift reaction to adverse ties evolves when competition is fierce between cooperators and defectors, providing an evolutionary basis for the necessity of individuals to adjust their social ties. Our results show how our innate resilience to change relates to mutual agreement between cooperators and how "loyalty" or persistent social ties bring along an evolutionary disadvantage, both from an individual and group perspective.

  19. Active surveillance of visual impairment due to adverse drug reactions: findings from a national study in the United Kingdom.

    Science.gov (United States)

    Cumberland, Phillippa M; Russell-Eggitt, Isabelle; Rahi, Jugnoo S

    2015-02-01

    As visual impairment (VI) due to adverse drug reactions (ADR) is rare in adults and children, there is an incomplete evidence base to inform guidance for screening and for counseling patients on the potential risks of medications. We report on suspected drugs and the eye conditions found in a national study of incidence of diagnosis of visual impairment due to suspected ADR. Case ascertainment was via the British Ophthalmological Surveillance Unit (BOSU), between March 2010 and February 2012, with follow-up after 6 months. any child or adult with bilateral or unilateral visual impairment due to a suspected ADR, using distance acuity worse than Snellen 6/18 (logMAR 0.48) in the better eye (bilateral) or affected eye (unilateral). Anonymized patient information on potential cases was provided by managing ophthalmologists, comprising visual status before and after suspected ADR, ophthalmic condition attributable to the ADR, preexisting eye disease and prescribed medications at the time of the ADR. Permanency and causality of the visual impairment were confirmed by the managing clinician, after 6 months, using the WHO Uppsala Monitoring Committee criteria. Over 2 years, 36 eligible cases were reported of whom 23 had permanent VI. While most cases were due to drugs known to have adverse side-effects, some were unanticipated sporadic cases. Visual impairment due to ADRs is rare. However, with for example, increasing polypharmacy in the elderly, monitoring of ocular ADRs, although challenging, is necessary.

  20. Campania preventability assessment committee: a focus on the preventability of the contrast media adverse drug reactions.

    Science.gov (United States)

    Sessa, Maurizio; Rossi, Claudia; Rafaniello, Concetta; Mascolo, Annamaria; Cimmaruta, Daniela; Scavone, Cristina; Fiorentino, Sonia; Grassi, Enrico; Reginelli, Alfonso; Rotondo, Antonio; Sportiello, Liberata

    2016-12-01

    The current study aims to assess the preventability of the contrast media adverse drug reactions reported through the Campania spontaneous reporting system, identifying the possible limitations emerged in this type of evaluation. All the individual case safety reports validated by the Campania Pharmacovigilance Regional Centre from July 2012 to September 2015 were screened to select those that reported contrast media as suspected drug. Campania Preventability Assessment Committee, in collaboration with clinicians specialized in Radiology, assessed the preventability according to the P-Method, through a case-by-case approach. From July 2012 to September 2015, 13798 cases were inserted by pharmacovigilance managers in the Italian Pharmacovigilance Network database (in the geographical contest of the Campania Region), of which 67 reported contrast media as suspected drug. Five preventable cases were found. The most reported causes for preventability were the inappropriate drug use for the case clinical conditions and the absence of the preventive measure administrated prior to the contrast media administration. Several limitations were found in the evaluation of the critical criteria for the preventability assessment. Educational initiatives will be organized directly to the healthcare professionals involved in the contrast media administration, to promote an appropriate use of the contrast media.

  1. Retrospective evaluation of adverse drug reactions induced by antihypertensive treatment

    Science.gov (United States)

    Rende, Pierandrea; Paletta, Laura; Gallelli, Giuseppe; Raffaele, Gianluca; Natale, Vincenzo; Brissa, Nazareno; Costa, Cinzia; Gratteri, Santo; Giofrè, Chiara; Gallelli, Luca

    2013-01-01

    The use of cardiovascular drugs is related to the development of adverse drug reactions (ADRs) in about 24% of the patients in the Cardiovascular Care Unit. Here, we evaluated the ADRs in patients treated with antihypertensive drugs. The study was conducted in two phases: In the first phase, we performed a retrospective study on clinical records of Clinical Divisions (i.e., Internal Medicine Operative Unit and Geriatric Operative Unit) from January 1, 2012 to December 31, 2012. Moreover from January 1, 2013 to March 30, 2013 we performed a prospective study on the outpatients attending the Emergency Department (ED) of the Pugliese-Ciaccio Hospital of Catanzaro, by conducting patient interviews after their informed consent was obtained. The association between a drug and ADR was evaluated using the Naranjo scale. We recorded 72 ADRs in the Clinical Divisions and six in the ED, and these were more frequent in women. Using the Naranjo score, we showed a probable association in 92% of these reactions and a possible association in 8%. The most vulnerable age group involved in ADRs was that of the elderly patients. In conclusion, our results indicate that antihypertensive drugs may be able to induce the development of ADRs, particularly in elderly women receiving multiple drug treatment. Therefore, it is important to motivate the healthcare providers to understand their role and responsibility in the detection, management, documentation, and reporting of ADRs, as also all the essential activities for optimizing patient safety. PMID:24347982

  2. Immunohistopathological Findings of Severe Cutaneous Adverse Drug Reactions

    Directory of Open Access Journals (Sweden)

    Mari Orime

    2017-01-01

    Full Text Available Diagnosis of severe cutaneous adverse drug reactions should involve immunohistopathological examination, which gives insight into the pathomechanisms of these disorders. The characteristic histological findings of erythema multiforme (EM, Stevens–Johnson syndrome (SJS, and toxic epidermal necrolysis (TEN provide conclusive evidence demonstrating that SJS/TEN can be distinguished from EM. Established SJS/TEN shows full-thickness, extensive keratinocyte necrosis that develops into subepidermal bullae. Drug-induced hypersensitivity syndrome (DIHS and exanthema in drug reaction with eosinophilia and systemic symptoms (DRESS each display a variety of histopathological findings, which may partly correlate with the clinical manifestations. Although the histopathology of DRESS is nonspecific, the association of two or more of the four patterns—eczematous changes, interface dermatitis, acute generalized exanthematous pustulosis- (AGEP- like patterns, and EM-like patterns—might appear in a single biopsy specimen, suggesting the diagnosis and severe cutaneous manifestations of DRESS. Cutaneous dendritic cells may be involved in the clinical course. AGEP typically shows spongiform superficial epidermal pustules accompanied with edema of the papillary dermis and abundant mixed perivascular infiltrates. Mutations in IL36RN may have a definite effect on pathological similarities between AGEP and generalized pustular psoriasis.

  3. Sensitization to acrylates is a common adverse reaction to artificial fingernails.

    Science.gov (United States)

    Lazarov, A

    2007-02-01

    Although precise figures for adverse reactions to nail-care products are not available, it is thought that one of the main risks from artificial nails (ANs) is contact allergy. To evaluate the role of allergic contact dermatitis (ACD) as a cause of adverse reactions related to the use of ANs. A 4-year retrospective study of patients with suspected ACD from ANs was conducted. Patients tested with the methacrylate artificial nail (MAAN) series were evaluated clinically and patch test results were analysed. ACD to components of ANs may be a frequent cause of hand eczema, as observed in more than one-third of our patients (38.2%). About half of the patients were beauticians specializing in nail sculpturing who developed occupationally related ACD. All patients had involvement of the hands and fingers. Paronychia, nail dystrophy and onycholysis were less frequent. Dorsal hands and fingers, forearms and distant sites (face and neck) were more frequently affected in patients with occupational ACD (OACD). Typical clinical features were those of chronic dermatitis but atypical forms such as lichenoid and psoriasiform ACD were also observed. Mucosal erythema and oedema developed in two patients with ACD due to MAAN, after application of dental crowns with an acrylate-based cement. The most frequent allergens triggering ACD were 2-hydroxyethyl methacrylate (2-HEMA) and 2-hydroxypropyl methacrylate (2-HPMA) (17.5% each), followed by ethyleneglycol dimethacrylate (EGDM; 13.4%). A quarter of the patients tested with ethyl cyanoacrylate (ECA), a component of nail glue, had positive results. Acrylic monomers used when sculpturing ANs are important contact and occupational sensitizers that can produce cross-reactions with other acrylic compounds and trigger allergic reactions when re-exposure occurs in a different setting.

  4. Cutaneous adverse drug reactions in Indian population: A systematic review

    Directory of Open Access Journals (Sweden)

    Tejas K Patel

    2014-01-01

    Full Text Available Background: Epidemiological data is limited for cutaneous adverse drug reactions (CADRs in India. Most of the Indian studies have small sample size and are of limited duration. Aims: The aim of this study is to analyze CADRs with reference to the causative drugs and their clinical characteristics in Indian population. Materials and Methods: As per selection criteria, electronic databases were searched for publications describing CADRs from January-1995 to April-2013 by two independent investigators. Data of the causative drugs and clinical characteristics were extracted and summarized by absolute numbers, percentages, ranges, and means as presented by the authors. The subgroup analysis of causative drugs was performed for causality assessment, severe or nonsevere reactions and occurrence of common CADRs. Studies showing "definite" and "probable" categories of causality analysis were labeled as "definite and probable causality (DPC studies". The other included studies were labeled as "non-DPC studies". Results: Of 8337 retrieved references, 18 prospective studies were selected for analysis. The pooled incidence was 9.22/1000 total among outpatient and inpatient cases. Commonly observed reactions were maculopapular rash (32.39%, fixed drug eruptions (FDEs (20.13%, urticaria (17.49% and Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN (6.84%. The major causative drug groups were antimicrobials (45.46%, nonsteroidal anti-inflammatory drugs (NSAIDs (20.87% and anti-epileptic drugs (14.57%. Commonly implicated drugs were sulfa (13.32%, β-lactams (8.96% and carbamazepine (6.65%. High frequency of CADRs is observed with anti-epileptic drugs in DPC studies only. Carbamazepine, phenytoin and fluoroquinolones had higher severe to nonsevere cutaneous reaction ratio than other drugs. Antimicrobials were the main causative drugs for maculopapular rash, FDEs and SJS/TEN, and NSAIDs for the urticaria. The mortality for overall CADRs, SJS/TEN, and

  5. Can the reporting of adverse skin reactions to cosmetics be improved? A prospective clinical study using a structured protocol.

    Science.gov (United States)

    Berne, Berit; Tammela, Monica; Färm, Gunilla; Inerot, Annica; Lindberg, Magnus

    2008-04-01

    The use of cosmetics is rising, and adverse reactions to these products are increasing. In Sweden, the Medical Products Agency (MPA) keeps a voluntary reporting system for such adverse reactions. However, the reporting is sparse, consisting almost only of cases with test-proven allergic contact dermatitis, thus under-reporting the more common irritant reactions. The aim of the study was to try to improve the reporting system. Dermatologists at 3 dermatology departments used a structured protocol during the clinical investigation of 151 consecutive patients reporting skin reactions to cosmetics. The protocol included symptoms, signs, affected body site, suspected products, and final diagnosis after patch testing. Based on clinical data and patch test results, a causality assessment for each product was made according to a protocol used at the MPA. Allergic contact dermatitis was found in 28% of the patients, and irritant reactions were equally common at 27%. Using this structured protocol, the cases of irritant dermatitis were also reported, and it is recommended that such a protocol is used as a standard to improve the reporting of adverse reactions to skin care products.

  6. ["Re-evaluation upon suspected event" is an approach for post-marketing clinical study: lessons from adverse drug events related to Bupleuri Radix preparations].

    Science.gov (United States)

    Wu, Shu-Xin; Sun, Hong-Feng; Yang, Xiao-Hui; Long, Hong-Zhu; Ye, Zu-Guang; Ji, Shao-Liang; Zhang, Li

    2014-08-01

    We revisited the "Xiao Chaihu Decoction event (XCHDE)" occurred in late 1980s in Japan and the Bupleuri Radix related adverse drug reaction (ADR) reports in China After careful review, comparison, analysis and evaluation, we think the interstitial pneumonitis, drug induced Liver injury (DILI) and other severe adverse drug envents (ADEs) including death happened in Japan is probably results from multiple factors, including combinatory use of XCHDE with interferon, Kampo usage under modern medicine theory guidance, and use of XCHD on the basis of disease diagnosis instead of traditional Chinese syndrome complex differentiation. There are less ADE case reports related to XCHD preparation in China compared to Japan, mostly manifest with hypersensitivity responses of skin and perfuse perspiration. The symptoms of Radix Bupleuri injection related ADEs mainly manifest hypersensitivity-like response, 2 cases of intravenous infusion instead of intramuscular injection developed hypokalemia and renal failure. One case died from severe hypersensitivity shock. In Chinese literatures, there is no report of the interstitial pneumonitis and DILI associated with XCHDG in Japan. So far, there is no voluntary monitoring data and large sample clinical research data available. The author elaborated the classification of "reevaluation" and clarified "re-evaluation upon events" included the reaction to the suspected safety and efficacy events. Based on the current status of the clinical research on the Radix Bupleuri preparations, the author points out that post-marketing "re-evaluation upon suspected event" is not only a necessity of continuous evaluation of the safety, efficacy of drugs, it is also a necessity for providing objective clinical research data to share with the international and domestic drug administrations in the risk-benefit evaluation. It is also the unavoidable pathway to culture and push the excellent species and famous brands of TCM to the international market, in

  7. Toward multimodal signal detection of adverse drug reactions.

    Science.gov (United States)

    Harpaz, Rave; DuMouchel, William; Schuemie, Martijn; Bodenreider, Olivier; Friedman, Carol; Horvitz, Eric; Ripple, Anna; Sorbello, Alfred; White, Ryen W; Winnenburg, Rainer; Shah, Nigam H

    2017-12-01

    Improving mechanisms to detect adverse drug reactions (ADRs) is key to strengthening post-marketing drug safety surveillance. Signal detection is presently unimodal, relying on a single information source. Multimodal signal detection is based on jointly analyzing multiple information sources. Building on, and expanding the work done in prior studies, the aim of the article is to further research on multimodal signal detection, explore its potential benefits, and propose methods for its construction and evaluation. Four data sources are investigated; FDA's adverse event reporting system, insurance claims, the MEDLINE citation database, and the logs of major Web search engines. Published methods are used to generate and combine signals from each data source. Two distinct reference benchmarks corresponding to well-established and recently labeled ADRs respectively are used to evaluate the performance of multimodal signal detection in terms of area under the ROC curve (AUC) and lead-time-to-detection, with the latter relative to labeling revision dates. Limited to our reference benchmarks, multimodal signal detection provides AUC improvements ranging from 0.04 to 0.09 based on a widely used evaluation benchmark, and a comparative added lead-time of 7-22 months relative to labeling revision dates from a time-indexed benchmark. The results support the notion that utilizing and jointly analyzing multiple data sources may lead to improved signal detection. Given certain data and benchmark limitations, the early stage of development, and the complexity of ADRs, it is currently not possible to make definitive statements about the ultimate utility of the concept. Continued development of multimodal signal detection requires a deeper understanding the data sources used, additional benchmarks, and further research on methods to generate and synthesize signals. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Abnormal T2 mapping cardiovascular magnetic resonance correlates with adverse clinical outcome in patients with suspected acute myocarditis.

    Science.gov (United States)

    Spieker, Maximilian; Haberkorn, Sebastian; Gastl, Mareike; Behm, Patrick; Katsianos, Stratis; Horn, Patrick; Jacoby, Christoph; Schnackenburg, Bernhard; Reinecke, Petra; Kelm, Malte; Westenfeld, Ralf; Bönner, Florian

    2017-03-29

    While most patients recover from suspected acute myocarditis (sAMC) some develop progressive disease with 5-year mortality up to 20%. Recently, parametric Cardiovascular Magnetic Resonance (CMR) approaches, quantifying native T1 and T2 relaxation time, have demonstrated the ability to increase diagnostic accuracy. However, prognostic implications of T2 values in this cohort are unknown. The purpose of the study was to investigate the prognostic relevance of elevated CMR T2 values in patients with sAMC. We carried out a prospective study in 46 patients with sAMC defined by current ESC recommendations. A combined endpoint was defined by the occurrence of at least one major adverse cardiac event (MACE) and hospitalisation for heart failure. Event rate was 24% (n = 11) for 1-year-MACE and hospitalisation. A follow-up after 11 ± 7 months was performed in 98% of the patients. Global T2 values were significantly increased at acute stage of disease compared to controls and decreased over time. During acute disease, elevated global T2 time (odds ratio 6.3, p 80 ms (odds ratio 4.9, p myocarditis. T2 Mapping may emerge as a new tool to monitor inflammatory myocardial injuries during the course of disease.

  9. Monitoring of NSAIDs adverse effects based on spontaneous reports from Wrocław regional adverse drug reactions monitoring center.

    Science.gov (United States)

    Jaźwińska-Tarnawska, Ewa; Wiela-Hojeńska, Anna; Wolańczyk-Medrala, Anna; Patkowski, Janusz; Nittner-Marszalska, Marita; Głowacka, Krystyna

    2012-01-01

    The mechanism of action of non-steroidal anti-inflammatory drugs (NSAIDs) in majority of cases is responsible for adverse reactions of these therapeutic agents. Obtaining post-registration information on adverse drug reactions (ADRs) by means of the Yellow Card System is a significant element in the process of enhancing the safety of pharmacotherapy. The aim of the study was to analyze ADRs of NSAIDs (anti-inflammatory and analgesic drugs) reported to the Regional Centre for the Monitoring of Adverse Drug Reactions (RCMADR) in Wrocław in the years 2007-2009. The study material included 232 spontaneous reports, which were sent by physicians and pharmacists to the RCMADR in Wrocław, out of which 80 concerned mentioned drugs. Analysis of the obtained data revealed a relationship between the incidence and kind of ADRs and the age, gender of the patients, centre from which the data were supplied, geographical region of administered medication. A significant role of post-registration monitoring of adverse drug reactions during therapy with antiinflammatory and analgesic drugs was confirmed in view of geographically conditioned differences affecting the profile of instituted therapy and the source of information. With an increasing global use of these medications, only thorough monitoring of every adverse reaction, encouraging spontaneous reports, as well as analysis at a global level may increase the knowledge on adverse drug reactions and enable correction of the safety profile of every drug from this group.

  10. A prospective survey of delayed adverse reactions to iohexol in urography and computed tomography

    Energy Technology Data Exchange (ETDEWEB)

    Munechika, Hirotsugu [Department of Radiology, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawaku, Tokyo 142-8555 (Japan); Hiramatsu, Yoshihiro [Second Department of Radiology, Toho University School of Medicine, 5-21-16 Omorinishi, Otaku, Tokyo 143-8541 (Japan); Kudo, Sho [Department of Radiology, Saga Medical School, 5-1-1 Nabeshima, Saga City 849-8501 (Japan); Sugimura, Kazuro [Department of Radiology, Kobe University School of Medicine, 7-5-1 Kusunokicho, Chuoku, Kobe City 650-0017 (Japan); Hamada, Chikuma [Department of Pharmacoepidemiology, School of Public Health, Kyoto University, Sakyo-ku, Kyoto 606-8501 (Japan); Yamaguchi, Koichi [Yamagata University School of Medicine, 2-2-2 Iidanishi, Yamagata City 990-9585 (Japan); Katayama, Hitoshi [Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyoku, Tokyo 113-8421 (Japan)

    2003-01-01

    We investigated 7505 inpatients who underwent intravenous urography or contrast-enhanced computed tomography to assess risk factors for delayed adverse drug reactions to iohexol, a non-ionic iodinated contrast medium. Focusing on delayed adverse reactions, all adverse events were prospectively investigated for 7 days after injection of iohexol. To explore the relevant risk factors, the relationship between occurrence of adverse reactions to iohexol and 17 different variables was evaluated by logistic regression analysis. To assess the influence of seasonal factors, adverse reactions were separately evaluated during two periods: February to April (the pollinosis period in Japan) and July to September (the non-pollinosis period). The prevalence of delayed adverse events and delayed adverse reactions was 3.5 and 2.8%, respectively, whereas the prevalence of adverse events and adverse reactions was 5.7 and 5.0%, respectively. Multivariate analysis showed that six parameters had a significant influence on delayed adverse reactions to iohexol, including (a) a history of allergy, (b) season, (c) radiographic procedure, (d) age, (e) concomitant surgery or other invasive procedures, and (f) concomitant medication. The prevalence of delayed reactions was lower than in previous large-scale studies. Significant risk factors included a history of allergy and performance of radiography during the pollinosis period, suggesting that allergy was involved in delayed adverse reactions. The type of radiographic procedure also had an influence. (orig.)

  11. [Adverse reactions to human papillomavirus vaccine in the Valencian Community (2007-2011)].

    Science.gov (United States)

    Rodríguez-Galán, M A; Pérez-Vilar, S; Díez-Domingo, J; Tuells, J; Gomar-Fayos, J; Morales-Olivas, F; Pastor-Villalba, E

    2014-11-01

    In 2009, two cases of seizures in adolescents following quadrivalent human papillomavirus vaccine (qHPV) administration, generated important media attention, and adversely affected public trust in this vaccine. Our objectives were to describe suspected adverse reactions (SARs) reported to the Pharmacovigilance Centre in the Valencian Community (PCVC) after administration of HPV vaccine, and to compare reporting rates of syncope and seizures following this vaccine with those of other vaccines administered to girls aged 13-15 years. Descriptive study of SARs reported following this vaccine to the PCVC between 2007 and 2011. The clinical symptoms most frequently reported were dizziness, headache, and syncope. Reporting rates of syncope or loss of consciousness and seizures with qHPV vaccine were 17 and 3.2 per 100,000 doses administered, respectively, and 15 and 1.6 for syncope or loss of consciousness and syncopal seizures occurred on the day of vaccination. The reporting rates of syncope or loss of consciousness and seizures were 6.4 and 0.4, for the other vaccines. Consistent with the media attention generated, and with results from other studies, the reporting rates of syncope or loss of consciousness and seizures were higher for the HPV vaccine than for other vaccines given in adolescence. Nevertheless, the overall information obtained on SARs following the qHPV vaccine suggests a good safety profile. Copyright © 2013 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

  12. Feature Engineering for Recognizing Adverse Drug Reactions from Twitter Posts

    Directory of Open Access Journals (Sweden)

    Hong-Jie Dai

    2016-05-01

    Full Text Available Social media platforms are emerging digital communication channels that provide an easy way for common people to share their health and medication experiences online. With more people discussing their health information online publicly, social media platforms present a rich source of information for exploring adverse drug reactions (ADRs. ADRs are major public health problems that result in deaths and hospitalizations of millions of people. Unfortunately, not all ADRs are identified before a drug is made available in the market. In this study, an ADR event monitoring system is developed which can recognize ADR mentions from a tweet and classify its assertion. We explored several entity recognition features, feature conjunctions, and feature selection and analyzed their characteristics and impacts on the recognition of ADRs, which have never been studied previously. The results demonstrate that the entity recognition performance for ADR can achieve an F-score of 0.562 on the PSB Social Media Mining shared task dataset, which outperforms the partial-matching-based method by 0.122. After feature selection, the F-score can be further improved by 0.026. This novel technique of text mining utilizing shared online social media data will open an array of opportunities for researchers to explore various health related issues.

  13. Consideration of Adverse Reaction to MDCT Contrast Media

    Energy Technology Data Exchange (ETDEWEB)

    Yang, Won Seok; Shin, Seong Gyu [Dept. of Radiology, Dong A University Medical Center, Busan (Korea, Republic of)

    2012-03-15

    In this experiment, we investigated 82 patients who suffered adverse reactions due to contrast medium. We selected the subjects out of 21,178 people who had an intravenous injection of contrast medium to undergo MDCT examination at one university hospital in Busan in 2007. As a result, the largest groups of the patients were as follows. 52.4% of the patients were male when classify by gender; 28.0% of the patients were 50's by age; 45% of the patients got when it was spring(April and March); 75.6% of the patients had a side effects when the speed of injection is 2.5 mL/sec; 58.5% of the patients were suffered when the volume of injected contrast medium is over 130 mL. Urticaria was the main symptom of side effect as 26.8%. And the main treatment for the effect was alleviating the symptoms before making patients to return home. Thus, practical preventive measures are needed as follows: use the OCS system to observe warning signs at risky patients, secure warming spaces for patients to cope with season changing, prepare enough emergency kits for the patients in danger, and establish CPR call systems, explain the risk of contrast medium and get agree about using contrast medium.

  14. Pharmacovigilance on Twitter? Mining Tweets for Adverse Drug Reactions

    Science.gov (United States)

    O’Connor, Karen; Pimpalkhute, Pranoti; Nikfarjam, Azadeh; Ginn, Rachel; Smith, Karen L; Gonzalez, Graciela

    2014-01-01

    Recent research has shown that Twitter data analytics can have broad implications on public health research. However, its value for pharmacovigilance has been scantly studied – with health related forums and community support groups preferred for the task. We present a systematic study of tweets collected for 74 drugs to assess their value as sources of potential signals for adverse drug reactions (ADRs). We created an annotated corpus of 10,822 tweets. Each tweet was annotated for the presence or absence of ADR mentions, with the span and Unified Medical Language System (UMLS) concept ID noted for each ADR present. Using Cohen’s kappa1, we calculated the inter-annotator agreement (IAA) for the binary annotations to be 0.69. To demonstrate the utility of the corpus, we attempted a lexicon-based approach for concept extraction, with promising success (54.1% precision, 62.1% recall, and 57.8% F-measure). A subset of the corpus is freely available at: http://diego.asu.edu/downloads. PMID:25954400

  15. Adverse Drug Reactions: Knowledge, Attitude and Practice of Pharmacy

    Directory of Open Access Journals (Sweden)

    Maryam Etminani-Isfahani

    2015-10-01

    Full Text Available Background: Adverse Drug Reactions (ADRs are one of the leading causes of morbidity and mortality and contribute to excessive health care costs. Detection and reporting of ADRs could decrease these consequences. The present study was designed to assess the Knowledge, Attitude and Practice (KAP of pharmacy students towards ADRs monitoring and reporting.Methods: A questionnaire was prepared to investigate the Knowledge, Attitude and Practice (KAP of pharmacy students regarding ADR reporting. The questionnaire consisting of 17 questions (7 questions on knowledge, 5 on attitudes and 5 on practice were given to pharmacy students randomly.Results: A total of 71 respondents participated in the study. 70% of participants had favorable general knowledge about ADRs but more than 60% of their professional knowledge was not satisfying. 60% of respondent believed that educational intervention will improve participating of health care professional in ADRs reporting. 63% of respondent observed ADRs cases but about 95% of them had never reported an ADR.Conclusion: In overall, pharmacy students have poor knowledge, attitude and practice towards ADRs reporting and pharmacovigilance. This suggests the need of suitable changes in the undergraduate teaching curriculum and additional training among the students regarding ADRs.

  16. Adverse drug reactions associated with asthma medications in children

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2014-01-01

    Background Respiratory medications are frequently prescribed for use in children. Several studies have reported information on the safety of asthma medications in clinical studies in adults, but information about safety in children is scarce. Objective To review published clinical trials on the o......Background Respiratory medications are frequently prescribed for use in children. Several studies have reported information on the safety of asthma medications in clinical studies in adults, but information about safety in children is scarce. Objective To review published clinical trials...... on the occurrence and characteristics of adverse drug reactions (ADRs) in children, reported for asthma medications licensed for paediatric use. Methods We systematically reviewed the literature following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement guidelines. PubMed, Embase...... as they reported information about ADR rates from use of salmeterol, formoterol, fluticasone, montelukast, zafirlukast and budesonide/formoterol in children. The total population was approximately 3,000 children; the majority was 6- to 11-year-olds and two thirds of these were boys. The observation period varied...

  17. Pharmacovigilance in pregnancy: adverse drug reactions associated with fetal disorders.

    Science.gov (United States)

    Wettach, Carmen; Thomann, Janine; Lambrigger-Steiner, Claudia; Buclin, Thierry; Desmeules, Jules; von Mandach, Ursula

    2013-05-01

    To provide the first update on drug safety profiles and adverse drug reactions (ADRs) associated with fetal disorders from the Swiss national ADR database. We conducted a retrospective study using data from 202 pharmacovigilance reports on drug-associated fetal disorders from the Swiss national ADR database from 1990 to 2009. Evaluated aspects included administrative information on the report, drug exposure, and disorders. The ADR reporting frequency on the topic of fetal disorders has increased during the last 20 years, from only 1 report in 1991 to a maximum of 31 reports in 2008. Nervous system drugs were the most frequently reported drug group (40.2%) above all antidepressants and antiepileptics. The highest level of overall drug intake could be observed for the 1st trimester (85.4%), especially for the first 6 weeks of pregnancy. The most frequently reported types of fetal disorders were malformations (68.8%), especially those of the musculoskeletal and circulatory systems. A positive association was discovered between antiepileptics and malformations in general and in particular of the circulatory system and the eye, ear, face, and neck. The results suggest that the nervous system drug group bears an especially high risk for malformations. The most commonly identified drug exposures can help focus pharmacoepidemiologic efforts in drug-induced birth defects.

  18. Clinical and economic burden of adverse drug reactions.

    Science.gov (United States)

    Sultana, Janet; Cutroneo, Paola; Trifirò, Gianluca

    2013-12-01

    Adverse drug reactions (ADRs) are unwanted drug effects that have considerable economic as well as clinical costs as they often lead to hospital admission, prolongation of hospital stay and emergency department visits. Randomized controlled trials (RCTs) are the main premarketing methods used to detect and quantify ADRs but these have several limitations, such as limited study sample size and limited heterogeneity due to the exclusion of the frailest patients. In addition, ADRs due to inappropriate medication use occur often in the real world of clinical practice but not in RCTs. Postmarketing drug safety monitoring through pharmacovigilance activities, including mining of spontaneous reporting and carrying out observational prospective cohort or retrospective database studies, allow longer follow-up periods of patients with a much wider range of characteristics, providing valuable means for ADR detection, quantification and where possible reduction, reducing healthcare costs in the process. Overall, pharmacovigilance is aimed at identifying drug safety signals as early as possible, thus minimizing potential clinical and economic consequences of ADRs. The goal of this review is to explore the epidemiology and the costs of ADRs in routine care.

  19. Testing an explanatory model of nurses' intention to report adverse drug reactions in hospital settings.

    Science.gov (United States)

    Angelis, Alessia De; Pancani, Luca; Steca, Patrizia; Colaceci, Sofia; Giusti, Angela; Tibaldi, Laura; Alvaro, Rosaria; Ausili, Davide; Vellone, Ercole

    2017-05-01

    To test an explanatory model of nurses' intention to report adverse drug reactions in hospital settings, based on the theory of planned behaviour. Under-reporting of adverse drug reactions is an important problem among nurses. A cross-sectional design was used. Data were collected with the adverse drug reporting nurses' questionnaire. Confirmatory factor analysis was performed to test the factor validity of the adverse drug reporting nurses' questionnaire, and structural equation modelling was used to test the explanatory model. The convenience sample comprised 500 Italian hospital nurses (mean age = 43.52). Confirmatory factor analysis supported the factor validity of the adverse drug reporting nurses' questionnaire. The structural equation modelling showed a good fit with the data. Nurses' intention to report adverse drug reactions was significantly predicted by attitudes, subjective norms and perceived behavioural control (R² = 0.16). The theory of planned behaviour effectively explained the mechanisms behind nurses' intention to report adverse drug reactions, showing how several factors come into play. In a scenario of organisational empowerment towards adverse drug reaction reporting, the major predictors of the intention to report are support for the decision to report adverse drug reactions from other health care practitioners, perceptions about the value of adverse drug reaction reporting and nurses' favourable self-assessment of their adverse drug reaction reporting skills. © 2017 John Wiley & Sons Ltd.

  20. Usefulness of drug provocation tests in children with a history of adverse drug reaction

    Directory of Open Access Journals (Sweden)

    Hye Ran Na

    2011-07-01

    Full Text Available Purpose : There are very few reports of adverse drug reactions (ADR and almost no study of drug provocation test (DPT in Korean children. We aimed to assess the role of DPT in children with unpredictable ADRs, and compare the causative drugs and clinical characteristics between detailed history of ADRs and result of DPTs. Methods : We included 16 children who were experienced ADRs referred to pediatric allergy clinic at Ajou University Hospital (January 2006 to December 2009. With various suspected drugs, 71 DPTs were done in 16 patients using our own protocol, and skin tests to antibiotics were combined in ADRs to antibiotics in medical history. Results : There were 17 (23.9% positive DPTs results out of 71 individual DPTs, and 11 patients (68.8% from 16 patients were positive to at least one drug. Drugs causing positive reactions were acetaminophen in 5 (31%, Non-steroidal anti-inflammatory drugs in 4 (25%, penicillin in 3 (19%, cephalosporin in 2 (13%, and cotrimoxazole, macrolide and lactose in 1 each. Conclusion : DPT seems a safe and useful procedure to confirm causative drug and identify safely administering alternative drugs in children with ADR.

  1. Adverse reactions induced by NSAIDs and antibacterials: analysis of spontaneous reports from the Sicilian regional database.

    Science.gov (United States)

    Polimeni, Giovanni; Salvo, Francesco; Cutroneo, Paola; Morreale, Ilaria; Patrizio Caputi, Achille

    2006-01-01

    To (i) evaluate the suspected adverse drug reactions (ADRs) related to NSAIDs and antibacterials that were reported to Sicilian local health officers by healthcare professionals; and (ii) to detect new or serious potential signals of alarm related to these two widely used drug categories. We selected all the spontaneous reports of ADRs sent between January 1998 and June 2004 and analysed those attributed to NSAIDs and systemic antibacterials, applying proportional reporting ratio (PRR) methodology. PRRs >2, chi(2) >4 and >3 ADRs were regarded as signals. During the period considered, 1585 reports of ADRs were received overall (42.6% serious), with an annual reporting rate of approximately 49.1 reports per million inhabitants on average; 351 referred to systemic antibacterials, and 179 to NSAIDs. There were 174 (49.6%) reports of serious ADRs associated with antimicrobials and 108 (60.3%) associated with NSAIDs. Disproportionality was observed, in particular for anaphylactic shock induced by ceftriaxone (all reports were associated with off-label use of the drug), photosensitivity reaction induced by lomefloxacin (administered in the summer), hepatitis induced by nimesulide (three cases leading to liver transplantation) and vasculitis induced by nimesulide. Our analysis highlighted several signals of alarm deserving further investigation or measures to influence prescribing. This study underlines the value of a regional centre in identifying local factors (such as prescribing patterns) that may increase the prevalence of serious ADRs.

  2. Establishing an Adverse Drug Reactions Database in Romania: Practical Value

    Directory of Open Access Journals (Sweden)

    Andreea Maria FĂRCAŞ

    2011-06-01

    Full Text Available Objectives: The need to monitor, track, evaluate and proper manage adverse drug reactions (ADRs in the hospital setting has become a fundamental component of the routine clinical practice and of the healthcare system. Computerized systems are used for such data entry, storage and further analysis with the final goal of avoiding ADRs. This paper describes a database designed for this purpose as part of a pharmacovigilance program in Romania. Methods and Setting: Stimulated spontaneous reporting is the method used for the detection of ADRs in two internal medicine departments. The ADRs collection is paper based. The information is further evaluated for various parameters and then the data is entered into the database. In the design of the database we took into consideration some basic requirements for such a database: comfortable user interface with easy access and handling, high level of security, data protection and desired statistics. Results: The database was designed in order to include a complete description of ADRs (e.g. causality, preventability, severity, outcome, type of ADR, risk factors, drug interactions. Auxiliary databases such as ICD-10, ATC codes and the MedDRA terminology are being used. The database has been in operation for a year, during which approximately 250 ADR case reports have been evaluated and entered. Conclusions: To improve and strengthen the ADRs reporting at a hospital level we developed and populated a computer-based system for standardized collection, evaluation and storage of ADRs that could be further adopted by other academic hospitals that want to keep track of preventable ADRs.

  3. Human leukocyte antigen and idiosyncratic adverse drug reactions.

    Science.gov (United States)

    Usui, Toru; Naisbitt, Dean J

    2017-02-01

    A clinical association between a specific human leukocyte antigen (HLA) allele and idiosyncratic adverse drug reactions (IADRs) is a strong indication that IADRs are mediated by the adaptive immune system. For example, it is well-established that HLA-B*15:02 and HLA-B*57:01 are associated with carbamazepine-induced Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and abacavir-induced hypersensitivity/flucloxacillin-induced liver injury, respectively. Drug-specific T-cells whose response is restricted by specific HLA risk alleles have been detected from IADR patients, also suggesting an adaptive immune pathogenesis. T-cells from carbamazepine SJS/TEN patients are activated by direct pharmacological interaction between carbamazepine and HLA-B*15:02 expressed on antigen presenting cells (APCs). Abacavir-specific, HLA-B*57:01-restricted T-cells are activated by APCs presenting peptides which are only displayed by the HLA molecule when abacavir is bound during peptide loading. Finally, HLA-B*57:01-restricted activation of T-cells from patients with flucloxacillin-induced liver injury is dependent on processing of drug protein adducts. Based on these observations, it is now possible to utilize blood from healthy drug-naïve volunteers to study the priming of naïve T-cells to drugs. Future development of these methodologies may lead to the development of assays that predict intrinsic immunogenicity of drugs and chemicals at the preclinical stage of drug development. Copyright © 2016 The Japanese Society for the Study of Xenobiotics. Published by Elsevier Ltd. All rights reserved.

  4. Imputation of adverse drug reactions: Causality assessment in hospitals.

    Science.gov (United States)

    Varallo, Fabiana Rossi; Planeta, Cleopatra S; Herdeiro, Maria Teresa; Mastroianni, Patricia de Carvalho

    2017-01-01

    Different algorithms have been developed to standardize the causality assessment of adverse drug reactions (ADR). Although most share common characteristics, the results of the causality assessment are variable depending on the algorithm used. Therefore, using 10 different algorithms, the study aimed to compare inter-rater and multi-rater agreement for ADR causality assessment and identify the most consistent to hospitals. Using ten causality algorithms, four judges independently assessed the first 44 cases of ADRs reported during the first year of implementation of a risk management service in a medium complexity hospital in the state of Sao Paulo (Brazil). Owing to variations in the terminology used for causality, the equivalent imputation terms were grouped into four categories: definite, probable, possible and unlikely. Inter-rater and multi-rater agreement analysis was performed by calculating the Cohen´s and Light´s kappa coefficients, respectively. None of the algorithms showed 100% reproducibility in the causal imputation. Fair inter-rater and multi-rater agreement was found. Emanuele (1984) and WHO-UMC (2010) algorithms showed a fair rate of agreement between the judges (k = 0.36). Although the ADR causality assessment algorithms were poorly reproducible, our data suggest that WHO-UMC algorithm is the most consistent for imputation in hospitals, since it allows evaluating the quality of the report. However, to improve the ability of assessing the causality using algorithms, it is necessary to include criteria for the evaluation of drug-related problems, which may be related to confounding variables that underestimate the causal association.

  5. Severe cutaneous adverse reactions to antiepileptic drugs in Asians.

    Science.gov (United States)

    Yang, C-Y; Dao, R-L; Lee, T-J; Lu, C-W; Yang, C-H; Hung, S-I; Chung, W-H

    2011-12-06

    Ethnicity has been shown to be a contributing risk factor regarding antiepileptic drug (AED)-induced severe cutaneous adverse drug reactions (SCARs). To increase the clinical and epidemiologic information in Asians, we investigated the characteristics, outcome, and tolerability toward alternative drugs for AED-induced SCARs. A total of 154 patients with AED-induced SCARs, including Stevens-Johnson syndrome (SJS), toxic epidermal necrosis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS), were analyzed for demographic characteristics, causative AEDs, latent period, organ involvement, complications, and mortality. Tolerability toward alternative AEDs was followed for patients after AED-SCARs episodes. Carbamazepine (CBZ) and phenytoin (PHT) were the most common causative AEDs for SJS/TEN (67.8%) and DRESS (43.6%), respectively. No SCARs case was caused by nonaromatic AEDs, e.g., valproic acid (VPA) and topiramate (TPM). The liver was the most frequently involved internal organ in AED-DRESS, whereas ocular complications were more commonly seen in AED-SJS/TEN. The mortality of AED-SJS/TEN and -DRESS was 6.1% and 7.7%, respectively. By following alternative AED usage of patients after AED-SCARs episodes, we noted that most patients were tolerant of nonaromatic AEDs. One case of oxcarbazepine-SJS had cross-hypersensitivity to lamotrigine (LTG) and further developed into DRESS. CBZ, PHT, and LTG were the major causative AEDs for SCARs. The mortality of PHT-SCARs was higher than CBZ-SCARs due to complicated comorbidity in patients. Nonaromatic AEDs were safe alternatives for patients with aromatic AED-induced SCARs.

  6. [Adverse reaction caused by rabies vaccine in China: a Meta-analysis].

    Science.gov (United States)

    Zhang, X R; Wu, Z G; Zhang, W S

    2017-06-10

    Objective: To conduct a Meta-analysis on the rate of adverse reaction related to rabies vaccine, so as to provide reference for rabies vaccine immunization in China. Methods: We electronically searched databases including CNKI, VIP information resource integration service platform, WanFang Data, CBM, PubMed and The Cochrane Library, to collect studies on Chinese people who had received full rabies vaccination and recording all the adverse reactions, from January 2000 to July 2016. Inclusion and exclusion criteria were strictly followed. Meta-analysis for the adverse reaction rate was performed using the R software. Results: A total of 29 related papers had met the inclusion criteria, with no publication bias noticed. A total number of 11 020 cases had adverse reactions, among all the 94 222 respondents, with an incidence of adverse reactions as 1.04 % -47.78 % . The overall incidence rate of adverse reaction was 9.82 % (95 %CI : 7.58 % -12.72 % ). A combined local adverse reaction rate appeared as 12.05 % (95 % CI : 9.26 % -15.69 % ). The systemic adverse reaction rate was 9.06 % (95 %CI : 7.07 % -11.61 % ). The overall adverse reaction rate on aqueous vaccine was 32.39 % (95 %CI : 21.88 % -47.94 % ). Combined adverse reaction rate of freeze dried vaccine appeared as 8.65 % (95 %CI : 4.54 % -16.51 % ). Significant differences were seen between both groups ( P rabies vaccination was higher than the systemic adverse reaction rate. The adverse reaction rate of aqueous rabies vaccine was higher than that of freeze dried rabies vaccine. Our results suggested that the aqueous vaccine should gradually be eliminated.

  7. Drug related medical emergencies in the elderly: role of adverse drug reactions and non-compliance

    OpenAIRE

    Malhotra, S; Karan, R; Pandhi, P; Jain, S

    2001-01-01

    BACKGROUND—Adverse drug reactions and non-compliance are important causes of admissions in the elderly to medical clinics. The contribution of adverse drug reactions and non-compliance to admission by the medical emergency department was analysed.
METHODS—A total of 578 consecutive elderly patients admitted to the medical emergency department were interviewed to determine the percentage of admissions due to adverse drug reactions or non-compliance with medication regimens, their causes, conse...

  8. Neonatal adverse drug reactions: an analysis of reports to the French pharmacovigilance database.

    Science.gov (United States)

    Kaguelidou, Florentia; Beau-Salinas, Frédérique; Jonville-Bera, Annie Pierre; Jacqz-Aigrain, Evelyne

    2016-10-01

    Term and preterm neonates are at high risk for serious adverse drug reactions (ADRs). A descriptive study of reports registered in the French pharmacovigilance database from 1986 to 2012 were obtained. All reports concerning neonates (≤1 month of life) with direct drug exposure were retrieved. Characteristics of the reports, including reported ADR(s), drug(s) and the causality assessment using the French causality assessment method, were described. A total of 1688 reports were analyzed and more than half of them were classified as serious (n = 995). Median age at ADR occurrence was 9 days. Overall, 3127 ADRs were described in these reports in relation to 2238 suspect/interacting drugs. The most commonly reported system organ classes (SOCs) were injury, poisoning and procedural complications (16%), general disorders and administration site conditions (12.5%) and blood and lymphatic system disorders (12%). In the majority of ADRs reported (73%), infants fully recovered and less than 4% of neonates deceased as a consequence of the reported ADR. One out of five ADRs was associated with drug administration errors. Therapeutic classes commonly incriminated were anti-infectives, nervous system and alimentary tract drugs. Substances most frequently related to serious ADRs were zidovudine, ibuprofen and nevirapine. Among the 10 most frequently encountered drug-ADR pairs, two substances were mainly implicated, zidovudine in haematological adverse reactions and phytomenadione in maladministrations. Anti-infective drugs, mainly antiretroviral therapy, account for the majority of ADRs reported in neonates. The specific issue of drug maladministration and medication errors remains to be addressed in neonates. © 2016 The British Pharmacological Society.

  9. Acute Adverse Reactions to Gadopentetate Dimeglumine and Gadobenate Dimeglumine: Experience With 32,659 Injections

    National Research Council Canada - National Science Library

    Abujudeh, Hani H; Kosaraju, Vijaya K; Kaewlai, Rathachai

    2010-01-01

    .... Data from continuous quality assurance records on the number of administrations of and acute adverse reactions to gadopentetate dimeglumine and gadobenate dimeglumine at our institution October 2007...

  10. PROFILE AND RISK FACTORS OF ADVERSE REACTIONS IN NEW TUBERCULOSIS CASES RECEIVING TREATMENT

    OpenAIRE

    D. A. Ivаnovа; S. E. Borisov

    2017-01-01

    In order to evaluate  the frequency  and risk factors of adverse reactions,  the monitoring results  of clinical and laboratory tests  of 435 new cases of respiratory tuberculosis being on the intensive phase of chemotherapy have been analyzed. 95.2% of patients had adverse reactions (95% CI 92.7-96.9); 48.7% demonstrated severe adverse reactions and in 72.7% treatment regimen had to be changed. Regarding the profile of adverse reactions, hepatotoxic ones prevailed (59.3%), they were followed...

  11. Oxidative stress and leukocyte migration inhibition response in cutaneous adverse drug reactions

    Directory of Open Access Journals (Sweden)

    Prashant Verma

    2012-01-01

    Full Text Available Background: Cutaneous adverse drug reactions (CADRs may either be immunological or non-immunological. The precise mechanisms, however, are largely obscure. Other concomitant mechanisms may amplify and/or contribute to the severity and duration of a reaction. One such mechanism could be oxidative stress, a state of imbalance between reactive oxygen species, and their subsequent detoxification by antioxidants. Aims: (a to assess the oxidative stress status in the blood of cutaneous drug reaction patients by assaying for reduced glutathione (GSH and malondialdehyde (MDA levels, (b to determine the leukocyte migration inhibition (LMI response in these patients in response to the suspected drug (s, and (c to look for the association between oxidative stress parameters and LMI. Methods: Ethical committee approval was obtained for this study. Fresh venous blood samples were obtained from the patients of CADRs (group A during the acute phase of reaction and healthy control subjects (group B. MDA levels, a measure of oxidative lipid damage, and reduced GSH levels, a measure of anti-oxidant capacity, were assayed in the blood samples of both groups using spectrophotometry. LMI response was measured by challenging the patients′ peripheral blood mononuclear cells with the suspected drug to confirm immunological perturbation. Results: Totally 66 participants, 33 cases in group A and equal number of controls in group B, were studied. The mean MDA levels were found to be raised (P < 0.001, but GSH levels were significantly reduced in group A when compared with group B (P = <0.001. LMI response against drug(s was performed in 33 cases (group A, out of which 25 cases showed a positive LMI response as follows: fixed drug eruption (10/25, SJS (5/25, urticaria (3/25, exfoliative dermatitis (2/25, morbilliform rash (2/25, erythroderma (1/25, vasculitis (1/25, and dapsone syndrome (1/25. The mean MDA levels were found to be significantly higher in the LMI positive

  12. Transfusion-related adverse reactions in pediatric and surgical patients at a tertiary care teaching hospital in India.

    Science.gov (United States)

    Ghataliya, Kunal J; Kapadia, Jigar D; Desai, Mira K; Mehariya, K M; Rathod, G H; Bhatnagar, Nidhi; Gajjar, M D

    2017-01-01

    Use of blood and its components is lifesaving. However, their use is often associated with adverse events. To analyze the pattern of adverse reactions associated with transfusion of blood and its components in pediatric and surgical patients at a tertiary care teaching hospital. Patients receiving transfusion of blood or its components in a randomly selected unit each from Departments of Pediatrics, including thalassemia OPD and surgery, were monitored intensively for a period of 6 months. Clinical course, management, outcome, causality, severity, seriousness, and preventability of observed transfusion reactions (TRs) were analyzed. A total of 411 pediatric and 433 surgical patients received 594 and 745 transfusions respectively during the study period. Of these, TRs were observed in 69 (11.6%) children and 63 (8.4%) surgical patients. Majority of reactions in children (48, 69.5%) and surgical patients (51, 80.9%) were acute, developing within 24 h of transfusion. TRs were observed with packed cells (13.2%), cryoprecipitate (10%), platelet concentrate (14.3%) and fresh frozen plasma (1.3%) in pediatric patients and with packed cells (7.2%), whole blood (25%) and platelet concentrate (62.5%) in surgical patients. Most common TRs included febrile nonhemolytic TRs (FNHTRs) and allergic reactions. Reactions were more frequent in patients with a previous history of transfusion or those receiving more than one transfusion and in children, when transfusion was initiated after 30 min of issue of blood component. Majority of reactions were managed with symptomatic treatment, were nonserious, moderately severe, probably preventable and probably associated with the suspect blood component in both populations. Transfusion reactions in children and surgical patients are commonly observed with cellular blood components. Majority of reactions are acute and nonserious. FNHTRs and allergic reactions are the most common transfusion reactions. Risk of transfusion reactions is more in

  13. Critically appraised topic on adverse food reactions of companion animals (3): prevalence of cutaneous adverse food reactions in dogs and cats.

    Science.gov (United States)

    Olivry, Thierry; Mueller, Ralf S

    2017-02-15

    The prevalence of cutaneous adverse food reactions (CAFRs) in dogs and cats is not precisely known. This imprecision is likely due to the various populations that had been studied. Our objectives were to systematically review the literature to determine the prevalence of CAFRs among dogs and cats with pruritus and skin diseases. We searched two databases for pertinent references on August 18, 2016. Among 490 and 220 articles respectively found in the Web of Science (Science Citation Index Expanded) and CAB Abstract databases, we selected 22 and nine articles that reported data usable for CAFR prevalence determination in dogs and cats, respectively. The prevalence of CAFR in dogs and cats was found to vary depending upon the type of diagnoses made. Among dogs presented to their veterinarian for any diagnosis, the prevalence was 1 to 2% and among those with skin diseases, it ranged between 0 and 24%. The range of CAFR prevalence was similar in dogs with pruritus (9 to 40%), those with any type of allergic skin disease (8 to 62%) and in dogs diagnosed with atopic dermatitis (9 to 50%). In cats presented to a university hospital, the prevalence of CAFR was less than 1% (0.2%), while it was fairly homogeneous in cats with skin diseases (range: 3 to 6%), but higher in cats with pruritus (12 to 21%) than in cats with allergic skin disease (5 to 13%). Among dogs and cats with pruritus and those suspected of allergic skin disease, the prevalence of CAFR is high enough to justify this syndrome to be ruled-out with a restriction (elimination)-provocation dietary trial. This must especially be considered in companion animals with nonseasonal pruritus or signs of allergic dermatitis.

  14. Continued Statin Prescriptions After Adverse Reactions and Patient Outcomes: A Cohort Study.

    Science.gov (United States)

    Zhang, Huabing; Plutzky, Jorge; Shubina, Maria; Turchin, Alexander

    2017-08-15

    Many patients discontinue statin treatment, often after having a possible adverse reaction. The risks and benefits of continued statin therapy after an adverse reaction are not known. To examine the relationship between continuation of statin therapy (any prescription within 12 months after an adverse reaction) and clinical outcomes. Retrospective cohort study. Primary care practices affiliated with 2 academic medical centers. Patients with a presumed adverse reaction to a statin between 2000 and 2011. Information on adverse reactions to statins was obtained from structured electronic medical record data or natural-language processing of narrative provider notes. The primary composite outcome was time to a cardiovascular event (myocardial infarction or stroke) or death. Most (81%) of the adverse reactions to statins were identified from the text of electronic provider notes. Among 28 266 study patients, 19 989 (70.7%) continued receiving statin prescriptions after the adverse reaction. Four years after the presumed adverse event, the cumulative incidence of the composite primary outcome was 12.2% for patients with continued statin prescriptions, compared with 13.9% for those without them (difference, 1.7% [95% CI, 0.8% to 2.7%]; P statin was prescribed after the adverse reaction, 2014 (26.5%) had a documented adverse reaction to the second statin, but 1696 (84.2%) of those patients continued receiving statin prescriptions. The risk for recurrent adverse reactions to statins could not be established for the entire sample. It was also not possible to determine whether patients actually took the statins. Continued statin prescriptions after an adverse reaction were associated with a lower incidence of death and cardiovascular events. Chinese National Key Program of Clinical Science, National Natural Science Foundation of China, and Young Scientific Research Fund of Peking Union Medical College Hospital.

  15. The importance of direct patient reporting of suspected adverse drug reactions: a patient perspective.

    Science.gov (United States)

    Anderson, Claire; Krska, Janet; Murphy, Elizabeth; Avery, Anthony

    2011-11-01

    To explore the opinions of patient reporters to the UK Yellow Card Scheme (YCS) on the importance of the scheme. Postal questionnaires were distributed on our behalf to all patient reporters submitting a Yellow Card to the Medicines and Healthcare Regulatory Agency (MHRA) between March and December 2008, with one follow-up reminder to non-responders. Qualitative analysis was undertaken of responses to an open question asking why respondents felt patient reporting was important. This was followed up by telephone interviews with a purposive sample of selected respondents. There were 1362 evaluable questionnaires returned from 2008 distributed (68%) and 1238 (91%) respondents provided a total of 1802 comments. Twenty-seven interviews were conducted, which supported and expanded the views expressed in the questionnaire. Four main themes emerged, indicating views that the YCS was of importance to pharmacovigilance in general, manufacturers and licensing authorities, patients and the public and health professionals. Reporters viewed the YCS as an important opportunity to describe their experiences for the benefit of others and to contribute to pharmacovigilance. The scheme's independence from health professionals was regarded as important, in part to provide the patient perspective to manufacturers and regulators, but also because of dismissive attitudes and under-reporting by health professionals. Direct patient reporting through the YCS is viewed as important by those who have used the scheme, in order to provide the patient experience for the benefit of pharmacovigilance, as an independent perspective from those of health professionals. © 2011 The Authors. British Journal of Clinical Pharmacology © 2011 The British Pharmacological Society.

  16. Incidence and cost estimate of treating pediatric adverse drug reactions in Lagos, Nigeria

    Directory of Open Access Journals (Sweden)

    Kazeem Adeola Oshikoya

    Full Text Available CONTEXT AND OBJECTIVES: Adverse drug reactions (ADRs may cause prolonged hospital admissions with high treatment costs. The burden of ADRs in children has never been evaluated in Nigeria. The incidence of pediatric ADRs and the estimated cost of treatment over an 18-month period were determined in this study. DESIGN AND SETTING: Prospective observational study on children admitted to the pediatric wards of the Lagos State University Teaching Hospital (LASUTH in Nigeria, between July 2006 and December 2007. METHODS: Each patient was assessed for ADRs throughout admission. Medical and non-medical costs to the hospital and patient were estimated for each ADR by reviewing the medical and pharmacy bills, medical charts and diagnostic request forms and by interviewing the parents. Cost estimates were performed in 2007 naira (Nigeria currency from the perspectives of the hospital (government, service users (patients and society (bearers of the total costs attributable to treating ADRs. The total estimated cost was expressed in 2007 United States dollars (USD. RESULTS: Two thousand and four children were admitted during the study; 12 (0.6% were admitted because of ADRs and 23 (1.2% developed ADR(s during admission. Forty ADRs were suspected in these 35 patients and involved 53 medicines. Antibiotics (50% were the most suspected medicines. Approximately 1.83 million naira (USD 15,466.60 was expended to manage all the patients admitted due to ADRs. CONCLUSIONS: Treating pediatric ADRs was very expensive. Pediatric drug use policies in Nigeria need to be reviewed so as to discourage self-medication, polypharmacy prescription and sales of prescription medicines without prescription.

  17. HLA-associated drug hypersensitivity and the prediction of adverse drug reactions.

    Science.gov (United States)

    Negrini, Simone; Becquemont, Laurent

    2017-10-01

    Adverse drug reactions are an important cause of morbidity and mortality and constitute the leading reason of drug withdrawal from the market. Besides classical reactions that are related to pharmacologic activity of the drug, some reactions are unpredictable, not dose dependent, and seem to occur in genetically predisposed individuals. The majority of this reaction is immunologically driven and they are referred to as hypersensitivity reactions. A growing number of studies provided evidences that specific HLA alleles increase the risk of developing hypersensitivity drug reactions. In this context, drug hypersensitivities that have more robust pharmacogenetic data include abacavir hypersensitivity syndrome and severe cutaneous adverse reactions induced by allopurinol and carbamazepine.

  18. Healthcare professionals and pharmacovigilance of pediatric adverse drug reactions: a 5-year analysis of Adverse Events Reporting System database of the Food and Drug Administration.

    Science.gov (United States)

    Bigi, Caterina; Tuccori, Marco; Bocci, Guido

    2017-02-17

    To analyze the Adverse Events Reporting System (AERS) database of the Food and Drug Administration (FDA), investigating the characteristics of pediatric adverse drug reactions (ADRs) and describing the effective participation of healthcare professionals in the reporting activity. Reports of ADRs were obtained from the FDA website. Only ADRs in pediatric subjects (divided by age, by country and by professional category) were included into the analysis. The drugs suspected as primary cause of the ADRs in pediatric subjects and their principal anatomic group according to the Anatomical Therapeutic Chemical classification system were considered. To classify the ADRs, the Medical Dictionary for Regularity Activities terminology was adopted. Between 2008 and 2012, FDA collected 113,077 ADRs in pediatric patients. Of the total pediatric ADR reports, those performed by medical doctors were 32%, followed by consumers (26%) and healthcare professionals (25%). Most of the ADR reports were related to the adolescent group (39%). Healthcare professionals resulted the category with the highest rate of ADR reports in neonates and infants. Drugs acting on nervous system and antineoplastic/immunomodulating agents were the most involved the pediatric ADR reports. Pyrexia, convulsion, vomiting and accidental overdose were the reactions more reported both from healthcare professionals and medical doctors. The present study describes the pediatric ADR reports of the FDA database through healthcare professional's perspective, describing the various aspects of pediatric pharmacovigilance.

  19. A study on adverse drug reactions in a tertiary care hospital of ...

    African Journals Online (AJOL)

    Ratan J. Lihite

    2016-06-27

    Jun 27, 2016 ... Abstract Objective: Purpose of this study was to monitor adverse drug reactions reported from various departments of a tertiary care hospital in Northeast India. Reported adverse drug reactions were analysed for causality and severity assessment. Methods: This cross sectional study was conducted in a ...

  20. Analysis on 113 cases of adverse reactions caused by β-lactam ...

    African Journals Online (AJOL)

    Analysis on 113 cases of adverse reactions caused by β-lactam antibiotics. ... African Journal of Traditional, Complementary and Alternative Medicines ... The objectives of this study were to learn about the characteristics and rules of the occurrence of adverse reactions caused by lactam antibiotics and provide a reference ...

  1. ADVERSE REACTIONS ATTRIBUTED TO SUMATRIPTAN - A POSTMARKETING STUDY IN GENERAL-PRACTICE

    NARCIS (Netherlands)

    OTTERVANGER, JP; VANWITSEN, TB; VALKENBURG, HA; GROBBEE, DE; STRICKER, BHC

    1994-01-01

    There are several reports on cardiac adverse reactions attributed to the antimigraine drug sumatriptan in the recent literature. In order to assess the frequency and the character of adverse reactions to sumatriptan, a postmarketing cohort study was performed one year after registration of the drug

  2. A study on adverse drug reactions in a tertiary care hospital of ...

    African Journals Online (AJOL)

    Objective: Purpose of this study was to monitor adverse drug reactions reported from various departments of a tertiary care hospital in Northeast India. Reported adverse drug reactions were analysed for causality and severity assessment. Methods: This cross sectional study was conducted in a tertiary care hospital at ...

  3. [Hospital haemovigilance and adverse events or reactions: who notifies and what?].

    Science.gov (United States)

    Gouëzec, H; Bazin, A; Lassale, B; Huchet, C; Artéro, N

    2012-11-01

    The French haemovigilance system designates a physician in charge of haemovigilance in each hospital. She/he collects the adverse reactions and events reported by medical staff or nurses. In 2010, 7360 (2.42/1000 units) adverse reactions and 518 adverse events (excepted donors) were reported. These results mean that the system is particularly effective in hospitals. This study collected the opinion of physicians in charge of haemovigilance about this organization. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

  4. The knowledge, attitude and behaviours of nurses about pharmacovigilance, adverse drug reaction and adverse event reporting in a state hospital.

    Science.gov (United States)

    Vural, Fisun; Ciftci, Seval; Vural, Birol

    2014-01-01

    With the use of any drug comes the possibility of unintended consequences which when harmful are referred to as adverse drug reactions (ADRs). The development of national pharmacovigilance systems is the responsibility of all health workers. The aim of this study was to investigate the knowledge of nurses about pharmacovigilance and attitudes about ADR and adverse event reporting. This descriptive-cross sectional study was performed in 112 nurses working in a public hospital. The questionnaire was applied about pharmacovigilance and adverse drug reactions. The knowledge, attitudes and practices about adverse drug reactions were asked. The 74.1% of the nurses definition of "severe adverse effect" of drug therapy. The ratio of participants who knew that ADRs are reported to contact person responsible from pharmacovigilance was 34.9%. Although 70.5% of nurses knew the necessity of ADR reporting, the 8% of the nurses knew Turkish Pharmacovigilance Center (TÜFAM). Only 8% of nurses reported ADRs in their professionality. Although most of the participants knew the importance of ADR event reporting, event reporting was low. Thiese results showed that there is a lack of knowledge about pharmacovigilance. Futher studies with different settings and healthcare staff are needed to improve awareness about pharmacovigilance.

  5. Adverse reactions to dietary supplements containing red yeast rice: assessment of cases from the Italian surveillance system.

    Science.gov (United States)

    Mazzanti, Gabriela; Moro, Paola Angela; Raschi, Emanuel; Da Cas, Roberto; Menniti-Ippolito, Francesca

    2017-04-01

    Red yeast rice (RYR) is contained in dietary supplements for patients with dyslipidemia. RYR supplements contain monacolin K, which is chemically identical to lovastatin, a licensed drug with a well-known risk profile. We aim to describe the safety profile of RYR by analysing spontaneous reports of suspected adverse reactions (ARs). Within the Italian Surveillance System of Natural Health Products, suspected ARs were collected and evaluated by a multidisciplinary group of experts to assess causality using the WHO-UMC system or the CIOMS/RUCAM score, for hepatic reactions. The public version of the WHO-Vigibase was also queried. From April 2002 to September 2015, out of 1261 total reports, 52 reports concerning 55 ARs to RYR dietary supplements were collected. ARs consisted in myalgia and/or increase in creatine phosphokinase (19), rhabdomyolysis (1), liver injury (10), gastrointestinal reactions (12), cutaneous reactions (9) and other reactions (4). Women were involved in 70% of cases. In 13 cases, the reaction required hospitalization, and 28 patients were taking other medications. Dechallenge was positive in 40 reactions (73%), rechallenge was positive in 7. Causality resulted as certain (1), probable (31, 56%), possible (18, 34%), unlikely (3) or unassessable (2). Similar distribution emerged from the WHO-Vigibase. The potential safety signals of myopathies and liver injury raise the hypothesis that the safety profile of RYR is similar to that of statins. Continuous monitoring of dietary supplements should be promoted to finally characterize their risk profile, thus supporting regulatory bodies for appropriate actions. © 2017 The British Pharmacological Society.

  6. Adverse reactions to antituberculosis drugs in Manguinhos, Rio de Janeiro, Brazil

    Directory of Open Access Journals (Sweden)

    Glauciene Santana Damasceno

    2013-01-01

    Full Text Available OBJECTIVES: This study aimed to characterize and estimate the frequency of adverse reactions to antituberculosis drugs in the population treated at the Centro de Saúde Escola Germano Sinval Faria, a primary health care clinic in Manguinhos, Rio de Janeiro City, and to explore the relationship between adverse drug reactions and some of the patients' demographic and health characteristics. METHODS: This descriptive study was conducted via patient record review of incident cases between 2004 and 2008. RESULTS: Of the 176 patients studied, 41.5% developed one or more adverse reactions to antituberculosis drugs, totaling 126 occurrences. The rate of adverse reactions to antituberculosis drugs was higher among women, patients aged 50 years or older, those with four or more comorbidities, and those who used five or more drugs. Of the total reactions, 71.4% were mild. The organ systems most affected were as follows: the gastrointestinal tract (29.4%, the skin and appendages (21.4%, and the central and peripheral nervous systems (14.3%. Of the patients who experienced adverse reactions to antituberculosis drugs, 65.8% received no drug treatment for their adverse reactions, and 4.1% had one of the antituberculosis drugs suspended because of adverse reactions. "Probable reactions" (75% predominated over "possible reactions" (24%. In the study sample, 64.3% of the reactions occurred during the first two months of treatment, and most (92.6% of the reactions were ascribed to the combination of rifampicin + isoniazid + pyrazinamide (Regimen I. A high dropout rate from tuberculosis treatment (24.4% was also observed. CONCLUSION: This study suggests a high rate of adverse reactions to antituberculosis drugs.

  7. Campania Preventability Assessment Committee (Italy): A Focus on the Preventability of Non-steroidal Anti-inflammatory Drugs' Adverse Drug Reactions

    OpenAIRE

    Maurizio Sessa; Liberata Sportiello; Annamaria Mascolo; Cristina Scavone; Silvia Gallipoli; Gabriella di Mauro; Daniela Cimmaruta; Concetta Rafaniello; Annalisa Capuano

    2017-01-01

    Purpose: This study aims to investigate preventability criteria of adverse drug reactions (ADRs) involving non-steroidal anti-inflammatory drugs (NSAIDs) by analyzing individual case safety reports (ICSRs) sent through Campania region (Italy) spontaneous reporting system from July 2012 to October 2016. Methods: For all the ICSRs that reported NSAIDs as suspected drug, a trained multidisciplinary team of Campania Pharmacovigilance Regional Centre composed of clinical pharmacologists and pha...

  8. Use of a trigger tool to detect adverse drug reactions in an emergency department.

    Science.gov (United States)

    de Almeida, Silvana Maria; Romualdo, Aruana; de Abreu Ferraresi, Andressa; Zelezoglo, Giovana Roberta; Marra, Alexandre R; Edmond, Michael B

    2017-11-15

    Although there are systems for reporting adverse drug reactions (ADR), these safety events remain under reported. The low-cost, low-tech trigger tool method is based on the detection of events through clues, and it seems to increase the detection of adverse events compared to traditional methodologies. This study seeks to estimate the prevalence of adverse reactions to drugs in patients seeking care in the emergency department. Retrospective study from January to December, 2014, applying the Institute for Healthcare Improvement (IHI) trigger tool methodology for patients treated at the emergency room of a tertiary care hospital. The estimated prevalence of adverse reactions in patients presenting to the emergency department was 2.3% [CI95 1.3% to 3.3%]; 28.6% of cases required hospitalization at an average cost of US$ 5698.44. The most common triggers were hydrocortisone (57% of the cases), diphenhydramine (14%) and fexofenadine (14%). Anti-infectives (19%), cardiovascular agents (14%), and musculoskeletal drugs (14%) were the most common causes of adverse reactions. According to the Naranjo Scale, 71% were classified as possible and 29% as probable. There was no association between adverse reactions and age and sex in the present study. The use of the trigger tool to identify adverse reactions in the emergency department was possible to identify a prevalence of 2.3%. It showed to be a viable method that can provide a better understanding of adverse drug reactions in this patient population.

  9. Adverse reactions and other factors that impact subsequent blood donation visits.

    Science.gov (United States)

    Custer, Brian; Rios, Jorge A; Schlumpf, Karen; Kakaiya, Ram M; Gottschall, Jerome L; Wright, David J

    2012-01-01

    The importance of adverse reactions in terms of donor safety recently has received significant attention, but their role in subsequent donation behavior has not been thoroughly investigated. Six REDS-II blood centers provided data for this analysis. Summary minor and major adverse reaction categories were created. The influence of adverse reactions on donation was examined in two ways: Kaplan-Meier curves were generated to determine the cumulative pattern of first return, and adjusted odds ratios (AORs) for demographic and other factors positively and negatively associated with return were estimated using multivariable logistic regression. Donors who had major reactions had longer times to return than donors with minor or no reactions. The AOR of returning for donors with major reactions was 0.32 (95% confidence interval [CI], 0.28-0.37) and with minor reactions 0.59 (95% CI, 0.56-0.62) when compared to donors who did not have reactions. Conversely, the most important factors positively associated with return were the number of donations in the previous year and increasing age. Subsequent return, whether a major, minor, or no reaction occurred, varied by blood center. Factors that are associated with the risk of having adverse reactions were not substantial influences on the return after adverse reactions. Having an adverse reaction leads to significantly lower odds of subsequent donation irrespective of previous donation history. Factors that have been associated with a greater risk of adverse reactions were not important positive or negative predictors of return after a reaction. © 2011 American Association of Blood Banks.

  10. Adverse Reactions to Zolpidem: Case Reports and a Review of the Literature

    Science.gov (United States)

    Miyaoka, Tsuyoshi; Tsuji, Seiichi; Inami, Yasushi; Nishida, Akira; Horiguchi, Jun

    2010-01-01

    Objective: Zolpidem, a nonbenzodiazepine hypnotic, is very effective and widely prescribed in clinical practice for the treatment of insomnia and is thought to have few adverse effects. However, zolpidem-induced adverse effects have begun to be reported in the literature, but few systemic descriptions of the adverse effects (especially for psychotic reactions) of zolpidem have been undertaken. In light of the accumulating reports of adverse reactions to zolpidem, we present 2 case reports of zolpidem-induced adverse effects and review the literature on this subject. Data Sources: Articles were selected by the authors on the basis of our experience and by a PubMed search using the terms zolpidem or side effects or adverse effects or adverse reactions. Study Selection and Data Extraction: Publications relevant to the objective of this article were obtained (1992–2010), and some adverse neuropsychiatric reactions were summarized. Data Synthesis: Zolpidem has been associated with the development of adverse neuropsychiatric reactions, such as hallucinations/sensory distortion, amnesia, sleepwalking/somnambulism, and nocturnal eating. The following 4 variables should be considered when prescribing zolpidem: (1) gender: women have been found to have a significantly higher serum zolpidem concentration than men; (2) zolpidem dose: the adverse reactions that develop are dose dependent; (3) protein binding affinity: a high proportion of zolpidem is protein bound; therefore, low serum albumin results in a higher level of free zolpidem leading to adverse psychiatric reactions; and (4) cytochrome P450 (CYP) isoenzyme inhibition: concomitant administration of zolpidem and other drugs may cause interactions that lead to increased concentrations of zolpidem. Conclusions: Zolpidem is clinically very effective in treating insomnia. However, while rare, zolpidem-induced unusual complex behavior may develop. Primary care physicians should be alert to the possible unusual complex

  11. Identifying adverse drug reactions associated with drug-drug interactions: data mining of a spontaneous reporting database in Italy.

    Science.gov (United States)

    Leone, Roberto; Magro, Lara; Moretti, Ugo; Cutroneo, Paola; Moschini, Martina; Motola, Domenico; Tuccori, Marco; Conforti, Anita

    2010-08-01

    Drug-drug interactions (DDIs) are an important cause of adverse drug reactions (ADRs). Many studies have recently considered this issue, but most of them focus only on potential interactions and are often related to the hospital setting. A spontaneous reporting database could be a valuable resource for detection of ADRs associated with DDIs; however, data in the literature are limited. To detect those patients treated with potentially interacting drugs and the cases where reported adverse reactions are a possible consequence of DDIs, using an Italian spontaneous reporting database. The data were obtained from a database containing all reports of suspected ADRs from five Italian regions (January 1990 to December 2007) that are the main contributors to the Italian spontaneous reporting system. All reports containing at least two drugs, reported as being suspected of causing the ADR or as concomitant medication, were selected and a list of drug pairs was drawn up. We performed a search to verify which drug pairs are considered a potential DDI, using the Internet version of the DRUGDEX(R) system. For each report containing a potential DDI, we verified whether the description of the adverse reaction corresponded to the interaction effect. The database contained 45 315 reports, of which 17 700 (39.1%) had at least two reported drugs. We identified 5345 (30.2%) reports with potential DDIs, and in 1159 (21.7%) of these reports a related ADR was reported. The percentage of reports with potential DDIs increased in relation to the number of concomitantly administered drugs, ranging from 9.8% for two drugs to 88.3% for eight or more drugs. The percentages of serious or fatal reports of ADRs associated with a DDI were significantly higher than other reports analysed. The mean age, percentage of male patients and the mean number of drugs were also significantly higher in reports with DDIs than in other reports. In 235 of 1159 reports (20.3%), both interacting drugs were

  12. Mechanisms in adverse reactions to food. The sinuses

    DEFF Research Database (Denmark)

    Høst, A

    1995-01-01

    Food allergy is an extremely rare cause of chronic sinusitis. Mucosal inflammation in chronic sinusitis is rarely caused by allergic reactions to foods but rather viral infections in the upper respiratory tract.......Food allergy is an extremely rare cause of chronic sinusitis. Mucosal inflammation in chronic sinusitis is rarely caused by allergic reactions to foods but rather viral infections in the upper respiratory tract....

  13. Potential Mechanisms of Hematological Adverse Drug Reactions in Patients Receiving Clozapine in Combination With Proton Pump Inhibitors.

    Science.gov (United States)

    Wiciński, Michał; Węclewicz, Mateusz M; Miętkiewicz, Mateusz; Malinowski, Bartosz; Grześk, Elżbieta; Klonowska, Joanna

    2017-03-01

    Clozapine is a second-generation antipsychotic which has proven efficacy in treating the symptoms of schizophrenia. Although clozapine therapy is associated with a number of adverse drug reactions, it is frequently used. One of the most common adverse drug reactions is gastroesophageal reflux disease which is an indication for treatment with proton pump inhibitors (PPIs). Coadministration of clozapine and PPIs increases the risk of hematological adverse drug reactions, including neutropenia and agranulocytosis. The mechanism in idiosyncratic agranulocytosis is not dose related and involves either a direct toxic or an immune-allergic effect. It is suspected that the clozapine metabolites nitrenium ion and N-desmethylclozapine may cause apoptosis or impair growth of granulocytes. Formation of N-desmethylclozapine is correlated with activity of the cytochrome P450 enzymes 1A2 and 3A4 (CYP1A2 and CYP3A4). Nitrenium ion is produced by the flavin-containing monooxygenase system of leukocytes. A drug interaction between clozapine and a PPI is a consequence of the induction of common metabolic pathways either by the PPI or clozapine. Findings to date suggest that indirect induction of flavin-containing monooxygenase by omeprazole through the aryl hydrocarbon receptor increases the expression of the enzyme mRNA and in the long term may cause the increase in activity. Moreover, induction of CYP1A2, especially by omeprazole and lansoprazole, may increase the serum concentration of N-desmethylclozapine, which can accumulate in lymphocytes and may achieve toxic levels. Another hypothesis that may explain hematological adverse drug reactions is competitive inhibition of CYP2C19, which may contribute to increased serum concentrations of toxic metabolites.

  14. Signal Detection of Adverse Drug Reaction of Amoxicillin Using the Korea Adverse Event Reporting System Database.

    Science.gov (United States)

    Soukavong, Mick; Kim, Jungmee; Park, Kyounghoon; Yang, Bo Ram; Lee, Joongyub; Jin, Xue Mei; Park, Byung Joo

    2016-09-01

    We conducted pharmacovigilance data mining for a β-lactam antibiotics, amoxicillin, and compare the adverse events (AEs) with the drug labels of 9 countries including Korea, USA, UK, Japan, Germany, Swiss, Italy, France, and Laos. We used the Korea Adverse Event Reporting System (KAERS) database, a nationwide database of AE reports, between December 1988 and June 2014. Frequentist and Bayesian methods were used to calculate disproportionality distribution of drug-AE pairs. The AE which was detected by all the three indices of proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC) was defined as a signal. The KAERS database contained a total of 807,582 AE reports, among which 1,722 reports were attributed to amoxicillin. Among the 192,510 antibiotics-AE pairs, the number of amoxicillin-AE pairs was 2,913. Among 241 AEs, 52 adverse events were detected as amoxicillin signals. Comparing the drug labels of 9 countries, 12 adverse events including ineffective medicine, bronchitis, rhinitis, sinusitis, dry mouth, gastroesophageal reflux, hypercholesterolemia, gastric carcinoma, abnormal crying, induration, pulmonary carcinoma, and influenza-like symptoms were not listed on any of the labels of nine countries. In conclusion, we detected 12 new signals of amoxicillin which were not listed on the labels of 9 countries. Therefore, it should be followed by signal evaluation including causal association, clinical significance, and preventability.

  15. Are excipients really inert ingredients? A review of adverse reactions to excipients in oral dermatologic medications in Canada.

    Science.gov (United States)

    Noiles, Kristin; Vender, Ronald

    2010-01-01

    Whereas several literature reviews have discussed the role of excipients in drug-related reactions, no article has focused specifically on those found in oral dermatologic medications. The Compendium of Pharmaceuticals and Specialties (CPS) was used to reference the inert ingredients found in oral dermatologic medications. An extensive literature review was subsequently conducted using PubMed and MEDLINE to document adverse reactions to these excipients. Sixty-three oral dermatologic medications were reviewed. Lactose was commonly used as a filler. Several medications indicated that they were dye, tartrazine, or gluten free. Three medications were found to contain soybean oil and one was found to contain peanut oil. Although there are documented reactions to excipients in other products in the literature, few reports outline reactions to excipients in oral dermatologic medications. Whether this low frequency is accurate or whether it is due to a lack of reporting remains unknown. If the latter reasoning is correct, dermatologists must be more aware of these possible reactions. This article serves as a reference guide for dermatologists to aid in prescribing medications to individuals with known sensitivities and to assist in working up patients with suspected reactions to inert ingredients.

  16. Adverse drug reactions and safety considerations of NSAIDs: clinical analysis.

    Science.gov (United States)

    Bahadur, Shiv; Keshri, Lav; Pathak, Kamla

    2011-11-01

    NSAIDs are the most frequently used drugs for treatment, in Europe and the United States, accounting for approximately 5% of all prescriptions. Moreover, the use of NSAIDs is increasing because these constitute the first-line drug therapy for a wide range of rheumatic conditions. This increase is in part the result of the increasing population of elderly patients, who constitute the group of patients with greatest demand for these agents. There are many types of NSAIDs that vary in potency, action and potential side effects. Thus various efforts have been made to determine the safety considerations including adverse drug effects, duration of drug therapy, drug interactions, precautions and other drugs applied to reduce side effects. Researchers have introduced some novel techniques to diagnose NSAIDs related adverse effects on the gastrointestinal mucosa. The researchers dealing with the development of drug delivery system for these drugs should aim at designing a therapeutically efficacious dosage form with reduced side/adverse effects. Thus an effort has been made in this review to deal with the safety parameters of various NSAIDs with a special emphasis on preclinical and clinical safety analysis and various attempts to minimize the side effects by structural modification or by drug delivery system.

  17. Self-reported adverse tattoo reactions: a New York City Central Park study.

    Science.gov (United States)

    Brady, Bobbi G; Gold, Heidi; Leger, Elizabeth A; Leger, Marie C

    2015-08-01

    Although permanent tattoos are becoming increasingly commonplace, there is a paucity of epidemiological data on adverse tattoo reactions. Several European studies have indicated that tattoo reactions may be relatively common, although the extent of this phenomenon in the United States is largely unknown. To provide insights into the prevalence and nature of adverse tattoo reactions. We administered a survey about adverse tattoo reactions to 300 randomly selected tattooed people in Central Park, New York City. Of 300 participants, 31 (10.3%) reported experiencing an adverse tattoo reaction, 13 (4.3%) reported acute reactions, and 18 (6.0%) suffered from a chronic reaction involving a specific colour lasting for >4 months. Forty-four per cent of colour-specific reactions were to red ink, which was only slightly higher than the frequency of red ink in the sampled population (36%). Twenty-five per cent of chronic reactions were to black ink, which was less than expected based on the number of respondents with black tattoos (90.3%). Study participants with chronic, colour-specific reactions had more tattoo colours than those without reactions. This study shows that tattoo reactions are relatively common, and that further investigation into the underlying causes is merited. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  18. Adverse reactions, psychological factors, and their effect on donor retention in men and women

    NARCIS (Netherlands)

    Veldhuizen, I.; Atsma, F.; Dongen, A. van; Kort, W. de

    2012-01-01

    BACKGROUND: This study investigates the effect of a vasovagal reaction (VVR) or needle reaction (NR) on the risk of stopping as a blood donor, taking into account variables from the Theory of Planned Behavior (TPB). Is stopping risk solely related to the adverse reaction itself, or do the TPB

  19. Analysis of a questionnaire on adverse reactions to blood donation in Japan.

    Science.gov (United States)

    Inaba, S; Takanashi, M; Matsuzaki, K; Ono, Y; Nakajima, K; Shibata, R; Tadokoro, K; Ishikawa, Y; Kinukawa, N

    2013-02-01

    In 2007, the Japanese Red Cross Blood Center performed a large-scale questionnaire study of post-donation adverse reactions. The questionnaire was distributed to 98,389 donors, and the answers were returned by 55,231 (56.1%). In total, 2,877 (5.2%) complained of an adverse reaction. Assuming that there were no adverse reactions for the 46,150 donors who did not reply, the rate of adverse reaction can be speculated to be 2.8%. Our study strongly suggests that blood centers have long underestimated the risks of vaso-vagal reactions. Taking at least 6h of careful rest after donation would be a helpful counter measure. Copyright © 2012 Elsevier Ltd. All rights reserved.

  20. Quality of life in children with adverse drug reactions: a narrative and systematic review.

    Science.gov (United States)

    Del Pozzo-Magaña, Blanca R; Rieder, Michael J; Lazo-Langner, Alejandro

    2015-10-01

    Adverse drug reactions are a common problem affecting adults and children. The economic impact of the adverse drug reactions has been widely evaluated; however, studies of the impact on the quality of life of children with adverse drug reactions are scarce. The aim was to evaluate studies assessing the health-related quality of life of children with adverse drug reactions. We conducted a systematic review that included the following electronic databases: MEDLINE, EMBASE and the Cochrane Library (including the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, the Cochrane Controlled Trials Register and the Health Technology Assessment Databases). Nine studies were included. Four of the studies were conducted in children with epilepsy; the rest of them involved children with chronic viral hepatitis, Crohn's disease, paediatric cancer and multiple adverse drug reactions compared with healthy children. Based on their findings, authors of all studies concluded that adverse drug reactions had a negative impact on the quality of life of children. No meta-analysis was conducted given the heterogeneous nature of the studies. To date, there is no specific instrument that measures quality of life of children with adverse drug reactions, and the information available is poor and variable. In general, adverse drug reactions have a negative impact on the quality of life of affected children. For those interested in this area, more work needs to be done to improve tools that help to evaluate efficiently the health-related quality of life of children with adverse drug reactions and chronic diseases. © 2014 The British Pharmacological Society.

  1. Adverse reactions in blood and apheresis donors: experience from two Italian transfusion centres.

    Science.gov (United States)

    Crocco, Isabella; Franchini, Massimo; Garozzo, Giovanni; Gandini, Anna Rosa; Gandini, Giorgio; Bonomo, Pietro; Aprili, Giuseppe

    2009-01-01

    Blood and apheresis donations are widely considered to be safe with a low incidence of adverse reactions and injuries; however, data reported in the medical literature on the prevalence of adverse events in donors and studies on the predictive risk factors for donor reactions are limited and contradictory. From January 2002 to December 2006 we recorded every adverse reaction verified during 240,596 consecutive blood and apheresis donations (183,855 homologous whole blood donations, 6,669 autologous whole blood donations, 38,647 plasmapheresis, 2,641 plateletpheresis and 8,784 multicomponent donations) at the Italian Transfusion Centres of Verona and Ragusa,. Using a special, pre-arranged form within the quality system, a total of 686 adverse reactions (related to 0.28% of all donations) were recorded. Vasovagal reactions, mostly of mild intensity, were the most commonly observed adverse reactions, with a frequency of 0.20% (487/ 240,596). The frequency of the vasovagal reactions varied according to the different types of donation, being 0.19% (346/183,855) for homologous whole blood donations, 0.24% (16/6,669) for autologous whole blood donations, 0.16% (63/38,647) for plasmapheresis, 0.68% (18/2,641) for plateletpheresis and 0.49 (43/8,784) for multicomponent donations. Citrate toxicity was reported in 0.38% (189/50,072) of apheresis donations. Severe adverse reactions were very rare, as they occurred in 0.004% of the donations (10/240,596). In conclusion, the results of our 5-year survey document that apheresis and blood donation are safe procedures for the donor with a low incidence of adverse reactions; the adverse reactions that did occur were mostly mild and resolved rapidly.

  2. Metal-on-Metal Hip Arthroplasty: A Review of Adverse Reactions and Patient Management

    Directory of Open Access Journals (Sweden)

    James Drummond

    2015-06-01

    Full Text Available Recent alarming joint registry data highlighting increased revision rates has prompted further research into the area of metal-on-metal hip replacements and resurfacings. This review article examines the latest literature on the topic of adverse reactions to metal debris and summarises the most up-to-date guidelines on patient management. Adverse reactions to metal debris can cause significant damage to soft tissue and bone if not diagnosed early. Furthermore, not every patient with an adverse reaction to metal debris will be symptomatic. As such, clinicians must remain vigilant when assessing and investigating these patients in order to detect failing implants and initiate appropriate management.

  3. Retributive reactions to suspected offenders: The importance of social categorizations and guilt probability

    NARCIS (Netherlands)

    van Prooijen, J.W.

    2006-01-01

    In the current research, the author investigates the influence of social categorizations on retributive emotions (e.g., anger) and punishment intentions when people evaluate suspected offenders as independent observers. It is argued that information that guilt is certain or uncertain (i.e., guilt

  4. Adverse drug reactions associated with antiretroviral therapy in ...

    African Journals Online (AJOL)

    ... prone to experience gynaecomastia and peripheral neuropathy. In addition, patients aged 30–44 years reported the most ADRs. Most reactions resulted from the use of stavudine, efavirenz, zidovudine, nevirapine and tenofovir in the population groups identified in this study. Keywords: pharmacovigilance, drug safety, ...

  5. Anacin induced adverse drug reaction: A case report | Momoh ...

    African Journals Online (AJOL)

    Anacin; a brand of aspirin tablets (containing 300mg acetylsalicylic acid), is a widely used analgesics. It is recognized as ... Additionally, a detailed history should be taken prior to prescribing and appropriate reporting should be made to relevant health authorities when such severe reactions are observed. Keyword: Anacin ...

  6. Evaluation of canine adverse food reactions by patch testing with single proteins, single carbohydrates and commercial foods.

    Science.gov (United States)

    Johansen, Cornelia; Mariani, Claire; Mueller, Ralf S

    2017-10-01

    Adverse food reaction (AFR) is an important differential diagnosis for the pruritic dog. It is usually diagnosed by feeding an elimination diet with a novel protein and carbohydrate source for eight weeks followed by subsequent food provocation. A previous study demonstrated that patch testing dogs with foods had a high sensitivity and negative predictability for selection of elimination diet ingredients. The aim of this study was to investigate patch testing with proteins, carbohydrates and dry commercial dog food in dogs to determine whether there was value in patch testing to aid the diagnosis of canine adverse food reaction. Twenty five privately owned dogs, with confirmed AFR, underwent provocation trials with selected food antigens and patch testing. For proteins, carbohydrates and dry dog food the sensitivity of patch testing was 100%, 70% and 22.2%, respectively; the negative predictive values of patch testing were 100%, 79% and 72%. The positive predictive values of patch testing for proteins and carbohydrates were 75% and 74%, respectively. This study confirmed that patch testing may be useful for the selection of a suitable protein source for an elimination diet in dogs with suspected AFR, but not as a diagnostic tool for canine AFR. Results for proteins are more reliable than for carbohydrates and the majority of positive patch test reactions were observed with raw protein. Patch testing with commercial dog food does not seem to be useful. © 2017 ESVD and ACVD.

  7. Adverse reactions to food additives in children with atopic symptoms

    DEFF Research Database (Denmark)

    Fuglsang, G.; Madsen, Charlotte Bernhard; Halken, S.

    1994-01-01

    dermatitis, asthma, urticaria, gastrointestinal symptoms), and citric acid (atopic dermatitis, gastrointestinal symptoms). The incidence of intolerance of food additives was 2% (6/335), as based on the double-blind challenge, and 7% (23/335), as based on the open challenge with lemonade. Children with atopic......, rhinitis, or urticaria. After a 2-week period on an additive-free diet, the children were challenged with the eliminated additives. The food additives investigated were coloring agents, preservatives, citric acid, and flavoring agents. Carbonated ''lemonade'' containing the dissolved additives was used...... and 335 were subjected to open challenge. A total of 23 children developed positive reactions after the open challenge. Sixteen of these patients accepted the double-blind challenge, and six showed a positive reaction to preservatives (atopic dermatitis, asthma, rhinitis), coloring agents (atopic...

  8. Adverse reactions to food additives in children with atopic symptoms

    DEFF Research Database (Denmark)

    Fuglsang, G; Madsen, G; Halken, S

    1994-01-01

    dermatitis, asthma, urticaria, gastrointestinal symptoms), and citric acid (atopic dermatitis, gastrointestinal symptoms). The incidence of intolerance of food additives was 2% (6/335), as based on the double-blind challenge, and 7% (23/335), as based on the open challenge with lemonade. Children with atopic......, rhinitis, or urticaria. After a 2-week period on an additive-free diet, the children were challenged with the eliminated additives. The food additives investigated were coloring agents, preservatives, citric acid, and flavoring agents. Carbonated "lemonade" containing the dissolved additives was used...... and 335 were subjected to open challenge. A total of 23 children developed positive reactions after the open challenge. Sixteen of these patients accepted the double-blind challenge, and six showed a positive reaction to preservatives (atopic dermatitis, asthma, rhinitis), coloring agents (atopic...

  9. Severe cutaneous adverse drug reactions of Chinese inpatients: a meta-analysis.

    Science.gov (United States)

    Deng, Qiancheng; Fang, Xia; Zeng, Qinghai; Lu, Jianyun; Jing, Chen; Huang, Jinhua

    2017-01-01

    The rate of severe cutaneous adverse drug reactions is low, and these reactions can result in death or disability. An evidence-based epidemiological study of severe cutaneous adverse drug reactions in China has not been reported. The aim of this study was to analyze epidemiology and characteristics of severe cutaneous adverse drug reactions of Chinese inpatients during the recent 15 years with meta-analysis. We retrospectively reviewed Chinese literature reporting severe cutaneous adverse drug reactions and collecting data from 2000 to 2015, which were in accordance with our inclusion criteria. All included data were analyzed with the Launch Open Meta-Analyst software. Twenty-five articles involving 928 cases with severe cutaneous adverse drug reactions were included. Men to women ratio was 1.14:1. Twenty-one per cent of the patients had drug allergy history. Antibiotics (26.0%), sedative hypnotics and anticonvulsants (21.6%), and antipyretic analgesics (17.1%) were the most common causative drugs. The most frequent clinical subtype was Stevens-Johnson syndrome (50.1%), followed by toxic epidermal necrolysis (25.4%), exfoliative dermatitis (21.0%) and drug-induced hypersensitivity syndrome (1.6%). In addition to skin rashes, patients with severe cutaneous adverse drug reactions suffered mostly from fever (73%), and blood routine abnormality (66.7%). This meta-analysis is limited by its retrospective design and by its methodological variation. The most common causative drugs were antibiotics and sedative hypnotics and anticonvulsants. Stevens-Johnson syndrome was the most frequent clinical subtype of severe cutaneous adverse drug reactions. In addition to skin rashes, patients with severe cutaneous adverse drug reactions suffered mostly from fever, mucosal lesion, and hematologic abnormalities.

  10. N-acetylcysteine in handgrip exercise: plasma thiols and adverse reactions.

    Science.gov (United States)

    Ferreira, Leonardo F; Campbell, Kenneth S; Reid, Michael B

    2011-04-01

    N-acetylcysteine (NAC) is a thiol donor with antioxidant properties that has potential use as an ergogenic aid. However, NAC is associated with adverse reactions that limit its use in humans. The authors evaluated NAC efficacy as a thiol donor before handgrip exercise, measuring changes in serum cysteine and glutathione status and recording adverse reactions in adult subjects across a range of doses. Healthy individuals ingested NAC capsules (9 ± 2 or 18 ± 4 mg/kg) or solution (0, 35, 70, or 140 mg/kg). Venous blood samples were collected and subjects answered a questionnaire about adverse reactions. Low doses of NAC (capsules) did not affect plasma cysteine or glutathione or cause adverse reactions. Adverse reactions to NAC solution were predominantly mild and gastrointestinal (GI). Intensity of GI reactions to 140 mg/kg NAC was significantly higher than placebo (in a.u., 0.67 ± 0.16 vs. 0.07 ± 0.04; p .05) in plasma cysteine for 70 mg/kg vs. 140 mg/kg. Similar increases were observed for the ratio of cysteine to total cysteine, which was directly related to handgrip exercise performance. Plasma glutathione was elevated and oxidized glutathione diminished (p adverse reactions.

  11. Cutaneous adverse drug reactions in a tertiary care teaching hospital in India: An intensive monitoring study

    Directory of Open Access Journals (Sweden)

    Sejal Thakkar

    2017-01-01

    Full Text Available Background: The epidemiological data based on intensive monitoring studies are limited for the cutaneous adverse drug reactions (CADRs in terms of incidence. Most of earlier Indian studies focused only on types and causative drugs of CADRs. Aim: The aim of this study is to analyze the CADRs with reference to the incidence, its subgroup analysis, causative drugs, and other clinical characteristics in Indian population. Methodology: Intensive monitoring study was carried out over a period of 3 years in the dermatology outpatient and inpatient department. CADRs due to only systematically administered drugs were considered. The WHO definition for CADR, the WHO causality definitions, modified Schumock and Thornton's criteria for preventability, and International Conference on Harmonisation E2A guidelines for seriousness were considered. Incidence was expressed in percentage and its 95% confidence interval. The incidence was analyzed on basis of characteristics of study population and CADRs. Results: A total of 171 CADRs were observed from 37,623 patients. The CADR incidence was 0.45% (95% CI: 0.39–0.53. The incidence did not significantly differ in different age groups and gender. Commonly observed CADRs were maculopapular rash (23.98%, urticaria (21.64%, and fixed drug eruptions (FDEs (18.13%. Antimicrobials (35.18% and nonsteroidal anti-inflammatory drugs (NSAIDs were suspected in all common CADRs. Anti-infective and NSAIDs were most commonly suspected drugs in overall CADRs, maculopapular rash, urticaria, FDEs, and erythema multiforme. The exact nature of drugs remained inaccessible in one-fourth cases due to use of the over-the-counter self-medications. The incidence of preventable and serious and fatal CADRs was 0.08% (95% CI: 0.05–0.11, 0.04% (95% CI: 0.02–0.06, and 0.003% (95% CI: 0.000–0.001, respectively. Conclusion: Ethnic characteristics should be considered while interpreting incidence from the international studies. The

  12. Acute adverse reactions to gadopentetate dimeglumine and gadobenate dimeglumine: experience with 32,659 injections.

    Science.gov (United States)

    Abujudeh, Hani H; Kosaraju, Vijaya K; Kaewlai, Rathachai

    2010-02-01

    The purpose of this study was to retrospectively assess the frequency, manifestations, and severity of acute adverse reactions associated with administration of two gadolinium-based contrast agents to patients who underwent MRI at a single large academic institution. Data from continuous quality assurance records on the number of administrations of and acute adverse reactions to gadopentetate dimeglumine and gadobenate dimeglumine at our institution October 2007 to December 2008 were tabulated and analyzed. During the investigation period, 32,659 administrations of gadolinium-based contrast agents were performed for MRI examinations. Of these, 27,956 administrations were gadopentetate dimeglumine, and 4,703 administrations were gadobenate dimeglumine. Data were collected on the frequency and severity of acute adverse reactions. A total of 51 acute adverse reactions occurred in 50 patients (16 men, 34 women; mean age, 48 years), accounting for 0.16% of all administrations (51/32,659). Thirty-eight reactions (38/27,956, 0.14%) were associated with gadopentetate dimeglumine, and 13 (13/4,703, 0.28%) were associated with gadobenate dimeglumine. Forty-three reactions were mild, six were moderate, and two were severe. The severe reactions occurred with the use of gadobenate dimeglumine. The rates of acute adverse reactions to gadopentetate dimeglumine and gadobenate dimeglumine were 0.14% and 0.28%, respectively. The overall adverse reaction rate was 0.16% in our patient sample. Direct comparison of adverse reaction rates of the two agents was not possible because of the retrospective uncontrolled study design.

  13. Analysis on 113 cases of adverse reactions caused by β-lactam antibiotics.

    Science.gov (United States)

    Lu, Jianquan; Cai, Chunyue; Gu, Yufeng; Tang, Yanhui; Xue, Jinbiao; Huang, Kaijian

    2013-01-01

    The objectives of this study were to learn about the characteristics and rules of the occurrence of adverse reactions caused by lactam antibiotics and provide a reference for clinical drug use. A retrospective study was made to analyse the 113 case reports of adverse reactions caused by β-lactam antibiotics collected in our hospital between 2007 and 2009. 113 cases of ADR involved 17 kinds of β-lactam antibiotics, headed by ceftriaxone sodium. The most common manifestation was skin and accessory damage; nervous system and gastrointestinal system damage were also easier to find, and the administration route was mainly intravenous infusion. The clinical application of β-lactam antibiotics should pay attention to adverse reaction monitoring and rational drug use to reduce the incidence of adverse reactions.

  14. Sex differences in cardiovascular drug-induced adverse reactions causing hospital admissions

    NARCIS (Netherlands)

    E.M. Rodenburg (Eline); B.H.Ch. Stricker (Bruno); L.E. Visser (Loes)

    2012-01-01

    textabstractAIMS Cardiovascular disease in women is often underestimated. The effects of cardiovascular drugs differ between the sexes because of pharmacokinetic and pharmacodynamic differences. Adverse drug reactions (ADRs) within these drug classes may have serious consequences, leading to

  15. Paediatric adverse drug reactions following use of asthma medications in Europe from 2007 to 2011

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2014-01-01

    Background Information about safety issues from use of asthma medications in children is limited. Spontaneous adverse drug reaction (ADR) reports can provide information about serious and rarely occurring ADRs in children. Objective To characterize paediatric ADRs reported for asthma medications...

  16. Shortening Isolation of Patients With Suspected Tuberculosis by Using Polymerase Chain Reaction Analysis

    DEFF Research Database (Denmark)

    Fløe, Andreas; Hilberg, Ole; Thomsen, Vibeke Østergaard

    2015-01-01

    Background. Isolation of patients suspected for pulmonary tuberculosis is guided by serial sputum smears. This can result in isolation for days for patients with noncontagious tuberculosis. To determine whether a single sample negative for Mycobacterium tuberculosis complex at polymerase chain re......-positive/PCR-negative cases underlines the importance of increasing the quantity and quality of samples. Moreover, it is important that samples analyzed with PCR are cultured, owing to higher-sensitivity drug susceptibility testing, differential diagnosis, and surveillance....

  17. Adverse reactions in a dose-ranging study with a new long-acting fluoroquinolone, fleroxacin.

    OpenAIRE

    Bowie, W R; Willetts, V; Jewesson, P J

    1989-01-01

    New fluoroquinolones have generally been well tolerated. In a double-blind evaluation of oral fleroxacin, using 400, 600, or 800 mg once daily for 7 days in an ambulatory setting for treatment of uncomplicated genital infections, we encountered unexpectedly high rates of adverse reactions. The objective of this analysis was to determine whether any factors in addition to dose could be found to account for our observations. Adverse reactions developed in 66 (84%) of 79 individuals, and severe ...

  18. Adverse Reactions in Allogeneic Blood Donors: A Tertiary Care Experience from a Developing Country

    OpenAIRE

    Sadia Sultan; Mohammad Amjad Baig; Syed Mohammed Irfan; Syed Ijlal Ahmed; Syeda Faiza Hasan

    2016-01-01

    Objectives: Fragmented blood transfusion services along with an unmotivated blood donation culture often leads to blood shortage. Donor retention is crucial to meet the increasing blood demand, and adverse donor reactions have a negative impact on donor return. The aim of this study was to estimate adverse donor reactions and identify any demographic association.   Methods: We conducted a prospective study between January 2011 and December 2013. A total of 41,759 healthy donors were enrol...

  19. Use of administrative hospital database to identify adverse drug reactions in a Pediatric University Hospital.

    Science.gov (United States)

    Durrieu, G; Batz, A; Rousseau, V; Bondon-Guitton, E; Petiot, D; Montastruc, J L

    2014-12-01

    The aim of the study was to detect adverse drug reactions (ADRs) in pediatric inpatients using the medical administrative database "Programme de Médicalisation des Systèmes d'Information" (PMSI) and to compare these cases ADRs with those spontaneously reported to a regional PharmacoVigilance (PV) Centre. The study was conducted from January 2008 to December 2011 in the Children University Hospital of Toulouse (Midi-Pyrénées, South-west France). From PMSI database, all discharge summaries including selected ICD-10 codes (10th International Classification of Diseases) were analyzed. All ADRs spontaneously reported by the Children Hospital of Toulouse and registered in the French PV Database (FPVDB) were included. The capture-recapture method was applied to estimate the incidence of ADRs. During the study period, we identified 60 reports from the PMSI database and 200 from the FPVDB. The rate of "serious" ADRs was higher in PMSI reports (74.6 % vs 38.9 %, p database versus cutaneous (22.4 %) and general (17.5 %) ADRs in FPVDB. The most frequently suspected drugs were antineoplastic drugs (31.1 %) in PMSI database versus anti-infectives (38.2 %) in FPVDB. The estimated number of ADRs was 717 [95 % confidence interval (CI) 513, 921], and the incidence of ADRs among admissions was 0.6 % (95 % CI 0.4, 0.8). Use of PMSI database improves from around 30 % detection of ADRs in children. In comparison with classical pharmacovigilance database, it also allows to detect different ADRs and drugs, thus enhancing safe medicine use for pediatric patients.

  20. Adverse drug reactions in hospital in-patients: a prospective analysis of 3695 patient-episodes.

    Directory of Open Access Journals (Sweden)

    Emma C Davies

    Full Text Available Adverse drug reactions (ADRs are a major cause of hospital admissions, but recent data on the incidence and clinical characteristics of ADRs which occur following hospital admission, are lacking. Patients admitted to twelve wards over a six-month period in 2005 were assessed for ADRs throughout their admission. Suspected ADRs were recorded and analysed for causality, severity and avoidability and whether they increased the length of stay. Multivariable analysis was undertaken to identify the risk factors for ADRs. The 5% significance level was used when assessing factors for inclusion in multivariable models. Out of the 3695 patient episodes assessed for ADRs, 545 (14.7%, 95% CI 13.6-15.9% experienced one or more ADRs. Half of ADRs were definitely or possibly avoidable. The patients experiencing ADRs were more likely to be older, female, taking a larger number of medicines, and had a longer length of stay than those without ADRs. However, the only significant predictor of ADRs, from the multivariable analysis of a representative sample of patients, was the number of medicines taken by the patient with each additional medication multiplying the hazard of an ADR episode by 1.14 (95% CI 1.09, 1.20. ADRs directly increased length of stay in 147 (26.8% patients. The drugs most frequently associated with ADRs were diuretics, opioid analgesics, and anticoagulants. In conclusion, approximately one in seven hospital in-patients experience an ADR, which is a significant cause of morbidity, increasing the length of stay of patients by an average of 0.25 days/patient admission episode. The overall burden of ADRs on hospitals is high, and effective intervention strategies are urgently needed to reduce this burden.

  1. Prospects of consumer-initiated adverse drug reaction reporting in cardiovascular pharmacovigilance

    Directory of Open Access Journals (Sweden)

    Vinu Wilson

    2015-01-01

    Full Text Available Drugs used for the treatment of cardiovascular disorders are frequently reported to cause adverse drug reactions (ADRs, second only to antimicrobials. ADRs strain the patients′ health and finances further and could prove fatal too. Pharmacovigilance programs aim to detect, monitor and understand ADRs in order to prevent them. Pharmacovigilance provides vital input to drug regulatory agencies to monitor safety of new as well as old drugs. Spontaneous reporting of suspected ADRs by healthcare professionals forms the backbone of pharmacovigilance programs worldwide including the Pharmacovigilance Program of India (PvPI launched in 2010. The PvPI has significantly contributed to strengthening pharmacovigilance in India but suffers from under-reporting of ADRs like similar programs worldwide. Consumer-initiated reporting of ADRs incorporated in pharmacovigilance programs of several countries has been found to decrease under-reporting rates besides supplementing traditional pharmacovigilance information. The PvPI has recently introduced the facility for consumers to report ADRs by contacting a hotline (1800-180-3024, through e-mail (pvpi.compat@gmail.com or by filling specifically designed ADR reporting forms, either in English language or vernacular translations, and submitting them to the nearest ADR monitoring centre. This is a welcome step in empowering patients as consumers of drugs with the mechanism to monitor their safety. It could potentially fill the huge gap in spontaneous ADR reporting and supplement the indigenous drug safety database with patients′ perspectives regarding ADRs e.g. effect on their quality of life. Whether it encourages rational prescription practices by doctors or enhances transparency regarding safety of investigational drugs in clinical trials needs to be seen.

  2. A value set for documenting adverse reactions in electronic health records.

    Science.gov (United States)

    Goss, Foster R; Lai, Kenneth H; Topaz, Maxim; Acker, Warren W; Kowalski, Leigh; Plasek, Joseph M; Blumenthal, Kimberly G; Seger, Diane L; Slight, Sarah P; Wah Fung, Kin; Chang, Frank Y; Bates, David W; Zhou, Li

    2017-12-14

    To develop a comprehensive value set for documenting and encoding adverse reactions in the allergy module of an electronic health record. We analyzed 2 471 004 adverse reactions stored in Partners Healthcare's Enterprise-wide Allergy Repository (PEAR) of 2.7 million patients. Using the Medical Text Extraction, Reasoning, and Mapping System, we processed both structured and free-text reaction entries and mapped them to Systematized Nomenclature of Medicine - Clinical Terms. We calculated the frequencies of reaction concepts, including rare, severe, and hypersensitivity reactions. We compared PEAR concepts to a Federal Health Information Modeling and Standards value set and University of Nebraska Medical Center data, and then created an integrated value set. We identified 787 reaction concepts in PEAR. Frequently reported reactions included: rash (14.0%), hives (8.2%), gastrointestinal irritation (5.5%), itching (3.2%), and anaphylaxis (2.5%). We identified an additional 320 concepts from Federal Health Information Modeling and Standards and the University of Nebraska Medical Center to resolve gaps due to missing and partial matches when comparing these external resources to PEAR. This yielded 1106 concepts in our final integrated value set. The presence of rare, severe, and hypersensitivity reactions was limited in both external datasets. Hypersensitivity reactions represented roughly 20% of the reactions within our data. We developed a value set for encoding adverse reactions using a large dataset from one health system, enriched by reactions from 2 large external resources. This integrated value set includes clinically important severe and hypersensitivity reactions. This work contributes a value set, harmonized with existing data, to improve the consistency and accuracy of reaction documentation in electronic health records, providing the necessary building blocks for more intelligent clinical decision support for allergies and adverse reactions.

  3. Iris and periocular adverse reactions to bimatoprost in Japanese patients with glaucoma or ocular hypertension

    Directory of Open Access Journals (Sweden)

    Inoue K

    2012-01-01

    Full Text Available Kenji Inoue1, Minako Shiokawa1, Michitaka Sugahara1, Risako Higa1, Masato Wakakura1, Goji Tomita21Inouye Eye Hospital, Tokyo, Japan; 2Second Department of Ophthalmology, Toho University School of Medicine, Tokyo, JapanPurpose: To prospectively investigate adverse reactions to bimatoprost in Japanese patients with glaucoma or ocular hypertension. We also examined patient attitudes to adverse reactions via a questionnaire.Methods: Fifty-two Japanese patients with glaucoma or ocular hypertension were enrolled. Iridial, eyelid, and eyelash photographs were taken before and at 6 months after bimatoprost treatment. Increase in eyelid pigmentation, iridial pigmentation, eyelash growth and bristle, and vellus hair of the lid was assessed from the photographs. Questionnaires completed by patients provided insight into their subjective judgment of adverse reactions.Results: Increase in eyelash bristle (53.8%, iris pigmentation (50.0%, eyelash growth (46.2%, vellus hair of the lid (40.4%, and eyelid pigmentation (7.7% was evident after bimatoprost treatment. The objective and subjective assessments were in agreement in terms of increase in eyelash bristle, eyelash growth, and increase in vellus hair of the lid.Conclusion: Most patients were conscious of these adverse reactions. Before administering bimatoprost, sufficient explanation of potential adverse reactions should be provided; after initiating treatment, careful observation is required.Keywords: bimatoprost, adverse reaction, eyelid pigmentation, changes in eyelashes, iris pigmentation 

  4. Adverse Reactions in Allogeneic Blood Donors: A Tertiary Care Experience from a Developing Country.

    Science.gov (United States)

    Sultan, Sadia; Baig, Mohammad Amjad; Irfan, Syed Mohammed; Ahmed, Syed Ijlal; Hasan, Syeda Faiza

    2016-03-01

    Fragmented blood transfusion services along with an unmotivated blood donation culture often leads to blood shortage. Donor retention is crucial to meet the increasing blood demand, and adverse donor reactions have a negative impact on donor return. The aim of this study was to estimate adverse donor reactions and identify any demographic association.  . We conducted a prospective study between January 2011 and December 2013. A total of 41,759 healthy donors were enrolled. Professionally trained donor attendants drew blood and all donors were observed during and following donation for possible adverse events for 20 minutes. Blood donors were asked to report if they suffered from any delayed adverse consequences.  . Out of 41,759 blood donors, 537 (1.3%) experienced adverse reactions. The incidence was one in every 78 donations. The mean age of donors who experienced adverse events was 26.0±6.8 years, and all were male. Out of 537 donors, 429 (80%) developed vasovagal reaction (VVR), 133 (25%) had nausea, 63 (12%) fainted, 35 (6%) developed hyperventilation, 9 (2%) had delayed syncope, and 9 (2%) developed hematoma. Arterial prick, nerve injury, cardiac arrest, and seizures were not observed. Donors aged less than donors also had a significant association with fainting and nausea, respectively (p adverse events was low at our tertiary center. A VVR was the predominant adverse reaction and was associated with age and weight. Our study highlights the importance of these parameters in the donation process. A well-trained and experienced phlebotomist and pre-evaluation counseling of blood donors could further minimize the adverse reactions.

  5. Adverse Reactions in Allogeneic Blood Donors: A Tertiary Care Experience from a Developing Country

    Directory of Open Access Journals (Sweden)

    Sadia Sultan

    2016-03-01

    Full Text Available Objectives: Fragmented blood transfusion services along with an unmotivated blood donation culture often leads to blood shortage. Donor retention is crucial to meet the increasing blood demand, and adverse donor reactions have a negative impact on donor return. The aim of this study was to estimate adverse donor reactions and identify any demographic association.   Methods: We conducted a prospective study between January 2011 and December 2013. A total of 41,759 healthy donors were enrolled. Professionally trained donor attendants drew blood and all donors were observed during and following donation for possible adverse events for 20 minutes. Blood donors were asked to report if they suffered from any delayed adverse consequences.   Results: Out of 41,759 blood donors, 537 (1.3% experienced adverse reactions. The incidence was one in every 78 donations. The mean age of donors who experienced adverse events was 26.0±6.8 years, and all were male. Out of 537 donors, 429 (80% developed vasovagal reaction (VVR, 133 (25% had nausea, 63 (12% fainted, 35 (6% developed hyperventilation, 9 (2% had delayed syncope, and 9 (2% developed hematoma. Arterial prick, nerve injury, cardiac arrest, and seizures were not observed. Donors aged less than < 30 years and weighing < 70 kg were significantly associated with VVR, hyperventilation, and nausea (p < 0.005. Undergraduates and Urdu speaking donors also had a significant association with fainting and nausea, respectively (p < 0.05.   Conclusion: The prevalence of adverse events was low at our tertiary center. A VVR was the predominant adverse reaction and was associated with age and weight. Our study highlights the importance of these parameters in the donation process. A well-trained and experienced phlebotomist and pre-evaluation counseling of blood donors could further minimize the adverse reactions.

  6. Adverse reactions to blood donations: the READ project

    Science.gov (United States)

    Garozzo, Giovanni; Crocco, Isabella; Giussani, Barbara; Martinucci, Annalisa; Monacelli, Stefano; Randi, Vanda

    2010-01-01

    Background In 2006 in Italy 2,404,267 donations of blood components were made by 1,539,454 donors; approximately 55% of the donations were collected directly by Transfusion Structures (TS), while about 45% were collected in Donation Centres managed by Associations and Federations of Donors. The aim of the READ (Rilevamento Eventi Avversi alla Donazione) project is to create a network of TS to test a standardised system for monitoring adverse events (AE) related to blood donations. Materials and methods Shared, standardised data collection forms, compatible with the forms produced by the ISBT-EHN, were prepared. Two types of form were used: (i) a form to collect data on single events (READ 1), to be used at the individual collection sites; (ii) a form for processing the data collected by each TS (READ 2). Results Between February and August 2008 six TS collected data related to the donation of 89,332 units of blood. Overall, 523 AE were recorded. The AE occurred in 0.59% of the donations. The mean duration of the symptoms was 17 minutes. Fifteen percent of the symptoms were related to the venipuncture (mainly haematomas) and 77% to vasovagal AE. The AE were defined severe (grade C) in 47 cases. The donations in which AE were recorded were completed in 81% of the cases; 59% of the AE did not require treatment. Three donors were monitored briefly (for less than 4 hours) in hospital. Conclusions The use of standardised forms enabled the collection of data that could be analysed. Some problems related to the performance of the haemovigilance programme did, however, emerge: (i) organisational problems, (ii) limited sensitivity, (iii) inadequate training, and (iv) poorly defined responsibilities. These problems must be resolved at various levels: local, regional and national. PMID:20104279

  7. Adverse reactions to blood donations: the READ project.

    Science.gov (United States)

    Garozzo, Giovanni; Crocco, Isabella; Giussani, Barbara; Martinucci, Annalisa; Monacelli, Stefano; Randi, Vanda

    2010-01-01

    In 2006 in Italy 2,404,267 donations of blood components were made by 1,539,454 donors; approximately 55% of the donations were collected directly by Transfusion Structures (TS), while about 45% were collected in Donation Centres managed by Associations and Federations of Donors. The aim of the READ (Rilevamento Eventi Avversi alla Donazione) project is to create a network of TS to test a standardised system for monitoring adverse events (AE) related to blood donations. Shared, standardised data collection forms, compatible with the forms produced by the ISBT-EHN, were prepared. Two types of form were used: (i) a form to collect data on single events (READ 1), to be used at the individual collection sites; (ii) a form for processing the data collected by each TS (READ 2). Between February and August 2008 six TS collected data related to the donation of 89,332 units of blood. Overall, 523 AE were recorded. The AE occurred in 0.59% of the donations. The mean duration of the symptoms was 17 minutes. Fifteen percent of the symptoms were related to the venipuncture (mainly haematomas) and 77% to vasovagal AE. The AE were defined severe (grade C) in 47 cases. The donations in which AE were recorded were completed in 81% of the cases; 59% of the AE did not require treatment. Three donors were monitored briefly (for less than 4 hours) in hospital. The use of standardised forms enabled the collection of data that could be analysed. Some problems related to the performance of the haemovigilance programme did, however, emerge: (i) organisational problems, (ii) limited sensitivity, (iii) inadequate training, and (iv) poorly defined responsibilities. These problems must be resolved at various levels: local, regional and national.

  8. The fourteenth report on survey of adverse reaction to radiopharmaceuticals; The 17th survey in 1991

    Energy Technology Data Exchange (ETDEWEB)

    1993-05-01

    This report deals with adverse reactions to radiopharmaceuticals occurring during the period from April 1, 1991 through March 31, 1992. Questionnaires were sent to 1,150 facilities, and 906 (78.8%) responded. Twenty one cases of adverse reactions and 7 cases of drug defects were reported from a total of 19 facilities (2.1%), giving an annual incidence of 2.0 and 0.7 cases, respectively, for 100,000 administered cases. The ratio of the occurrence in the 17th survey to that in the 16th survey was 1.18 for adverse reactions and 0.39 for drug defects. The occurrence of drug defects in this survey was lowest compared with that in the previous five surveys. According to radiopharmaceuticals, the incidence of adverse reactions was as follows: I-131-6[beta]-iodomethyl-19-norcholesterol>I-123 orthoiodohippurate>I-131 orthoiodohippurate>Tc-99m DMSA>Tc-99m DTPA>Tc-99m MAA>Ga-67 citrate>Tc-99m MDP>Tc-99m HMDP. Adverse reactions included reactions to the vagus nerves (n=9), allergic reactions (n=3), and others (n=9). Radiopharmaceuticals reported as drug defects were as follows: Tc-99m pertechnetate, Tc-99m MDP, Tc-99m HMDP, Tc-99m phytate, and Tl-201 chloride. (N.K.).

  9. Adverse drug reaction reports for cardiometabolic drugs from sub-Saharan Africa: a study in VigiBase.

    Science.gov (United States)

    Berhe, Derbew Fikadu; Juhlin, Kristina; Star, Kristina; Beyene, Kidanemariam G M; Dheda, Mukesh; Haaijer-Ruskamp, Flora M; Taxis, Katja; Mol, Peter G M

    2015-06-01

    Identifying key features in individual case safety reports (ICSR) of suspected adverse drug reactions (ADRs) with cardiometabolic drugs from sub-Saharan Africa (SSA) compared with reports from the rest of the world (RoW). Reports on suspected ADRs of cardiometabolic drugs (ATC: A10[antidiabetic], B01[antithrombotics] and C[cardiovascular]) were extracted from WHO Global database, VigiBase(®) (1992-2013). We used vigiPoint, a logarithmic odds ratios (log2 OR)-based method to study disproportional reporting between SSA and RoW. Case-defining features were considered relevant if the lower limit of the 99% CI > 0.5. In SSA, 3773 (9%) of reported ADRs were for cardiometabolic drugs, in RoW for 18%. Of these, 79% originated from South Africa and 81% were received after 2007. Most reports were for drugs acting on the renin-angiotensin system (36% SSA & 14% RoW). Compared with RoW, reports were more often sent for patients 18-44 years old (log2 OR 0.95 [99 CI 0.80; 1.09]) or with non-fatal outcome (log2 OR 1.16 [99 CI 1.10; 1.22]). Eight ADRs (cough, angioedema, lip swelling, face oedema, swollen tongue, throat irritation, drug ineffective and blood glucose abnormal) and seven drugs (enalapril, rosuvastatin, perindopril, vildagliptin, insulin glulisine, nifedipine and insulin lispro) were disproportionally more reported in SSA than in the RoW. 'In recent years, the number of adverse drug reactions (ADRs) reported in Sub-Saharan Africa (SSA) has sharply increased. The data showed the well-known population-based differential ADR profile of ACE inhibitors in the SSA population.' © 2015 John Wiley & Sons Ltd.

  10. A systematic review of observational studies evaluating costs of adverse drug reactions

    Directory of Open Access Journals (Sweden)

    Batel Marques F

    2016-08-01

    ,192.36.Discussion: Methodological heterogeneities were identified among the included studies, such as design, type of ADEs, suspected drugs, and type and structure of costs. Despite such discrepancies, the financial burden associated with ADE costs was found to be high. In the light of the present findings, validated methods to measure ADE-associated costs need future research efforts. Keywords: drug costs, health care costs, drug-related side effects and adverse reactions, review

  11. Evaluation of polymerase chain reaction using primer MPB 64 for diagnosis of clinically suspected cases of extrapulmonary tuberculosis

    Directory of Open Access Journals (Sweden)

    Dnyaneshwari P. Ghadage

    2014-01-01

    Full Text Available Background: Pulmonary tuberculosis can be easily diagnosed by simple techniques such as microscopy. However, extrapulmonary tuberculosis (EPTB often presents a diagnostic dilemma. Microscopy and culture have proved to be insensitive techniques for diagnosis of EPTB. There is an urgent need for rapid and sensitive diagnostic methods. Aim: The present study was conducted to evaluate the role of polymerase chain reaction (PCR in the early diagnosis of clinically suspected cases of EPTB. Materials and Methods: A total of 80 clinical specimens comprising pleural fluid, cerebrospinal fluid, ascitic fluid, fine-needle aspiration biopsy, and pus and biopsy from clinically suspected EPTB cases were processed and followed up by conventional methods and PCR using MPB64 primer. Results: Tuberculous pleural effusion (71% was found to be the most common clinical presentation of EPTB. Overall, PCR could detect EPTB in 61.2% cases. Microscopy and culture could detect 18.7% and 22.5% EPTB cases, respectively. PCR was positive in all tissue samples suggestive of tuberculosis on histopathological examination. Of the 62 EPTB patients who responded to antituberculosis treatment (ATT, 49 patients were PCR positive. Conclusion: PCR using MPB64 had a significant advantage over the conventional methods to detect the presence of M. tuberculosis in specimens of clinically suspected EPTB patients for early diagnosis of tuberculosis.

  12. Bacterial Infection as a Likely Cause of Adverse Reactions to Polyacrylamide Hydrogel Fillers in Cosmetic Surgery

    NARCIS (Netherlands)

    Christensen, Lise; Breiting, Vibeke; Bjarnsholt, Thomas; Eickhardt, Steffen; Høgdall, Estrid; Janssen, Martin; Pallua, Norbert; Zaat, Sebastian A. J.

    2013-01-01

    Background. The etiology of long-lasting adverse reactions to gel fillers used in cosmetic surgery is not known. Bacterial infection and immunological reaction to the product have been suggested. Methods. We performed a case-control study, with 77 biopsies and 30 cytology specimens originating from

  13. Long term adverse drug reaction to Efavirenz in a HIV infected ...

    African Journals Online (AJOL)

    Efavirenz is one of the medications used in combined antiretroviral therapy (ART) for the management of HIV infection in adolescents. Various central nervous system adverse reactions have been reported in patients commencing antiretroviral therapy with a regimen containing Efavirenz. These reactions tend to be acute, ...

  14. Assessment of adverse reaction rates during gadoteridol-enhanced MR imaging in 28,078 patients.

    Science.gov (United States)

    Morgan, Desiree E; Spann, J Stephen; Lockhart, Mark E; Winningham, Beth; Bolus, David N

    2011-04-01

    To determine adverse reaction rates in a tertiary care clinical setting after adoption of gadoteridol as the institutional routine magnetic resonance (MR) imaging contrast agent. With institutional review board approval, informed consent waiver, and HIPAA compliance, a prospective observational study of 28 078 patients who underwent intravenous gadoteridol-enhanced MR imaging from July 2007 to December 2009 was performed. Reactions were recorded by technologists who noted types of reactions, method of injection, and treatment. Reactions were classified as mild, moderate, or severe per American College of Radiology definitions. Comparisons of reaction rates with dose and method of injection were analyzed with the Fisher exact and χ(2) tests. Overall reaction rate was 0.666% (187 patients), including 177 mild, six moderate, and four severe reactions. Treatment was given in 27 patients (14.4%). The most frequent reaction was nausea (and/or vomiting) in 149 patients (79.7% of patients with any adverse reaction, 0.530% of overall population). Method of injection did not affect reaction rate or severity. There was no difference in type or severity of reactions in comparison of patients receiving half the dose versus patients receiving the standard dose (P = .33-.75). The observed adverse reaction rate to gadoteridol was lower than previously reported. Specifically, the rate of nausea (0.530%) was less than half the rate (1.4%) in clinical trials of 1251 patients, leading to FDA approval in 1992. Rates of adverse reactions for this macrocyclic contrast agent are comparable to those published for linear gadolinium-based contrast agents. © RSNA, 2011.

  15. A Retrospective Analysis of Spontaneous Adverse Drug Reactions Reports Relating to Paediatric Patients.

    Directory of Open Access Journals (Sweden)

    Rosliana Rosli

    Full Text Available Spontaneous reporting on adverse drug reactions (ADR has been established in Malaysia since 1987, and although these reports are monitored by the Malaysia drug monitoring authority, the National Pharmaceutical Control Bureau, information about ADRs in the paediatric patient population still remains unexplored. The aims of this study, therefore, were to characterize the ADRs reported in respect to the Malaysian paediatric population and to relate the data to specific paediatric age groups.Data on all ADRs reported to the National Pharmaceutical Control Bureau between 2000 and 2013 for individuals aged from birth to 17 years old were analysed with respect to age and gender, type of reporter, suspected medicines (using the Anatomical Therapeutic Chemical classification, category of ADR (according to system organ class as well as the severity of the ADR.In total, 11,523 ADR reports corresponding to 22,237 ADRs were analysed, with half of these reporting one ADR per report. Vaccines comprised 55.7% of the 11,523 ADR reports with the remaining being drug related ADRs. Overall, 63.9% of ADRs were reported for paediatric patients between 12 and 17 years of age, with the majority of ADRs reported in females (70.7%. The most common ADRs reported were from the following system organ classes: application site disorders (32.2%, skin and appendages disorders (20.6%, body as a whole general disorders (12.8% and central and peripheral nervous system disorders (11.2%. Meanwhile, ADRs in respect to anti-infectives for systemic use (2194/5106; 43.0% were the most frequently reported across all age groups, followed by drugs from the nervous system (1095/5106; 21.4%. Only 0.28% of the ADR cases were reported as fatal. A large proportion of the reports were received from healthcare providers in government health facilities.ADR reports concerning vaccines and anti-infectives were the most commonly reported in children, and are mainly seen in adolescents, with most of

  16. Tenth report on survey of the adverse reaction to radiopharmaceuticals. The 13th survey in 1987

    Energy Technology Data Exchange (ETDEWEB)

    1989-04-01

    The 13th questionnaire survey was performed for adverse reaction to radiopharmaceuticals occuring during one year from April 1987 through March 1988. A questionnaire was sent to 1,063 facilities. Seven hundred and sixty-nine replies (72%) were received. Twenty-one cases of adverse reaction and 11 cases of drug defect were reported from 23 facilities (3.0%), giving annual incidences of 2.4 and 1.3, respectively, per 100,000 administrations. The ratio of the 1987's incidence to the 1986's incidence was 0.78 for adverse reaction and 0.96 for drug defect. The incidence of adverse reaction decreased from 0.0060-0.0061% during the period between 1983 and 1984 to 0.0037-0.0045% during the period between 1985 and 1987. The incidence of adverse reaction was highest for I-131 Adosterol (191/100,000), followed by Tc-99m DTPA (14/100,000), I-131 Hippuran (13/100,000), Tc-99m DMSA (7/100,000), pyrophosphate for labeling red blood cells (6/100,000), Tc-99m MAA (4/100,000), Tc-99m HMDP (1/100,000), and Ga-67 citrate (0.8/100,000). Adverse reactions included: reactions to the vagus nerves (n=9), allergic reaction (n=8), and others, including dyspnea and vomiting (n=4). Drug defects occurred in 6 cases of Tc-99m MDP, 2 cases of Tc-99m HMDP, one case of Tc-99m MAA, one case of Tc-99m DTPA, and one case of I-131 sodium iodinate capsule. (Namekawa, K).

  17. [Delayed adverse reactions to blood donation: From haemovigilance data to specific studies].

    Science.gov (United States)

    Py, J-Y; Durieux, S; Barnoux, M; Sapey, T

    2016-11-01

    Delayed adverse reactions to blood donation occur after the donor left donation site. Their intrinsic gravity and possible complications can be increased by the fact the donor is alone. This can also increase bad memories, leading to a donation giving up. Blood transfusion centre is only aware in case of donor feedback, hence an event underrating. We choose to compare our data upon delayed adverse donor reactions with those we could find in past studies. A first data level comes from French haemovigilance data while serious adverse reactions declaration is mandatory. But a second level can be reached using blood transfusion centre computerized data because all the donation reactions are saved whatever the gravity is. In both cases, delayed reactions are only those reported by donors. We try to make an exhaustive search of specific studies upon the real delayed reactions incidence so as to compare with our data. There were 1957 serious adverse reactions declared in our regional haemovigilance database between 2011 and 2015: 49 % occurring during donation, 40 % after it but before donor departure, and 11 % delayed events. There were 16,050 adverse reactions recorded during the first trimester of 2016 in mainland France, with 2.7 % delayed ones. Proportion of delayed events rises when gravity rises, until 27.6 % for the most serious ones. It varies between 2.2 % and 2.7 % for vasovagal reactions, haematomas, and other local reactions, and reaches 16.2 % for other general reactions. Data found in other studies with a spontaneous donor notification are of the same kind. But four studies soliciting specifically donor notification give a dramatically higher delayed reactions incidence, with an understatement greater than three out of four. Moreover, these studies found a majority of delayed reactions, which are not included in haemovigilance like fatigue or bruising. Occurrence of a delayed donor reaction is clearly underrated in standard haemovigilance. It

  18. Drug related medical emergencies in the elderly: role of adverse drug reactions and non-compliance.

    Science.gov (United States)

    Malhotra, S; Karan, R S; Pandhi, P; Jain, S

    2001-11-01

    Adverse drug reactions and non-compliance are important causes of admissions in the elderly to medical clinics. The contribution of adverse drug reactions and non-compliance to admission by the medical emergency department was analysed. A total of 578 consecutive elderly patients admitted to the medical emergency department were interviewed to determine the percentage of admissions due to adverse drug reactions or non-compliance with medication regimens, their causes, consequences, and predictors. Eighty three (14.4%) of the 578 admissions were drug related: 39 (6.7%) caused by adverse drug reactions and 44 (7.6%) caused by non-compliance with medication. One hundred ninety two (33.2%) patients had a history of non-compliance. Factors associated with an increased risk of admission because of an adverse drug reaction were patients with diabetes or neoplasms, and patients using numerous different medications. Factors associated with a higher risk of hospitalisation because of non-compliance were poor recall of the medication regimen, seeing numerous physicians, female sex, polypharmacy, drug costs, and switching over to non-conventional forms of treatment. Many elderly admissions are drug related, with non-compliance accounting for a substantial fraction of these. Elderly people at high risk of suffering a drug related medical emergency are identified and suitable interventions may be planned by the healthcare policymakers to target them.

  19. Epidemiology of adverse reactions to carbamazepine as seen in a spontaneous reporting system.

    Science.gov (United States)

    Askmark, H; Wiholm, B E

    1990-02-01

    A survey was made of 505 reports on 713 adverse reactions to carbamazepine submitted to the Swedish Adverse Drug Reactions Advisory Committee from 1965-1987. For the period after 1972, the relation between the reports and sales statistics could be investigated. The total incidence of reported adverse reactions to carbamazepine was 4.5 per million defined daily doses (DDD), corresponding to 2.7 per million prescribed daily doses (PDD). Most often reported were skin reactions (48%), but reports on haematological (12%) and hepatic disorders (10%) were also frequent. Virtually all hepatic disorders and severe skin reactions, as well as the majority (60%) of the haematological reactions, occurred within the first 2 months of treatment. In view of the very low incidence of reported serious blood dyscrasias, such as pancytopenia (0.04/million PDD) and agranulocytosis (0.06/million PDD), continuous haematological monitoring seems to be of little value. The elderly appear to be at increased risk of developing blood dyscrasias and liver reactions, and alcohol abusers seem to represent a high-risk group for developing serious skin reactions.

  20. Eighth report on survey of the adverse reaction to radiopharmaceuticals. 11th survey in 1985

    Energy Technology Data Exchange (ETDEWEB)

    1987-04-01

    Adverse reactions to radiopharmaceuticals occurring in the past one year from April 1, 1985 through March 31, 1986 are reported. Questionnaires were sent to 1,003 facilities, and 72% (722) responded. Twenty-seven adverse reactions and 9 drug defects were reported from a total of 29 facilities, giving an annual incidence of 2.7/100,000 and 0.9/100,000, respectively. The incidence of adverse reactions to I-131-6..beta..-iodomethyl-19-norcholesterol was the highest (242/100,000), followed by I-131 sodium iodohippurate (16/100,000), Tc-99m diethylenetriamine-pentaacetic acid (10/100,000), Ga-67 citrate (2/100,000), and Tc-99m pyrophosphate (2/100,000). Common adverse reactions included (a) reactions to the vagus nerves (n = 17), such as nausea, palpitation, and hypotension; (b) allergic reactions (n = 5), such as redness, itching, and dyspnea; and (c) others (n = 5), including back pain and tongue numbness. There was no fever. Radiopharmaceuticals reported as poor quality (drug defects) were Tc-99m Sn colloid, Tc-99m methylene diphosphonate, Tc-99m phytate, and Tc-99m generator. (Namekawa, K.).

  1. ASSOCIATION BETWEEN CARBAMAZEPINE INDUCED SEVERE CUTANEOUS ADVERSE DRUG REACTION AND HLA POLIMORPHISMS

    Directory of Open Access Journals (Sweden)

    Safrina Dewi Ratnaningrum

    2016-01-01

    Full Text Available Carbamazepine as an antiepileptic drug that is used widely and was known can cause severe cutaneous adverse drug reactions like SJS-TEN. These adverse drug reactions is known to be associated with some specific HLA polymorphism in European populations (HLA-A*31: 01, China (HLA-A*31: 01; HLA-B*15:02, Japan (HLA-A*31 : 01; HLA-B*15: 11, Korea HLA-A*31: 01; HLA-B*15: 02; HLA-B*15: 11, India (HLA-B*15:02, Thailand (HLA-B*15: 02, and Malaysia (HLA-B*15: 02. Information related to certain HLA polymorphism is important to prevent adverse drug reaction but there is no sufficient data on the population of Indonesia.

  2. DL-ADR: a novel deep learning model for classifying genomic variants into adverse drug reactions

    OpenAIRE

    Liang, Zhaohui; Huang, Jimmy Xiangji; Zeng, Xing; Zhang, Gang

    2016-01-01

    Background Genomic variations are associated with the metabolism and the occurrence of adverse reactions of many therapeutic agents. The polymorphisms on over 2000 locations of cytochrome P450 enzymes (CYP) due to many factors such as ethnicity, mutations, and inheritance attribute to the diversity of response and side effects of various drugs. The associations of the single nucleotide polymorphisms (SNPs), the internal pharmacokinetic patterns and the vulnerability of specific adverse reacti...

  3. Adverse Reactions Associated With Cannabis Consumption as Evident From Search Engine Queries.

    Science.gov (United States)

    Yom-Tov, Elad; Lev-Ran, Shaul

    2017-10-26

    Cannabis is one of the most widely used psychoactive substances worldwide, but adverse drug reactions (ADRs) associated with its use are difficult to study because of its prohibited status in many countries. Internet search engine queries have been used to investigate ADRs in pharmaceutical drugs. In this proof-of-concept study, we tested whether these queries can be used to detect the adverse reactions of cannabis use. We analyzed anonymized queries from US-based users of Bing, a widely used search engine, made over a period of 6 months and compared the results with the prevalence of cannabis use as reported in the US National Survey on Drug Use in the Household (NSDUH) and with ADRs reported in the Food and Drug Administration's Adverse Drug Reporting System. Predicted prevalence of cannabis use was estimated from the fraction of people making queries about cannabis, marijuana, and 121 additional synonyms. Predicted ADRs were estimated from queries containing layperson descriptions to 195 ICD-10 symptoms list. Our results indicated that the predicted prevalence of cannabis use at the US census regional level reaches an R 2 of .71 NSDUH data. Queries for ADRs made by people who also searched for cannabis reveal many of the known adverse effects of cannabis (eg, cough and psychotic symptoms), as well as plausible unknown reactions (eg, pyrexia). These results indicate that search engine queries can serve as an important tool for the study of adverse reactions of illicit drugs, which are difficult to study in other settings.

  4. Common and uncommon adverse cutaneous reactions to erlotinib: a study of 20 Chinese patients with cancer.

    Science.gov (United States)

    Zhu, Huiling; Zhu, Zhe; Huang, Weining; Cheng, Xiping; He, Jiaxi; Xiong, Chunping; Han, Jiande

    2018-03-01

    This study presented common lesions with systemic toxicities and uncommon adverse cutaneous reactions such as anaphylactic dermatitis in patients undergoing treatment with erlotinib for the benefit of practicing dermatologists and oncologists. Adverse cutaneous reactions associated with erlotinib were reported in 20 Chinese patients with cancer. Adverse cutaneous reactions reported included six cases of anaphylactic dermatitis, 12 cases of acneiform rash, nine cases of xerosis, five cases of nail changes and four cases of hair changes. One case of anaphylactic dermatitis manifested as erythema with swelling on the face and neck, and others as erosive and scaly erythema on the fold of skin, or red macules, papules, plaques and pigmentation on the whole body. Clinical details indicated anaphylactic reactions, including a high percentage of eosinophils in the peripheral blood, eosinophilic infiltration in the dermis layer and good response to antihistamines and topical steroids. Systemic toxicities accompanied by cutaneous reactions occurred in five patients including one case of anaphylactic dermatitis and four cases of acneiform rash. Elevated hepatic enzymes were observed among all the patients with grade-3 or grade-4 acneiform rashes. One patient with anaphylactic dermatitis and one with acneiform rash discontinued erlotinib administration due to severe lesions, high fever or severe elevation of hepatic enzymes. Anaphylactic cutaneous reactions caused by erlotinib are rarely described hitherto. Systemic toxicities should be emphasized especially in cases with severe skin disorders. Timely detection and appropriate early intervention in patients who develop severe cutaneous reaction while on erlotinib therapy should be considered clinically.

  5. A case of dysgraphia induced by sertraline and a review of official spontaneous adverse reaction databases.

    Science.gov (United States)

    Gentili, M; Marinaccio, P M; Galimberti, C; Carnovale, C; Antoniazzi, S; Pozzi, M; Clementi, E; Viganò, C; Radice, S

    2016-02-01

    The occurrence of dysgraphia after sertraline intake has never been reported. The objective was to describe a case of this adverse drug reaction and present a review of similar cases held in international databases with a discussion of the possible pharmacological mechanisms. We observed a 60-year-old man who experienced resting tremors, dyskinesia and dysgraphia 2 months after a stepwise increase in sertraline dosing from 50 to 200 mg/day. Dysgraphia is a possible adverse drug reaction to sertraline, and we suggest that inhibition of extrapyramidal dopaminergic activity might be the pharmacological mechanism. © 2016 John Wiley & Sons Ltd.

  6. Adverse drug reactions: 'six rights' to ensure best practice for children.

    Science.gov (United States)

    Kanneh, Agnes

    2011-06-01

    In the second of a two-part article on adverse drug reactions Agnes Kanneh describes the six 'rights' of the recipient of a drug. These are: that the right person should receive the right drug, in the right dose, at the right time within the right intervals, via the right route, followed by the right (correct) documentation. The author argues that the observance of these 'rights' by children's nurses ensures the best pharmacotherapeutic practice, thus a robust practical safeguard in adverse drug reactions and threats to the good reputation of the nursing profession.

  7. Adverse Reactions of Trivalent Influenza Vaccine in HIV-Infected Individuals

    Directory of Open Access Journals (Sweden)

    Mahboube Hajiabdolbaghi

    2010-03-01

    Full Text Available In this study, we assessed the adverse reactions to influenza vaccination in HIV- infected individuals. From November 2006 to January 2007, a total of 203 HIV-infected persons were recruited. Demographic data were collected. Subjects were evaluated 48 h and 15 days after vaccination for symptoms and significant health events as possible side effects. Participants were instructed to measure their temperature in the morning and evening for 2 days post-immunization and to assess injection site and systemic adverse reactions. 80.3% of the subjects were male. The mean age of the subjects was 36.9±7.9 years. Local and systemic reactions were reported by 61 (30% and 62 (30.5% persons, respectively. The most common adverse reactions to the influenza vaccine included skin redness (37 cases, induration (32 cases, and pain (55 cases as local reac-tions, and fever (22 cases, myalgia (46 cases, headache (12 cases and weakness (35 cases as general reactions. 1.4 % of the subjects had fever over 38.5 ºC. There were significant associations between myalgia and flushing with CD4 counts (P<0.05. We found no relationship between ad-verse reactions and sex, history of smoking, allergy, alcohol, and drug usage, stage of HIV infec-tion, anti-retroviral therapies, anti-TB medication and previous vaccination. We concluded that inactivated influenza vaccine administered in HIV-infected adults did not result in potential ad-verse events in this study population.

  8. Report on survey of the adverse reaction to radiopharmaceuticals. 16. The 19th survey in 1993

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-06-01

    This report deals with adverse reactions to radiopharmaceuticals occurring during the period from April 1, 1993 through March 31, 1994. Questionnaires were sent to 1,176 facilities, and 904 (76.9%) responded. A total of 8 cases of adverse reactions and 16 cases of drug defect were reported from 22 (2.4%) of the 904 facilities, giving an annual occurrence of 0.7 and 1.4 cases, respectively, for 100,000 examinations. The present data provided the lowest incidence of adverse reactions, compared with the previous data for 5 years. The incidence of drug defect also tended to be decreased. The incidence of adverse reactions for a total of 904 facilities was the highest for I-131-6{beta}-iodomethyl-19-norcholesterol (n=34), followed by {sup 99m}Tc-MIBI (n=16), {sup 99m}Tc-DTPA (n=4), {sup 99m}Tc-HM-PAO (n=4), {sup 99m}Tc-MAA (n=3), and {sup 201}Tl-chloride (n=1). Adverse reactions included reactions to the vagus nerves (n=4), allergic reactions (n=3), and others (n=1). Radiopharmaceutical reported as drug defect were as follows: {sup 99}Mo-{sup 99m}Tc-generator, {sup 99m}Tc-phytate, {sup 99m}Tc-HMDP, {sup 99m}DMSA, {sup 99m}Tc-HM-PAO, {sup 67}Ga citrate, {sup 123}I-BMIPP, {sup 131}I-sodium iodide capsule for treatment, {sup 111}In-iridium chloride, and {sup 133}Xe-xenogas. (N.K.).

  9. Adverse drug reactions to antiretroviral therapy: Results from spontaneous reporting system in Nigeria

    Directory of Open Access Journals (Sweden)

    Kenneth A Agu

    2013-01-01

    Full Text Available Aim: This study evaluated the suspected adverse drug reactions (ADR reported from a spontaneous reporting program in Human Immunodeficiency Virus (HIV positive patients receiving antiretroviral therapy (ART in Nigeria Materials and Methods: This descriptive study analyzed individual case safety reports (ICSRs in HIV-positive patients receiving ART between January 2011 and December 2011 in 38 secondary hospitals. All ICSRs during this period were included. Chi-square was used to test the association between variables at 95% confidence interval. Results: From 1237 ICSRs collated, only 1119 (90.5% were valid for analysis. Mean age of patients was 35.3 (95%CI, 35.1-35.5 years; and 67.1% were females. A total of 1679 ADR cases were reported, a mean (± Standard Deviation, SD of 1.5 (± 0.8 ADR cases per patient. Of reported ADRs, 63.2%, 8.2% and 19.3% occurred in patients on Zidovudine-based, Stavudine-based and Tenofovir-based regimens, respectively. The commonest ADRs included (12.0% peripheral neuropathy, (11.4% skin rash, (10.1% pruritus and (6.5% dizziness. ADR occurrence was associated with ART regimens, concomitant medicines and age (P < 0.05 unlike gender. Anaemia was associated with Zidovudine (AZT/ Lamivudine (3TC /Nevirapine (NEV regimen [Odds ratio, OR = 6.4 (3.0-13.8; P < 0.0001], and peripheral neuropathy with Stavudine (d4T/3TC/NEV regimen [OR = 8.7 (5.8-30.0, P < 0.0001] and Tenofovir (TDF/Emtricitabine (FTC/Efavirenz (EFV regimen [OR = 2.1 (1.0-4.1, P = 0.0446]. Skin rash and peripheral neuropathy were associated with patients aged < 15years [OR = 3.0 (1.3-6.6, P = 0.0056] and 45-59years [OR = 1.9 (1.3-2.7, P = 0.0006] respectively. Palpitation and polyuria were associated with Salbutamol [OR = 55.7 (4.9-349.6, P = 0.0000] and Nonsteroidal anti-inflammatory drugs (NSAIDS [OR = 50.2 (0.9-562.1, P = 0.0040] respectively. Conclusion: ADRs were less likely to occur in patients on stavudine-based and tenofovir-based regimens compared to

  10. Pattern of adverse drug reactions reported by the community pharmacists in Nepal

    Directory of Open Access Journals (Sweden)

    Palaian S

    2010-09-01

    Full Text Available The pharmacovigilance program in Nepal is less than a decade old, and is hospital centered. This study highlights the findings of a community based pharmacovigilance program involving the community pharmacists. Objectives: To collect the demographic details of the patients experiencing adverse drug reactions (ADR reported by the community pharmacists; to identify the common drugs causing the ADRs, the common types of ADRs; and to carry out the causality, severity and preventability assessments of the reported ADRs. Methods: The baseline Knowledge-Attitude-Practices (KAP of 116 community pharmacists from Pokhara valley towards drug safety was evaluated using a validated (Cronbach alpha=0.61 KAP questionnaire having 20 questions [(knowledge 11, attitude 5 and practice 4 maximum possible score 40]. Thirty community pharmacists with high scores were selected for three training sessions, each session lasting for one to two hours, covering the basic knowledge required for the community pharmacists for ADR reporting. Pharmacist from the regional pharmacovigilance center visited the trained community pharmacists every alternate day and collected the filled ADR reporting forms. Results: Altogether 71 ADRs, from 71 patients (37 males were reported. Antibiotics/ antibacterials caused 42% (n=37 of the total ADRs followed by non steroidal anti-inflammatory drugs [25% (n=22]. Ibuprofen/paracetamol combination accounted for ten ADRs. The most common type of ADR was itching [17.2 % (n=20, followed by generalized edema [8.6 % (n=10]. In order to manage the ADRs, the patients needed medical treatment in 69% (n=49 of the cases. Over two third (69% of the ADRs had a ‘possible’ association with the suspected drugs and a high percentage (70.4% were of ‘mild (level 2’ type. Nearly two third [64.7 % (n=46] of the ADRs were ‘definitely preventable’. Conclusion: The common class of drugs known to cause ADRs was antibacterial/ antibiotics. Ibuprofen

  11. SEVERE ADVERSE REACTIONS TO THE IODIC CONTRAST MEDIA AT THE UROGRAPHY

    Directory of Open Access Journals (Sweden)

    Rade R Babic

    2007-01-01

    Full Text Available During urography (IVU or any other kind of endographic examination, adverse reactions can develop during or immediately after intravascular application of iodine contrast media (ICM of which some endanger the patients’ health and life. The aim of the paper was to present adverse reactions of an organism to ICM. That is why the current interest in this problem has imposed to us a necessity to present this study.In the period from January 1994 to December 2005. in a Specialized Department of the Institute of Radiology of the Clinical Centre Nis, 11.885 IVU were done. An urographyc examination was performed with ionic or non ionic ICM of the same concentration (300 mg I/ml or an approximate to it, in the dosage of 1,0 ml/kg. Before intravenous application (iv, ICM was heated to body temperature. Application of ICM was done through the braunile, as a slow bolus, in the course of 1-1,5 min. In the series of 11.885 urographic examinations, there were severe adverse reactions in 17 patients (0,14% ili 1:699 IVU. There was no fatal outcome. Adverse reactions at our clinic that could have ended up with lethal outcome, with proper and prompt treatment ended with satisfactory results, so they were registered as severe reactions.

  12. Incidence of Adverse Reactions to Medicinal Products in Josina Machel Central Hospital during the Year of 2014

    Directory of Open Access Journals (Sweden)

    Mateus Sebastião João Fernandes

    2016-04-01

    Full Text Available Introduction: The lack of knowledge regarding the incidence of adverse drug reactions in the hospital setting and their impact on morbidity and mortality is, nowadays, a major health problem in Angola. In the last years, notifications of adverse drug reactions have been practically null, namely at a hospital level. It is of great importance to characterize the incidence of adverse drug reactions occurring in a hospital setting, in order to implement measures towards improving the quality of healthcare services. Material and Methods: We conducted a descriptive, prospective observational study to characterize the incidence of adverse drug reactions (ADRs in patients admitted to the Central Hospital “Josina Machel” in Luanda during the year 2014. An intensive monitoring through active search for adverse reactions possibly related with the drugs prescribed to patients was performed. Results: Of a total of 2041 hospitalized patients, 175 had adverse drug reactions. The incidence rate was 4.74% in the medicine service (n = 1077 and 12.86% in the therapy service (n = 964. A total of 209 adverse drug reactions were identified, averaging 1,2 adverse drug reactions per patient. The highest incidence rate of adverse drug reactions was recorded in patients aged between 18 and 35 years old, with 79 patients (45.14%. With regard to therapeutic class, it was found that antimicrobials were the drugs most commonly associated with adverse reactions, with 71 notifications (40.57%, followed by analgesics, antipyretics and anti-inflammatory steroids with 20,00%. Quinine and artesunate were the antimicrobials most frequently implicated in causing an adverse drug reaction, with 25 (14.29% and 15 (8.57% notifications respectively. In the group of anti-inflammatory drugs, diclofenac stood out with 13 notifications (7.43%. The most common clinical manifestations were skin rash, which corresponded to 23,44% of the total number of adverse drug reactions, followed by

  13. Prior adversities predict posttraumatic stress reactions in adolescents following the Oslo Terror events 2011.

    Science.gov (United States)

    Nordanger, Dag Ø; Breivik, Kyrre; Haugland, Bente Storm; Lehmann, Stine; Mæhle, Magne; Braarud, Hanne Cecilie; Hysing, Mari

    2014-01-01

    Former studies suggest that prior exposure to adverse experiences such as violence or sexual abuse increases vulnerability to posttraumatic stress reactions in victims of subsequent trauma. However, little is known about how such a history affects responses to terror in the general adolescent population. To explore the role of prior exposure to adverse experiences as risk factors for posttraumatic stress reactions to the Oslo Terror events. We used data from 10,220 high school students in a large cross-sectional survey of adolescents in Norway that took place seven months after the Oslo Terror events. Prior exposure assessed was: direct exposure to violence, witnessing of violence, and unwanted sexual acts. We explored how these prior adversities interact with well-established risk factors such as proximity to the events, perceived life threat during the terror events, and gender. All types of prior exposure as well as the other risk factors were associated with terror-related posttraumatic stress reactions. The effects of prior adversities were, although small, independent of adolescents' proximity to the terror events. Among prior adversities, only the effect of direct exposure to violence was moderated by perceived life threat. Exposure to prior adversities increased the risk of posttraumatic stress reactions equally for both genders, but proximity to the terror events and perceived life threat increased the risk more in females. Terror events can have a more destabilizing impact on victims of prior adversities, independent of their level of exposure. The findings may be relevant to mental health workers and others providing post-trauma health care.

  14. Prior adversities predict posttraumatic stress reactions in adolescents following the Oslo Terror events 2011

    Directory of Open Access Journals (Sweden)

    Dag Ø. Nordanger

    2014-05-01

    Full Text Available Background: Former studies suggest that prior exposure to adverse experiences such as violence or sexual abuse increases vulnerability to posttraumatic stress reactions in victims of subsequent trauma. However, little is known about how such a history affects responses to terror in the general adolescent population. Objective: To explore the role of prior exposure to adverse experiences as risk factors for posttraumatic stress reactions to the Oslo Terror events. Method: We used data from 10,220 high school students in a large cross-sectional survey of adolescents in Norway that took place seven months after the Oslo Terror events. Prior exposure assessed was: direct exposure to violence, witnessing of violence, and unwanted sexual acts. We explored how these prior adversities interact with well-established risk factors such as proximity to the events, perceived life threat during the terror events, and gender. Results: All types of prior exposure as well as the other risk factors were associated with terror-related posttraumatic stress reactions. The effects of prior adversities were, although small, independent of adolescents’ proximity to the terror events. Among prior adversities, only the effect of direct exposure to violence was moderated by perceived life threat. Exposure to prior adversities increased the risk of posttraumatic stress reactions equally for both genders, but proximity to the terror events and perceived life threat increased the risk more in females. Conclusions: Terror events can have a more destabilizing impact on victims of prior adversities, independent of their level of exposure. The findings may be relevant to mental health workers and others providing post-trauma health care.

  15. A serious adverse surgical event: Management of suspected HSV-1 keratitis in a donor cornea.

    Science.gov (United States)

    Kaye, Rebecca; Steger, Bernhard; Chen, Jern Y; Romano, Vito

    2017-01-01

    To describe the management of a serious adverse event in a patient undergoing penetrating keratoplasty (PK). A 68-year-old man underwent PK for an aphakic bullous keratopathy following previous complicated cataract surgery. He had no past history of herpetic disease. Storage of the corneoscleral disc in the transport bottle precluded microscopic examination. After placement of the trephined donor cornea on the open eye of the recipient, a large dendritiform geographic ulcer was noted on the donor cornea. A replacement cornea was used after changing potentially contaminated instruments. Intravenous antiviral treatment was commenced intraoperatively to reduce the risk of infection to the central nervous system. Postoperatively, oral and topical antiviral treatment was commenced and 6 months following surgery the patient developed a geographic corneal ulcer at the graft host interface. Containers to transport corneoscleral discs should enable microscopic examination by the surgeon prior to use. High dose systemic antivirals may reduce the risk of herpetic disease involving the posterior segment of the eye and neuroretina in the aphakic eye and spread to the central nervous system.

  16. INCIDENCE OF ADVERSE REACTIONS TO COMMONLY PRESCRIBED PSYCHOPHARMACOLOGICAL AGENTS DURING EARLY PHASE OF THERAPY

    OpenAIRE

    Kuruvilla, A.; Kuruvilla, K.

    1995-01-01

    Five hundred and ninety two patients attending a psychiatric department as outpatients or as inpatient were included in this study. Details regarding age, sex, diagnosis and drugs prescribed were entered in a proforma. The information regarding drugs prescribed, dosage and the types of reactions were noted. All patients were followed up for a period of 3 to 4 weeks. Incidence of adverse reactions was calculated as percentage of the total number of prescriptions of the same group of drugs. The...

  17. Inflammatory, immune-mediated adverse reactions related to soft tissue dermal fillers.

    Science.gov (United States)

    Alijotas-Reig, Jaume; Fernández-Figueras, Maria Teresa; Puig, Lluís

    2013-10-01

    An increasing number of persons seek medical solutions for esthetic indications and for diverse pathological conditions, such as malformations, trauma, or cancer. Despite manufacturers' and different authors' claims that fillers are non-immunogenic or that complications are uncommon, unwanted adverse reactions do occur. To review the literature regarding the multiple types of immune-mediated adverse reactions related to medical dermal filler injections/prosthesis. A comprehensive MEDLINE, PubMed, and Google Scholar electronic database search was performed (2000-January 2012). Selected articles published before 2000 referring to general concerns regarding the studied topic were also included. The search provided almost 300 articles. Finally, 235 studies were selected and included. All known fillers present in the market have been shown to be able to provoke early- and late-onset inflammatory adverse reactions. Their true prevalence is unknown but appears to be significant. The majority of the late-onset adverse effects are inflammatory and immune-mediated in nature. Edema, granulomas, sarcoid-like disorders, and panniculitis are the findings most commonly seen. Rarely, systemic granulomatous and autoimmune diseases, and to lesser extent acute hypersensitivity reactions can be seen. All implanted, injected, and blood-contact biomaterials trigger a wide variety of adverse reactions that may appear early or late and range from local to systemic. Most fillers act more as adjuvants than as direct T-cell activators, on a background of genetic predisposition. Their treatment has not been the subject of well-designed studies. Management of both acute and systemic reactions is often difficult and requires anti-inflammatory and occasionally immunosuppressive therapy. Copyright © 2013 Elsevier Inc. All rights reserved.

  18. Transfusion-related adverse reactions: From institutional hemovigilance effort to National Hemovigilance program.

    Science.gov (United States)

    Vasudev, Rahul; Sawhney, Vijay; Dogra, Mitu; Raina, Tilak Raj

    2016-01-01

    In this study we have evaluated the various adverse reactions related to transfusion occurring in our institution as a pilot institutional effort toward a hemovigilance program. This study will also help in understanding the problems faced by blood banks/Transfusion Medicine departments in implementing an effective hemovigilance program. All the adverse reactions related to transfusion of whole blood and its components in various clinical specialties were studied for a period of 1 year. Any transfusion-related adverse event was worked up in accordance with guidelines laid down by the Directorate General of Health Services (DGHS) and departmental standard operating procedures. During the study period from November 1, 2011 to October 31, 2012, 45812 components were issued [30939 WB/PRBC; 12704 fresh frozen plasma (FFP); 2169 platelets]. Risk estimation per 1000 units of red cells (WB/PRBC) transfused was estimated to be: 0.8 for febrile nonhemolytic transfusion reaction (FNHTR), 0.7 for allergic reaction, 0.19 for acute hemolytic transfusion reaction (AcHTR), 0.002 for anaphylactoid reactions, 0.1 for bacterial sepsis, and 0.06 for hypervolemia and hypocalcemia. 0.09 is the risk for delayed transfusion reaction and 0.03 is the risk for transfusion-related acute lung injury (TRALI). Risk estimate per 1,000 units of platelets transfused was estimated to be 1.38 for FNHTR, 1.18 for allergic reaction, and 1 in case of bacterial sepsis. Risk estimation per 1,000 units of FFP was estimated to be 0.15 for FNHTR and 0.2 for allergic reactions. Factors such as clerical checks at various levels, improvement in blood storage conditions outside blood banks, leukodepletion, better inventory management, careful donor screening, bedside monitoring of transfusion, and documentation of adverse events may decrease transfusion-related adverse events. Better coordination between transfusion specialists and various clinical specialties is the need of the hour and it will help in making

  19. Transfusion-related adverse reactions: From institutional hemovigilance effort to National Hemovigilance program

    Directory of Open Access Journals (Sweden)

    Rahul Vasudev

    2016-01-01

    Full Text Available Aims: In this study we have evaluated the various adverse reactions related to transfusion occurring in our institution as a pilot institutional effort toward a hemovigilance program. This study will also help in understanding the problems faced by blood banks/Transfusion Medicine departments in implementing an effective hemovigilance program. Materials and Methods: All the adverse reactions related to transfusion of whole blood and its components in various clinical specialties were studied for a period of 1 year. Any transfusion-related adverse event was worked up in accordance with guidelines laid down by the Directorate General of Health Services (DGHS and departmental standard operating procedures. Results: During the study period from November 1, 2011 to October 31, 2012, 45812 components were issued [30939 WB/PRBC; 12704 fresh frozen plasma (FFP; 2169 platelets]. Risk estimation per 1000 units of red cells (WB/PRBC transfused was estimated to be: 0.8 for febrile nonhemolytic transfusion reaction (FNHTR, 0.7 for allergic reaction, 0.19 for acute hemolytic transfusion reaction (AcHTR, 0.002 for anaphylactoid reactions, 0.1 for bacterial sepsis, and 0.06 for hypervolemia and hypocalcemia. 0.09 is the risk for delayed transfusion reaction and 0.03 is the risk for transfusion-related acute lung injury (TRALI. Risk estimate per 1,000 units of platelets transfused was estimated to be 1.38 for FNHTR, 1.18 for allergic reaction, and 1 in case of bacterial sepsis. Risk estimation per 1,000 units of FFP was estimated to be 0.15 for FNHTR and 0.2 for allergic reactions. Conclusions: Factors such as clerical checks at various levels, improvement in blood storage conditions outside blood banks, leukodepletion, better inventory management, careful donor screening, bedside monitoring of transfusion, and documentation of adverse events may decrease transfusion-related adverse events. Better coordination between transfusion specialists and various clinical

  20. Food avoidance in children with adverse food reactions: Influence of anxiety and clinical parameters

    NARCIS (Netherlands)

    Le, T.M.; Zijlstra, W.T.; Opstal, E.Y. van; Knol, M.J.; L'Hoir, M.P.; Knulst, A.C.; Pasmans, S.G.M.A.

    2013-01-01

    Background: Many children in the general population avoid food because of self-reported adverse food reactions (AFR). Food avoidance can have negative consequences for well-being and nutritional status. This study aimed to investigate which factors are related to avoidance behavior in children

  1. Adverse drug reactions in older patients during hospitalisation: are they predictable?

    LENUS (Irish Health Repository)

    O'Connor, Marie N

    2012-11-01

    adverse drug reactions (ADRs) are a major cause of morbidity and healthcare utilisation in older people. The GerontoNet ADR risk score aims to identify older people at risk of ADRs during hospitalisation. We aimed to assess the clinical applicability of this score and identify other variables that predict ADRs in hospitalised older people.

  2. Analysis of spontaneous reports of thromboembolic adverse drug reactions associated with cyproterone/ethinylestradiol

    NARCIS (Netherlands)

    Van Hunsel, F.; Van Puijenbroek, E.

    Introduction: After media attention on thromboembolic adverse drug reactions (ADRs) and the use of cyproterone/ethinylestradiol [1], the Netherlands Pharmacovigilance Centre Lareb received a high number of reports about this association, which called for a more detailed analyses. Aim: To provide an

  3. Pharmacogenetics of drug-induced arrhythmias : a feasibility study using spontaneous adverse drug reactions reporting data

    NARCIS (Netherlands)

    De Bruin, Marie L; van Puijenbroek, Eugene P; Bracke, Madelon; Hoes, Arno W; Leufkens, Hubert G M

    PURPOSE: The bottleneck in pharmacogenetic research on rare adverse drug reactions (ADR) is retrieval of patients. Spontaneous reports of ADRs may form a useful source of patients. We investigated the feasibility of a pharmacogenetic study, in which cases were selected from the database of a

  4. Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2013-01-01

    Reporting of adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals. In the European Union, more countries have allowed consumers to report ADRs directly to the regulatory agencies. The aim of this study was to characterize ADRs reported by European con...... consumer for nervous system medications....

  5. Variation in GNB3 predicts response and adverse reactions to antidepressants

    DEFF Research Database (Denmark)

    Keers, Robert; Bonvicini, Cristian; Scassellati, Catia

    2011-01-01

    There is substantial inter-individual variation in response and adverse reactions to antidepressants, and genetic variation may, in part, explain these differences. GNB3 encodes the β3 subunit of the G protein complex, which is involved in the downstream signalling cascade following monoamine...

  6. Adverse drug reactions and polypharmacy in the elderly in general practice

    NARCIS (Netherlands)

    Veehof, LJG; Stewart, RE; Meyboom-de Jong, B; Haaijer-Ruskamp, FM

    Objectives: The risk of adverse drug reactions (ADRs) increases with the number of drugs used. Most studies refer to potential interactions; the results regarding the severity of occurring and registered ADRs are inconsistent. Therefore, we examined the relevance of drug-induced problems in the

  7. Vitamin D deficiency as adverse drug reaction? A cross-sectional study in Dutch geriatric outpatients

    NARCIS (Netherlands)

    Orten-Luiten, van A.C.B.; Janse, A.; Dhonukshe-Rutten, R.A.M.; Witkamp, R.F.

    2016-01-01

    Purpose: Adverse drug reactions as well as vitamin D deficiency are issues of public health concern in older people. However, relatively little is known about the impact of drug use on vitamin D status. Our primary aim is to explore associations between drug use and vitamin D status in older

  8. Adverse drug reactions in children reported by European consumers from 2007 to 2011

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2014-01-01

    Background Information about medicines safety in children is very limited. Consumer adverse drug reaction (ADR) reports can provide information about serious and unknown ADRs from medicine use in children. Objective To characterize ADRs in children reported by consumers in Europe from 2007 to 2011...

  9. Dipeptidyl peptidase-4 inhibitor induced angioedema - an overlooked and potentially lethal adverse drug reaction?

    DEFF Research Database (Denmark)

    Scott, Susanne Irene; Andersen, Michelle Fog; Aagaard, Lise

    2018-01-01

    Introduction Angioedema is a potentially fatal adverse drug reaction of some medications, as swellings of the upper airways can cause death by asphyxiation. Angiotensin converting enzyme-inhibitors are widely known to cause angioedema but less is known about the association between dipeptidyl...

  10. Adverse Drug Reactions and Expected Effects to Therapy with Subcutaneous Mistletoe Extracts (Viscum album L.) in Cancer Patients.

    Science.gov (United States)

    Steele, Megan L; Axtner, Jan; Happe, Antje; Kröz, Matthias; Matthes, Harald; Schad, Friedemann

    2014-01-01

    Background. In Europe, mistletoe extracts are widely used as a complementary cancer therapy. We assessed the safety of subcutaneous mistletoe as a conjunctive therapy in cancer patients within an anthroposophic medicine setting in Germany. Methods. A multicentre, observational study was performed within the Network Oncology. Suspected mistletoe adverse drug reactions (ADRs) were described by frequency, causality, severity, and seriousness. Potential risk factors, dose relationships and drug-drug interactions were investigated. Results. Of 1923 cancer patients treated with subcutaneous mistletoe extracts, 283 patients (14.7%) reported 427 expected effects (local reactions <5 cm and increased body temperature <38°C). ADRs were documented in 162 (8.4%) patients who reported a total of 264 events. ADRs were mild (50.8%), moderate (45.1%), or severe (4.2%). All were nonserious. Logistic regression analysis revealed that expected effects were more common in females, while immunoreactivity decreased with increasing age and tumour stage. No risk factors were identified for ADRs. ADR frequency increased as mistletoe dose increased, while fewer ADRs occurred during mistletoe therapy received concurrent with conventional therapies. Conclusion. The results of this study indicate that mistletoe therapy is safe. ADRs were mostly mild to moderate in intensity and appear to be dose-related and explained by the immune-stimulating, pharmacological activity of mistletoe.

  11. Adverse Drug Reactions and Expected Effects to Therapy with Subcutaneous Mistletoe Extracts (Viscum album L. in Cancer Patients

    Directory of Open Access Journals (Sweden)

    Megan L. Steele

    2014-01-01

    Full Text Available Background. In Europe, mistletoe extracts are widely used as a complementary cancer therapy. We assessed the safety of subcutaneous mistletoe as a conjunctive therapy in cancer patients within an anthroposophic medicine setting in Germany. Methods. A multicentre, observational study was performed within the Network Oncology. Suspected mistletoe adverse drug reactions (ADRs were described by frequency, causality, severity, and seriousness. Potential risk factors, dose relationships and drug-drug interactions were investigated. Results. Of 1923 cancer patients treated with subcutaneous mistletoe extracts, 283 patients (14.7% reported 427 expected effects (local reactions <5 cm and increased body temperature <38°C. ADRs were documented in 162 (8.4% patients who reported a total of 264 events. ADRs were mild (50.8%, moderate (45.1%, or severe (4.2%. All were nonserious. Logistic regression analysis revealed that expected effects were more common in females, while immunoreactivity decreased with increasing age and tumour stage. No risk factors were identified for ADRs. ADR frequency increased as mistletoe dose increased, while fewer ADRs occurred during mistletoe therapy received concurrent with conventional therapies. Conclusion. The results of this study indicate that mistletoe therapy is safe. ADRs were mostly mild to moderate in intensity and appear to be dose-related and explained by the immune-stimulating, pharmacological activity of mistletoe.

  12. CYP2C9 polymorphism in patients with epilepsy: genotypic frequency analyzes andphenytoin adverse reactions correlation

    Directory of Open Access Journals (Sweden)

    Carlos Alexandre Twardowschy

    2011-04-01

    Full Text Available OBJECTIVE: CYP2C9 is a major enzyme in human drug metabolism and the polymorphism observed in the corresponding gene may affect therapeutic outcome during treatment. The distribution of variant CYP2C9 alleles and prevalence of phenytoin adverse reactions were hereby investigated in a population of patients diagnosed with epilepsy. METHOD: Allele-specific PCR analysis was carried out in order to determine frequencies of the two most common variant alleles, CYP2C9*2 and CYP2C9*3 in genomic DNA isolated from 100 epileptic patients. We also analyzed the frequency of phenytoin adverse reactions among those different genotypes groups. The data was presented as mean±standard deviation. RESULTS: The mean age at enrollment was 39.6±10.3 years (range, 17-72 years and duration of epilepsy was 26.5±11.9 years (range 3-48 years. The mean age at epilepsy onset was 13.1±12.4 years (range, 1 month-62 years. Frequencies of CYP2C9*1 (84%, CYP2C9*2 (9% and CYP2C9*3 (7% were similar to other published reports. Phenytoin adverse reactions were usually mild and occurred in 15% patients, without correlation with the CYP2C9 polymorphism (p=0.34. CONCLUSION: Our findings indicate an overall similar distribution of the CYP2C9 alleles in a population of patients diagnosed with epilepsy in the South of Brazil, compared to other samples. This sample of phenytoin users showed no drug related adverse reactions and CYP2C9 allele type correlation. The role of CYP2C9 polymorphism influence on phenytoin adverse reaction remains to be determined since some literature evidence and our data found negative results.

  13. Increased adverse drug reactions to cephalosporins in penicillin allergy patients with positive penicillin skin test.

    Science.gov (United States)

    Park, Miguel A; Koch, Cody A; Klemawesch, Patrick; Joshi, Avni; Li, James T

    2010-01-01

    Cephalosporin administration in patients with a history of penicillin allergy is controversial. Studies looking at the safety of cephalosporin in patients with a history of penicillin allergy lacked a control group, had a small number of patients, and/or lacked confirmation of penicillin allergy by penicillin skin testing. The purpose of this study was to determine whether patients with penicillin allergy were at increased risk of adverse drug reactions when administered cephalosporin. A cohort study of patients with a history of penicillin allergy and a positive or negative penicillin skin test when administered cephalosporin was conducted. Charts were reviewed for adverse drug reactions to cephalosporin after penicillin skin testing. Eighty-five patients with a history of penicillin allergy and positive penicillin skin test and 726 patients with a history of penicillin allergy and negative penicillin skin test were administered cephalosporin. Five (6%) of 85 cases had an adverse drug reaction to cephalosporin as compared to 5 (0.7%) of 726 of the referent population (p = 0.0019). The rate of presumed IgE-mediated adverse drug reactions to the cephalosporins amongst the cases was 2 (2%) of 85 compared to 1 (0.1%) of 726 amongst the referent population (p = 0.0304). A greater risk of an adverse drug reaction to cephalosporin exists in patients with penicillin allergy. We recommend penicillin skin testing if cephalosporin, especially a first-generation cephalosporin, is to be administered to patients with a history of penicillin allergy. Copyright © 2010 S. Karger AG, Basel.

  14. Anti-snake venom: use and adverse reaction in a snake bite study clinic in Bangladesh

    Directory of Open Access Journals (Sweden)

    MR Amin

    2008-01-01

    Full Text Available Snakebites can present local or systemic envenomation, while neurotoxicity and respiratory paralysis are the main cause of death. The mainstay of management is anti-snake venom (ASV, which is highly effective, but liable to cause severe adverse reactions including anaphylaxis. The types of adverse reaction to polyvalent anti-snake venom have not been previously studied in Bangladesh. In this prospective observational study carried out between 1999 and 2001, in the Snake Bite Study Clinic of Chittagong Medical College Hospital, 35 neurotoxic-snake-bite patients who had received polyvalent anti-snake venom were included while the ones sensitized to different antitoxins and suffering from atopy were excluded. The common neurotoxic features were ptosis (100%, external ophthalmoplegia (94.2%, dysphagia (77.1%, dysphonia (68.5% and broken neck sign (80%. The percentage of anti-snake venom reaction cases was 88.57%; pyrogenic reaction was 80.64%; and anaphylaxis was 64.51%. The common features of anaphylaxis were urticaria (80%; vomiting and wheezing (40%; and angioedema (10%. The anti-snake venom reaction was treated mainly with adrenaline for anaphylaxis and paracetamol suppository in pyrogenic reactions. The average recovery time was 4.5 hours. Due to the danger of reactions the anti-snake venom should not be withheld from a snakebite victim when indicated and appropriate guidelines should be followed for its administration.

  15. Adverse drug reactions to CT contrast media in south Korea: Incidence and risk factors

    Energy Technology Data Exchange (ETDEWEB)

    Bae, Kyung Soo; Jeon, Kyung Nyeo; Moon, Jin Il; Choi, Bo Hwa; Baek, Hye Jin; Cho, Soo Buem [Dept. of Radiology, Gyeongsang National University Changwon Hospital, Gyeongsang National University School of Medicine, Changwon (Korea, Republic of); Lee, Sang Min; Ha, Ji Young; Choi, Dae Seob; Cho, Jae Min; Na, Jae Beom [Dept. of Radiology, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju (Korea, Republic of)

    2016-07-15

    To evaluate the incidence, severity, and risk factors of adverse drug reactions (ADR) to intravenous administration of nonionic iodinated contrast media in computed tomography (CT), and to determine the recurrence rate after premedication in patients with a previous history of ADR. We prospectively recorded all ADR to intravenous CT contrast media in 32313 consecutive outpatients (54572 cases) who underwent contrast enhanced CT examinations. Clinical report forms and electronic medical records were reviewed to search for the incidence of ADR, treatment, and clinical outcome of patients. The risk factors of ADR to CT contrast media (age, sex, history of previous ADR, season) were evaluated using statistical analysis. Of the 54572 cases, a total of 191 (0.35%) had adverse reactions. Of the 191 cases, 157 (82%) were categorized as mild reactions, 29 (15%) were moderate, and 5 (3%) were severe. A total of 165 (86.4%) cases had acute adverse reactions (which occurred within 1 hour after administration), while 26 (13.6%) had delayed adverse reactions (occurred 1 hour after the administration). The rate of ADR was significantly higher in females [relative risk (RR) = 2.05, 95% confidence interval (CI) 1.53-2.75], patients under the age of 60 years (RR = 1.45, 95% CI 1.07-1.98), patients with a history of previous ADR (RR = 6.51, 95% CI 3.13-13.57), and in the spring season (RR = 1.44, 95% CI 1.07-1.95). The recurrence rate after premedication in patients with previous ADR to CT contrast media was 3.2% (8/247). No deaths occurred that were attributed to the contrast media. The incidence of ADR to nonionic CT contrast media was 0.35%; most of which were mild reactions. Risk factors for ADR included female gender, an age of under 60 years, a history of previous ADR, and spring season.

  16. Report on survey of the adverse reaction to radiopharmaceuticals, 12; The 15th survey in 1989

    Energy Technology Data Exchange (ETDEWEB)

    1991-04-01

    This is the 12th report concerning adverse reactions to radiopharmaceuticals occurring during the period from April 1, 1989 through March 31, 1990. Questionnaires were sent to 1,111 facilities, and 827 (74.4%) responded. Twenty two cases of adverse reactions and 10 cases of drug defect were reported from a total of 29 facilities (3.5%), giving an annual occurrence of 2.4 cases and 1.1 cases, respectively, for 100, 000 examinations. The incidence of adverse reactions was the highest for I-131-6B-iodomethyl-19-norcholesterol (184 cases/100,000 examinations), followed by I-131 sodium hippurate (22), Tc-99m HSA-DTPA (20), Tc-99m HM-PAO (13), Tc-99m pyrophosphate and Tc-99m DTPA (8), and Tl-201 thallium chloride and I-123 IMP (2). Adverse reactions included reactions to the vagus nerves (n=10), allergic reactions (n=6), and others (n=6); they were characterized by face or skin redness and nausea or vomiting induced by Tc-99m pyrophosphate, eruptions 5 hr after Tl-201 thallium chloride injection, and symptoms following the injection of Tc-99m HM-PAO, I-123 IMP, and Tc-99m HSA-DTPA. Radiopharmaceuticals reported as drug defects were as follows: Tc-99m MDP, Tc-99m tin colloid, Tl-201 thallium chloride, Tc-99m MAA, Tc-99m HMDP, Tc-99m HM-PAO, Xe-133 gas, and Tc-99m generator. (N.K.).

  17. Adverse reactions, psychological factors, and their effect on donor retention in men and women.

    Science.gov (United States)

    Veldhuizen, Ingrid; Atsma, Femke; van Dongen, Anne; de Kort, Wim

    2012-09-01

    This study investigates the effect of a vasovagal reaction (VVR) or needle reaction (NR) on the risk of stopping as a blood donor, taking into account variables from the Theory of Planned Behavior (TPB). Is stopping risk solely related to the adverse reaction itself, or do the TPB variables play a role as well? Emphasis is placed on possible sex differences. TPB variables were assessed within 12,051 whole blood donors. Also, donors reported the occurrence of adverse reactions during or after their last donation. Blood bank records were used to determine whether donors stopped donating within the next 2 years. Logistic regression analyses were performed to estimate the effect of self-reported adverse reactions on stopping risk, adjusting for the TPB variables. Analyses were performed separately for both sexes. Men have a lower odds of reporting a NR or a VVR than women (odds ratio [OR] 0.34, 95% confidence interval [CI], 0.28-0.43; and OR 0.26, 95% CI 0.19-0.36, for NR and VVR, respectively). For both sexes, only a VVR was associated with stopping risk, which is higher in men (men, OR 3.95, 95% CI 2.19-7.11; women, OR 1.78, 95% CI 1.35-2.35). After adjusting for the TPB variables both ORs declined (men, OR 3.38, 95% CI 1.86-6.15; women, OR 1.58, 95% CI 1.17-2.14). Also, self-efficacy and affective attitude are negatively associated with adverse reactions. Female donors report more VVRs than male donors, but male donors have a higher stopping risk after a VVR than female donors. Coping differences and possible reporting tendencies might play a role. For donor retention purposes, prevention and coping techniques should take sex differences into account. © 2012 American Association of Blood Banks.

  18. Cutaneous adverse reactions of imatinib therapy in patients with chronic myeloid leukemia: A six-year follow up.

    Science.gov (United States)

    Dervis, Emine; Ayer, Mesut; Akin Belli, Asli; Barut, Saime Gul

    2016-04-01

    Imatinib is a tyrosine kinase inhibitor used in the treatment of chronic myeloid leukemia (CML). Cutaneous adverse reactions of imatinib therapy have been reported in 7%-88.9% patients. We sought to evaluate the prevalence rates of cutaneous adverse reactions of imatinib therapy and to investigate the clinical and pathological characteristics of these reactions. Sixty-six patients (36 men, 30 women; age range 19-83 years) with CML treated with imatinib between 2008 and 2014 were included in the study. Clinical and pathological features of the adverse reactions were investigated. Cutaneous adverse reactions were the most common adverse effects of imatinib therapy and were seen in nine patients with a prevalence rate of 13.6%. The second most common adverse effect was musculoskeletal pain (12.1%). The following cutaneous reactions were observed in patients: edema, rash, pigmentary changes, aphthous stomatitis, alopecia, cutaneous dryness, hyperhidrosis and cheilitis. Imatinib therapy was discontinued in four patients because of various adverse effects. Although the prevalence rate of cutaneous adverse reactions in our study was lower than that in several other studies, cutaneous reactions were common in our study. The relatively low prevalence rate of adverse reactions may be related to the low dosage of imatinib (400 mg/day) used to treat our patients and may have been affected by pharmacogenetic characteristics of our population.

  19. Adverse reactions to blood donation: A descriptive study of 3520 blood donors in a Nigerian tertiary hospital

    National Research Council Canada - National Science Library

    C Aneke John; U Ezeh Theodora; A Nwosu Gloria; E Anumba Chika

    2017-01-01

    Background: The occurrence of adverse reactions to blood donation significantly hampers donor retention and negatively impacts on the universal availability of adequate numbers of blood donor units. Objective...

  20. Bypassing adverse injection reactions to nanoparticles through shape modification and attachment to erythrocytes

    Science.gov (United States)

    Wibroe, Peter Popp; Anselmo, Aaron C.; Nilsson, Per H.; Sarode, Apoorva; Gupta, Vivek; Urbanics, Rudolf; Szebeni, Janos; Hunter, Alan Christy; Mitragotri, Samir; Mollnes, Tom Eirik; Moghimi, Seyed Moein

    2017-07-01

    Intravenously injected nanopharmaceuticals, including PEGylated nanoparticles, induce adverse cardiopulmonary reactions in sensitive human subjects, and these reactions are highly reproducible in pigs. Although the underlying mechanisms are poorly understood, roles for both the complement system and reactive macrophages have been implicated. Here, we show the dominance and importance of robust pulmonary intravascular macrophage clearance of nanoparticles in mediating adverse cardiopulmonary distress in pigs irrespective of complement activation. Specifically, we show that delaying particle recognition by macrophages within the first few minutes of injection overcomes adverse reactions in pigs using two independent approaches. First, we changed the particle geometry from a spherical shape (which triggers cardiopulmonary distress) to either rod- or disk-shape morphology. Second, we physically adhered spheres to the surface of erythrocytes. These strategies, which are distinct from commonly leveraged stealth engineering approaches such as nanoparticle surface functionalization with poly(ethylene glycol) and/or immunological modulators, prevent robust macrophage recognition, resulting in the reduction or mitigation of adverse cardiopulmonary distress associated with nanopharmaceutical administration.

  1. Adverse cutaneous reactions to epidermal growth factor receptor inhibitors: a study of 14 patients.

    Science.gov (United States)

    Santiago, Felicidade; Gonçalo, Margarida; Reis, José Pedro; Figueiredo, Américo

    2011-01-01

    Cetuximab and erlotinib, epidermal growth factor receptor inhibitors, often cause peculiar adverse cutaneous reactions. Our aim was to evaluate adverse cutaneous reactions and their management in patients undergoing treatment with cetuximab and erlotinib. Between March/2005 and September/2009, we observed 14 patients with a mean age of 59.6 years undergoing treatment with cetuximab (7) or erlotinib (7), due to lung(10) or colorectal cancer (4). We evaluated the interval between introduction of the drug and onset of symptoms, treatment response, and the clinical pattern of evolution of the cutaneous reaction retrospectively. Twelve patients presented papular-pustular eruption typically affecting the face, chest and back, which appeared in average 13.5 days after starting the drug treatment. The patients underwent oral treatment with minocycline or doxycycline and topical treatment with metronidazole, benzoyl peroxide and/or corticosteroids. All patients showed improvement of the lesions. Five patients presented periungual pyogenic granulomas, which were associated with paronychia in 4 cases, after an average of 8 weeks of treatment. There was improvement of the lesions with topical treatment (antibiotics, corticosteroids and antiseptics). Xerosis was observed in some patients. Other less frequent adverse side effects such as telangiectasia and angiomas, hair and eyelash alterations, and eruptive melanocytic nevi were also described. Treatment with epidermal growth factor receptor inhibitor was maintained in most patients. The increasing use of these targeted therapies requires knowledge of their adverse cutaneous side effects to ensure timely intervention in order to allow the continuation of the therapy.

  2. Study of adverse drug reactions in out-patient departments of a teaching hospital

    Directory of Open Access Journals (Sweden)

    Zinnat Ara Begum

    2012-06-01

    Full Text Available The study conducted in the Medicine and Skin outpatient departments of Dhaka Medical College, Dhaka revealed 19 cases (7 males, 12 females of adverse drug reactions (ADR out of 160 patients. 31.58% ADRs were of mild type, 42.1% were of moderate and 26.32% were of severe in nature. Gastrointestinal complications were the most frequent adverse effect (56%. Antimicrobial drugs were the most common cause of ADR (42.86% followed by NSAIDs (33.33%. This study is a preliminary study for getting information on the pattern of ADRs in Bangladesh needing further studies.

  3. Bypassing adverse injection reactions to nanoparticles through shape modification and attachment to erythrocytes

    DEFF Research Database (Denmark)

    Wibroe, Peter Popp; Anselmo, Aaron C; Nilsson, Per H

    2017-01-01

    by macrophages within the first few minutes of injection overcomes adverse reactions in pigs using two independent approaches. First, we changed the particle geometry from a spherical shape (which triggers cardiopulmonary distress) to either rod- or disk-shape morphology. Second, we physically adhered spheres...... and reactive macrophages have been implicated. Here, we show the dominance and importance of robust pulmonary intravascular macrophage clearance of nanoparticles in mediating adverse cardiopulmonary distress in pigs irrespective of complement activation. Specifically, we show that delaying particle recognition...

  4. Hepatic adverse drug reactions: a case/non-case study in Italy.

    Science.gov (United States)

    Motola, Domenico; Vargiu, Antonio; Leone, Roberto; Cocci, Alfredo; Salvo, Francesco; Ros, Barbara; Meneghelli, Ilaria; Venegoni, Mauro; Cutroneo, Paola Maria; Vaccheri, Alberto; Velo, Gianpaolo; Montanaro, Nicola

    2007-01-01

    Adverse drug reactions (ADRs) can involve all tissues and organs. Liver injuries are considered among the most serious and are a cause for concern among physicians and patients. To assess the extent of drug-induced liver injuries in Italy we compared the number of cases of hepatic ADRs with reports of all other drug-related reactions present in the same database. Spontaneous reports from six Italian Regions collected from January 1990 to May 2005 were analysed. Adverse reactions were classified according to WHO Adverse Reaction Terminology for causality assessment, and only those with "certain", "probable" or "possible" causality assessment were included. Association between drugs and hepatic ADRs was assessed using the case/non case method, calculating the ADR reporting odds ratio (ROR) as a measure of disproportionality. On May 2005, the database contained 35,767 ADR reports, of which 11,829 were excluded because they were unclassifiable or unlikely in terms of causality assessment. Therefore, the analysis was carried out on 23,938 reports, of which 1,069 concerned hepatic ADRs (cases) and 22,869 concerned non-cases. The proportion of serious ADRs was about 40% in the overall database, and about 74% among cases. The drug classes with the highest number of cases were statins (ROR = 2.9, 95% CI 2.4-3.5), antiplatelet agents (ROR = 3.5; 95% CI 2.6-4.6), NSAIDs (ROR = 2.9; 95% CI 2.1-3.9) and macrolides (ROR = 1.7; 95% CI 1.2-2.3). Hepatic adverse drug reactions remain a serious concern for several drugs widely used in clinical practice. Monitoring hepatic enzymes on a monthly basis for the first 6 months of treatment has been suggested for patients taking medications known to be hepatotoxic. A better knowledge of the epidemiology and mechanisms of hepatic ADRs may contribute to minimising their occurrence.

  5. Adverse reactions following routine anticholinergic eye drops in a paediatric population: an observational cohort study

    Science.gov (United States)

    van Minderhout, Helena M; Joosse, Maurits V; Grootendorst, Diana C

    2015-01-01

    Objectives To investigate the presence, nature and relationship to age, sex, ethnicity and body mass index (BMI) of adverse reactions following routine cycloplegic eye drops in children. Design Prospective observational cohort study. Setting Ophthalmology outpatient clinic Dutch metropolitan hospital; February, March and April 2009. Participants Children aged 3–14-year-old children receiving two drops of cyclopentolate 1% (C+C) or one drop of cyclopentolate 1% and one drop of tropicamide 1% (C+T). Patients were categorised by age (3–6, 7–10 and 11–14 years), sex, ethnicity and body mass index (BMI) (low, normal or high). Outcome measures Rate and nature of adverse reactions reported at 45 min following treatment. Crude and adjusted ORs for reporting an adverse reaction using stepwise regression analysis with BMI, age, ethnicity and sex. Results 912 of 915 eligible patients participated (99.7%). Adverse reactions were reported for C+C in 10.3% and in C+T in 4.8% (42/408 and 24/504, p=0.002), respectively. Central effects were present in 95% in C+C and in 92% in C+T. Compared to C+T, an increased risk was present in C+C (crude OR 2.3 (1.4 to 3.9), p=0.002). Forward adjustment showed BMI to be an influencing factor in treatment (OR 3.1 (1.7 to 5.6), p<0.001). In a multivariate model, a dose of cyclopentolate remained associated with adverse reactions. Analysis per BMI and regime and age category and regime, indicated associations with low BMI (OR C+C 21.4 (6.7 to 67.96), p<0.001, respectively, C+T 5.2 (2.1 to 12.8), p<0.001) and young age (OR C+C 8.1 (2.7 to 24.8), p<0.001). Conclusions Adverse reactions were common and almost exclusively involved the central nervous system. Both presence and severity were associated with repeated instillation of cyclopentolate 1%, low BMI and young age. In specific paediatric populations, a single dose of cyclopentolate must be considered. Vital function monitoring facilities are advisable. Adjustment of guidelines is

  6. Changes in risk of immediate adverse reactions to iodinated contrast media by repeated administrations in patients with hepatocellular carcinoma.

    Science.gov (United States)

    Fujiwara, Naoto; Tateishi, Ryosuke; Akahane, Masaaki; Taguri, Masataka; Minami, Tatsuya; Mikami, Shintaro; Sato, Masaya; Uchino, Koji; Uchino, Kouji; Enooku, Kenichiro; Kondo, Yuji; Asaoka, Yoshinari; Yamashiki, Noriyo; Goto, Tadashi; Shiina, Shuichiro; Yoshida, Haruhiko; Ohtomo, Kuni; Koike, Kazuhiko

    2013-01-01

    To elucidate whether repeated exposures to iodinated contrast media increase the risk of adverse reaction. We retrospectively reviewed 1,861 patients with hepatocellular carcinoma who visited authors' institution, a tertiary referral center, between 2004 and 2008. We analyzed cumulative probability of adverse reactions and risk factors. We categorized all symptoms into hypersensitivity reactions, physiologic reactions, and other reactions, according to the American College of Radiology guidelines, and evaluated each category as an event. We estimated the association between hazard for adverse reactions and the number of cumulative exposures to contrast media. We also evaluated subsequent contrast media injections and adverse reactions. There were 23,684 contrast media injections in 1,729 patients. One hundred and thirty-two patients were excluded because they were given no contrast media during the study period. Adverse reactions occurred in 196 (0.83%) patients. The cumulative incidence at 10(th), 20(th), and 30(th) examination was 7.9%, 15.2%, and 24.1%, respectively. Presence of renal impairment was found to be one of risk factors for adverse reactions. The estimated hazard of overall adverse reaction gradually decreased until around 10(th) exposure and rose with subsequent exposures. The estimated hazard of hypersensitivity showed V-shaped change with cumulative number of exposures. The estimated hazard of physiologic reaction had a tendency toward decreasing and that of other reaction had a tendency toward increasing. Second adverse reaction was more severe than the initial in only one among 130 patients receiving subsequent injections. Repeated exposures to iodinated contrast media increase the risk of adverse reaction.

  7. Adverse reactions and tolerability of high-dose sublingual allergen immunotherapy

    Directory of Open Access Journals (Sweden)

    Moral A

    2016-06-01

    Full Text Available Angel Moral,1 Victoria Moreno,2 Francisco Girón,3 David El-Qutob,4 José D Moure,5 Manuel Alcántara,6 Antonia Padial,7 Alberto G Oehling,8 Carmen Millán,9 Fernando de la Torre10 1Allergy Service, Hospital Virgen del Valle, Toledo, 2Allergy Service, Hospital Blanca Paloma, Huelva, 3Consulta Privada, Granada, 4Allergy Service, Clínica Atenea, Castellón, 5Pediatric Department, Complejo Hospitalario Universitario de Santiago, A Coruña, 6Allergy Service, Complejo Hospitalario de Jaén, Jaén, 7Allergy Service, Hospital Infanta Sofía, Madrid, 8Centro de Alergia y Asma Balear, Mallorca, 9Consulta Privada, Cádiz, 10ALK-Abelló, SA, Madrid, Spain Background: Sublingual allergen immunotherapy is an effective treatment against allergic respiratory disease. Many studies have shown the safety of this type of therapy, although the factors that might affect the tolerability of high-dose sublingual immunotherapy have not been well established. The aim of this study was to determine the factors that affect the tolerability of sublingual allergen immunotherapy.Patients and methods: A total of 183 subjects aged ≥5 years, diagnosed with allergic rhinitis with/without mild to moderate asthma due to sensitization to grass, olive pollen, or mites, were included in this open, retrospective, multicentric, noninterventional study. Sublingual immunotherapy was administered for at least 3 months.Results: The most frequent adverse reaction was oral pruritus (13.7% of the patients. Most of the reactions were local (84.7% and immediate (93.5% and occurred during the initiation phase (60.6%. All reactions were mild to moderate in severity. No serious adverse reactions were registered. When comparing factors with potential influence on the occurrence of adverse reactions, the results between the groups of subjects with and without adverse reactions showed no statistically significant differences in sex (P=0.6417, age (P=0.1801, years since the disease was first

  8. The concept of adverse drug reaction reporting: awareness among pharmacy students in a Nigerian university

    Directory of Open Access Journals (Sweden)

    Johnson Segun Showande

    2013-01-01

    Full Text Available Adverse drug reaction (ADR is poorly reported globally but more in developing countries with poor participation by health professionals. Currently, there is no known literature on the Nigerian pharmacy students’ knowledge on ADR reporting. Hence the purpose of this study was to find out the level of knowledge of pharmacy students on the concept of pharmacovigilance and adverse drug reaction reporting and also to evaluate their opinions on the National Pharmacovigilance Centre guidelines on adverse drug reaction reporting. A pretested 34-item semi-structured questionnaire was administered among 69 pharmacy undergraduate students in their penultimate and final years that consented to take part in the study, in one of the universities in Nigeria. The study was carried out strictly adhering to the principles outlined in the Helsinki declaration of 1964, which was revised in 1975. The questionnaire used had four sections which included a section on biographical data, a section which evaluated the students knowledge on the concept of pharmacovigilance and adverse drug reaction reporting, a section on students personal experiences of adverse drug reactions and modes of reporting them and the final section of the questionnaire evaluated the students’ opinions on the National Pharmacovigilance Centre guidelines for reporting adverse drug reactions. Descriptive statistics, Mann-Whitney U and Kruskal Wallis statistical tests were used to analyze the data obtained. None of the participants knew the sequence of reporting ADR. More than half, 40(58.0% had heard about pharmacovigilance at symposiums, 7(10.1% during clinical clerkship program and 18(26.1% from media jingles. Twenty nine (42.0% agreed that pharmacovigilance was in their curriculum, however only 16(23.2% could define the term correctly. None of the participants had seen or used an ADR form prior to the study, but the students could easily identify and describe the type of ADR they had

  9. Adverse reaction after hyaluronan injection for minimally invasive papilla volume augmentation

    DEFF Research Database (Denmark)

    Bertl, Kristina; Gotfredsen, Klaus; Jensen, Simon S

    2017-01-01

    tenderness with a burning sensation on the lip next to the injection area, after the second injection session. In one of the cases, a net-like skin discoloration (livedo reticularis) was also noted. The symptoms lasted for up to 7 days, and in both cases, symptoms resolved without any signs of skin......OBJECTIVES: To report two cases of adverse reaction after mucosal hyaluronan (HY) injection around implant-supported crowns, with the aim to augment the missing interdental papilla. MATERIAL AND METHODS: Two patients with single, non-neighbouring, implants in the anterior maxilla, who were treated...... within the frames of a randomized controlled clinical trial testing the effectiveness of HY gel injection to reconstruct missing papilla volume at single implants, presented an adverse reaction. Injection of HY was performed bilaterally using a 3-step technique: (i) creation of a reservoir in the mucosa...

  10. [Recomendations for the prevention of adverse drug reactions in older adults with dementia].

    Science.gov (United States)

    Gómez-Pavón, Javier; González García, Paloma; Francés Román, Inés; Vidán Astiz, Maite; Gutiérrez Rodríguez, José; Jiménez Díaz, Gregorio; Montero Fernández, Nuria Pilar; Alvarez Fernández, Baldomero; Jiménez Páez, José María

    2010-01-01

    The elderly are one of the groups at greatest risk for adverse drugs reactions (ADR). The mean prevalence of these reactions in this population is 30%. Dementia is not an independent risk factor of ADR, but is the main condition that increases all risk factors (polypharmacy, comorbidity, inappropriate prescribing, drug-drug interactions, advanced age, and treatment adherence). The present article discusses revised and consensual recommendations for the prevention of ADR in the elderly, as well as recommendations specifically for dementia patients in relation to the management of comorbidity and cognitive, behavioral and psychological symptoms. Copyright 2009 SEGG. Published by Elsevier Espana. All rights reserved.

  11. Recent advances of pharmacogenomics in severe cutaneous adverse reactions: immune and nonimmune mechanisms

    Science.gov (United States)

    Dao, Ro-Lan; Su, Shih-Chi

    2015-01-01

    Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) are severe cutaneous adverse reactions (SCAR) which are majorly caused by drugs. Though the incidence rate is low, SCAR sometimes can be life-threatening and leads to lifelong sequelae. Many pharmacogenomic associations in immune and nonimmune related genes with the development of SCAR have been discovered recently and the pharmacogenetic tests have been applied to prevent specific drug-induced SCAR. In this review, we discuss the recent advances of pharmacogenomics in SCAR. PMID:25938070

  12. Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria

    OpenAIRE

    Oshikoya, Kazeem A; Awobusuyi, Jacob O

    2009-01-01

    Background Spontaneous adverse drug reaction (ADR) reporting is the cornerstone of pharmacovigilance. ADR reporting with Yellow Cards has tremendously improved pharmacovigilance of drugs in many developed countries and its use is advocated by the World Health Organization (WHO). This study was aimed at investigating the knowledge and attitude of doctors in a teaching hospital in Lagos, Nigeria on spontaneous ADR reporting and to suggest possible ways of improving this method of reporting. Met...

  13. Adverse Reactions to Foods and Food Allergy: Development and Reproducibility of a Questionnaire for Clinical Diagnosis

    OpenAIRE

    Lyra, Nilza R. S.; Motta, Maria E.F.A.; Luiz A. R. Rocha; Dirceu Solé; Peixoto, Décio M.; Rizzo, José A.; Luis Taborda-Barata; Sarinho, Emanuel S.C.

    2013-01-01

    Objective. To develop a questionnaire as a screening tool for adverse reactions to foods in children and to assess the technical reproducibility by test-retest. Methods. Reproducibility of the questionnaire was performed by the literature review, preparing the preliminary questionnaire, peer review, pretest, and retest analysis. The study of the test-retest reproducibility was cross-sectional and descriptive. Kappa coefficient was used to study the reproducibility of the questionnaire. The sa...

  14. Delayed adverse reactions to the parenteral administration of iodinated contrast media.

    Science.gov (United States)

    Egbert, Robert E; De Cecco, Carlo N; Schoepf, U Joseph; McQuiston, Andrew D; Meinel, Felix G; Katzberg, Richard W

    2014-12-01

    This article presents an overview of delayed adverse reactions (DARs) to parenteral iodinated contrast media and discusses the clinical nature, risk factors, mechanisms, and potential economic implications of these DARs. DARs to contrast media are not rare but are often not recognized as being linked to contrast administration and may be falsely ascribed to other drugs. These side effects are problematic because the patient is usually without medical supervision.

  15. Adverse drug reactions and drug?drug interactions with over-the-counter NSAIDs

    OpenAIRE

    Moore, Nicholas; Pollack, Charles; Butkerait, Paul

    2015-01-01

    Nicholas Moore,1 Charles Pollack,2 Paul Butkerait2 1Department of Pharmacology, Université de Bordeaux, Bordeaux, France; 2Pfizer Consumer Healthcare, Madison, NJ, USA Abstract: Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen have a long history of safe and effective use as both prescription and over-the-counter (OTC) analgesics/antipyretics. The mechanism of action of all NSAIDs is through reversible inhibition of cyclooxygenase enzymes. Adverse drug reactions (A...

  16. Knowledge, Attitude and Practice of Adverse Drug Reactions Reporting Among Healthcare Professionals

    OpenAIRE

    Siddeshwara M.G.; Jeevangi Santoshkumar; Vardhamane S. H.

    2016-01-01

    Objectives:  This study was conducted to evaluate knowledge, attitude and practice of Adverse Drug Reactions (ADR) reporting among Healthcare Professionals.Methods: A cross-sectional study was done by survey using questionnaire. Questionnaire was distributed to 260 healthcare professionals working at M.R. Medical College and S Nijalingappa Institute of Dental Sciences, Kalaburagi, India.Results: Out 260 people 221 provided the response, giving a response rate of 85%. Among respondents 69.68% ...

  17. Nifurtimox therapy for Chagas disease does not cause hypersensitivity reactions in patients with such previous adverse reactions during benznidazole treatment.

    Science.gov (United States)

    Pérez-Molina, José A; Sojo-Dorado, Jesús; Norman, Francesca; Monge-Maillo, Begoña; Díaz-Menéndez, Marta; Albajar-Viñas, Pedro; López-Vélez, Rogelio

    2013-08-01

    Currently, only two drugs are approved for treating Trypanosoma cruzi infection: benznidazole and nifurtimox. Adverse reactions are frequent with both drugs: they have chemical similarities and common metabolic pathways making cross reactions a possibility. Our objective was to describe the safety/tolerability profile of nifurtimox in patients who had previously discontinued benznidazole due to hypersensitivity reactions. We performed a prospective observational study from September 2009 to December 2011. Patients who discontinued benznidazole therapy due to hypersensitivity reactions (HR) and were later treated with nifurtimox were included. HR to benznidazole were defined as presence of a rash with or without mucosal involvement, fever or laboratory abnormalities (such as eosinophilia, leucopaenia or impaired liver function tests). The drugs were prescribed for 60 days (benznidazole) or 60-90 days (nifurtimox). The National Cancer Institute criteria (CTCAE, 2006, Version 3.0) were used for grading and reporting of adverse reactions (AR). Eighteen patients (16 females, two males, median age 35.5 years, range 15-50 years) with asymptomatic late chronic infection, were included. Median time between benznidazole interruption and start of therapy with nifurtimox was 121.5 days (IQR 72-223 days). Fifteen patients (83.3%) developed an AR to nifurtimox, gastrointestinal complaints and anorexia being the most common, and 13 patients (72%) completed the treatment schedule. Five patients interrupted therapy (27.8%) mainly because of gastrointestinal intolerance and/or nervous system toxicity. Only one patient developed skin lesions, a mild maculopapular rash not requiring specific therapy or treatment withdrawal. There was no severe AR. Nifurtimox as second line therapy in patients who discontinued benznidazole specifically due to HR appears to be safe and does not seem to be associated with a higher incidence of AR. Copyright © 2013 Elsevier B.V. All rights reserved.

  18. Rapid disease progression in human immunodeficiency virus type 1-infected individuals with adverse reactions to trimethoprim-sulfamethoxazole prophylaxis

    NARCIS (Netherlands)

    Veenstra, J.; Veugelers, P. J.; Keet, I. P.; van der Ven, A. J. A. M.; Miedema, F.; Lange, J. M.; Coutinho, R. A.

    1997-01-01

    We studied the relation between the occurrence of adverse reactions to trimethoprim-sulfamethoxazole (TMP-SMZ) prophylaxis and the subsequent course of human immunodeficiency virus (HIV) infection in a cohort of homosexual men. Adverse reactions to TMP-SMZ were associated with a more rapid

  19. Immediate Adverse Reactions to Gadolinium-Based MR Contrast Media: A Retrospective Analysis on 10,608 Examinations

    Directory of Open Access Journals (Sweden)

    Vincenza Granata

    2016-01-01

    Full Text Available Background and Purpose. Contrast media (CM for magnetic resonance imaging (MRI may determine the development of acute adverse reactions. Objective was to retrospectively assess the frequency and severity of adverse reactions associated with gadolinium-based contrast agents (GBCAs injection in patients who underwent MRI. Material and Methods. At our center 10608 MRI examinations with CM were performed using five different GBCAs: Gd-BOPTA (MultiHance, Gd-DTPA (Magnevist, Gd-EOBDTPA (Primovist, Gd-DOTA (Dotarem, and Gd-BTDO3A (Gadovist. Results. 32 acute adverse reactions occurred, accounting for 0.3% of all administration. Twelve reactions were associated with Gd-DOTA injection (0.11%, 9 with Gd-BOPTA injection (0.08%, 6 with Gd-BTDO3A (0.056%, 3 with Gd-EOB-DTPA (0.028%, and 2 with Gd-DTPA (0.018%. Twenty-four reactions (75.0% were mild, four (12.5% moderate, and four (12.5% severe. The most severe reactions were seen associated with use of Gd-BOPTA, with 3 severe reactions in 32 total reactions. Conclusion. Acute adverse reactions are generally rare with the overall adverse reaction rate of 0.3%. The most common adverse reactions were not severe, consisting in skin rash and hives.

  20. [Adverse drug reactions in neonates hospitalized in neonatal intensive care units in Barranquilla, Colombia].

    Science.gov (United States)

    De Las Salas, Roxana; Díaz-Agudelo, Daniela

    2017-04-01

    The appearance of adverse drug reactions in neonates is an important issue due to the lack of drug safety data. To identify the behavior of adverse drug reactions (ADR) in hospitalized neonates at two intensive care units in Barranquilla, Colombia. We conducted a cross-sectional prospective descriptive study based on patientcentered intensive pharmacosurveillance. We followed up and monitored the appearance of ADRs for six months. We used Naranjo's algorithm to assess causality, modified Hartwig and Siegel assessment scale to establish severity and Schumock and Thornton criteria to determine ADR preventability. We detected 123 adverse drug reactions in 78 neonates of the 284 monitored. The cumulative incidence of ADRs was 27.4% (78/284); incidence density was 30.60 ADRs per 1,000 patients/day (78/2,549). The most affected organ system was the digestive (33.6%). Systemic anti-infective drugs were the most involved pharmacological group. Most of the ADRs were mild (58.5%), 83% were classified as probable, 16.2% as possible and 0.8% as definite. ADR incidence was high in newborns, and it increased in preterm infants (less than 38 weeks of age).

  1. A dataset of 200 structured product labels annotated for adverse drug reactions.

    Science.gov (United States)

    Demner-Fushman, Dina; Shooshan, Sonya E; Rodriguez, Laritza; Aronson, Alan R; Lang, Francois; Rogers, Willie; Roberts, Kirk; Tonning, Joseph

    2018-01-30

    Adverse drug reactions (ADRs), unintended and sometimes dangerous effects that a drug may have, are one of the leading causes of morbidity and mortality during medical care. To date, there is no structured machine-readable authoritative source of known ADRs. The United States Food and Drug Administration (FDA) partnered with the National Library of Medicine to create a pilot dataset containing standardised information about known adverse reactions for 200 FDA-approved drugs. The Structured Product Labels (SPLs), the documents FDA uses to exchange information about drugs and other products, were manually annotated for adverse reactions at the mention level to facilitate development and evaluation of text mining tools for extraction of ADRs from all SPLs. The ADRs were then normalised to the Unified Medical Language System (UMLS) and to the Medical Dictionary for Regulatory Activities (MedDRA). We present the curation process and the structure of the publicly available database SPL-ADR-200db containing 5,098 distinct ADRs. The database is available at https://bionlp.nlm.nih.gov/tac2017adversereactions/; the code for preparing and validating the data is available at https://github.com/lhncbc/fda-ars.

  2. Involvement of anticancer drugs in the relief system for adverse drug reactions in Japan.

    Science.gov (United States)

    Maeda, Hideki; Kurokawa, Tatsuo

    2013-12-01

    The compensation scheme for adverse drug reactions in Japan was implemented more than three decades ago as relief system by regulatory agencies. Because of the high frequency of adverse drug reactions, anticancer drugs have been excluded from coverage by the relief system since its implementation. Requests have recently been made by some patient advocates for the expansion of relief coverage to include anticancer drugs. In response to these requests, the Ministry of Health, Labor and Welfare of Japan established a committee to discuss relief from anticancer drug-induced health damages in June 2011. We conducted comprehensive research into the compensation scheme for adverse drug reactions in the world. We also investigated the situation of compensation and the committee for discussing inclusion of anticancer drugs into the relief system in Japan. Many countries including the United States and UK do not have relief or compensation schemes for no-fault compensation. We investigated whether a no-fault compensation system exists in Nordic countries (Sweden, Denmark, Norway and Finland), France, Germany, New Zealand and Taiwan in the world, although they offer different services from Japan. We also reviewed current situation and the fundamental difficulties associated with including anticancer drugs in the systems in Japan. The present study investigated the current situation and the fundamental difficulties associated with including anticancer drugs in the systems in Japan and pointed out part of the reason why the committee could not conclude involvement of anticancer drugs in the relief system.

  3. The importance of monitoring adverse drug reactions in elderly patients: the results of a long-term pharmacovigilance programme.

    Science.gov (United States)

    Carnovale, Carla; Gentili, Marta; Fortino, Ida; Merlino, Luca; Clementi, Emilio; Radice, Sonia; ViGer Group

    2016-01-01

    To recognise and prevent ADRs (including DDIs) in the elderly through a 4-year post-marketing active pharmacovigilance programme. The programme was designed to enhance high quality spontaneous reporting of ADRs in elderly patients by sampling the Italian population and was termed 'Pharmacovigilance in Geriatry (ViGer)'. ADRs were collected for adults aged over 65 years of age treated in nursing homes, continuing care retirement communities and territorial health services in Lombardy. ADRs were evaluated using the Adverse Drug Reaction Probability Scale (Naranjo) and analysed with respect to time, sex, category of ADR, seriousness, suspected medicines, notoriety. We analysed all the potential DDIs. We detected 1073 cases reports corresponding to 2110 ADRs. Vaccines, antibacterials for systemic use and antineoplastic agents were the pharmacotherapeutic subgroups most frequently involved. 18% of ADRs reports were classified as serious. In 752 reports patients were described as in polytherapy; in 55 patients (7.3%) the reported ADR were probably preventable because of DDIs involvement. The ViGer project demonstrated that active pos-marketing pharmacovigilance programmes are a valid strategy to increase awareness on geriatrics pharmacology, reduce underreporting and provide important information on previous unknown ADRs and DDIs, resulting in a therapy optimisation in clinical practice in the geriatric setting.

  4. Respiratory paradoxical adverse drug reactions associated with acetylcysteine and carbocysteine systemic use in paediatric patients: a national survey.

    Science.gov (United States)

    Mallet, Pauline; Mourdi, Nadjette; Dubus, Jean-Christophe; Bavoux, Françoise; Boyer-Gervoise, Marie-José; Jean-Pastor, Marie-Josèphe; Chalumeau, Martin

    2011-01-01

    To report pediatric cases of paradoxical respiratory adverse drug reactions (ADRs) after exposure to oral mucolytic drugs (carbocysteine, acetylcysteine) that led to the withdrawal of licenses for these drugs for infants in France and then Italy. The study followed the recommendations of the European guidelines of pharmacovigilance for medicines used in the paediatric population. Cases voluntarily reported by physicians from 1989 to 2008 were identified in the national French pharmacovigilance public database and in drug company databases. The definition of paradoxical respiratory ADRs was based on the literature. Exposure to mucolytic drugs was arbitrarily defined as having received mucolytic drugs for at least 2 days (>200 mg) and at least until the day before the first signs of the suspected ADR. The non-exclusive paradoxical respiratory ADRs reported in 59 paediatric patients (median age 5 months, range 3 weeks to 34 months, 98% younger than 2 years old) were increased bronchorrhea or mucus vomiting (n = 27), worsening of respiratory distress during respiratory tract infection (n = 35), dyspnoea (n = 18), cough aggravation or prolongation (n = 11), and bronchospasm (n = 1). Fifty-one (86%) children required hospitalization or extended hospitalization because of the ADR; one patient died of pulmonary oedema after mucus vomiting. Parents, physicians, pharmacists, and drug regulatory agencies should know that the benefit risk ratio of mucolytic drugs is at least null and most probably negative in infants according to available evidence.

  5. Adverse reactions to blood donation: A descriptive study of 3520 blood donors in a Nigerian tertiary hospital

    Directory of Open Access Journals (Sweden)

    C Aneke John

    2017-01-01

    Full Text Available Background: The occurrence of adverse reactions to blood donation significantly hampers donor retention and negatively impacts on the universal availability of adequate numbers of blood donor units. Objective: To analyze the spectrum and prevalence of adverse reactions in blood donors in a tertiary hospital-based blood bank in Nigeria. Subjects and Methods: The details of 3520 blood donors who presented for donation over a 12 months period were retrieved from the departmental archives for analysis. These included sociodemographic information, type of donor, type and frequency of adverse reactions to blood donation. Data were analyzed using the Statistical Package for Social Sciences version 20.0 (SPSS Inc., Chicago, IL, USA computer software. Descriptive and inferential statistics were employed to represent the distribution of donor characteristics (as percentages and compare reaction rates by gender and severity, respectively. Results: The prevalence of adverse reactions to blood donation was (56/3520 1.60%; this occurred more frequently in male and family replacement donors (55.35% and 100.0%, respectively. The spectrum of donor adverse reactions included anxiety 25 (44.64%, generalized body weakness 11 (19.64%, hematoma 10 (17.86%, fainting 5 (8.93%, and vomiting 5 (8.93%. Vasovagal reactions were the most frequent adverse reaction encountered among the donors (46/56; 82.14%. Conclusion: Vasovagal reactions are common adverse phenomena in our blood donor set; this has implications on transfusion safety and blood donor retention.

  6. Pharmacovigilance in oncology: pattern of spontaneous notifications, incidence of adverse drug reactions and under-reporting

    Directory of Open Access Journals (Sweden)

    Marília Berlofa Visacri

    2014-04-01

    Full Text Available The high toxicity and narrow therapeutic window of antineoplastic agents makes pharmacovigilance studies essential in oncology. The objectives of the current study were to analyze the pattern of spontaneous notifications of adverse drug reactions (ADRs in oncology patients and to analyze the incidence of ADRs reported by outpatients on antineoplastic treatment in a tertiary care teaching hospital. To compose the pattern of ADR, the notification forms of reactions in oncology patients in 2010 were reviewed, and the reactions were classified based on the drug involved, mechanism, causality, and severity. To evaluate the incidence of reactions, a questionnaire at the time of chemotherapy was included, and the severity was classified based on the Common Terminology Criteria. The profiles of the 10 responses reported to the Pharmacovigilance Sector were type B, severe, possible, and they were primarily related to platinum compounds and taxanes. When the incidence of reactions was analyzed, it was observed that nausea, alopecia, fatigue, diarrhea, and taste disturbance were the most frequently reported reactions by oncology patients, and the grade 3 and 4 reactions were not reported. Based on this analysis, it is proposed that health professionals should be trained regarding notifications and clinical pharmacists should increasingly be brought on board to reduce under-reporting of ADRs.

  7. Pattern of Adverse Drug Reactions to Anticancer Drugs: A Quantitative and Qualitative Analysis.

    Science.gov (United States)

    Singh, Shruti; Dhasmana, D C; Bisht, Manisha; Singh, Prashant Kumar

    2017-01-01

    Anticancer drugs contribute significantly to the global burden of adverse drug reactions (ADRs). Any attempt to quantify their magnitude and provide upgraded knowledge would help oncologists in writing safer prescriptions. This observational follow-up study was conducted on newly diagnosed cancer patients receiving anticancer therapy with an aim to determine the frequency, severity, causality, predictability, and preventability of ADRs. The patients were followed up for 6 months for the appearance of adverse events. Data were analyzed using IBM SPSS Statistics for Windows, Version 22.0. (Armonk, NY) and presented in the form of descriptive statistics. Each patient was prescribed approximately 6.85 ± 1.51 (mean ± standard error) drugs on average. All the patients (100%) receiving anticancer chemotherapy had ADRs. Alopecia, nausea and vomiting, burning tingling, and numbness were the most frequently encountered ADRs. The incidence of alopecia (P < 0.0004), nausea (P < 0.03), and oral ulceration (P < 0.02) was higher in females. Maximum reactions were of Grade 2 (69.53%). Most of the reactions (75.80%) appeared within 10 days of receiving the first cycle. 99.58% reactions were not serious. According to the WHO - The Uppsala Monitoring Centre criteria, 99.47% ADRs fell in possible category. According to the Naranjo's algorithm, 100% ADRs fell in probable category. About 94.80% reactions were found to be predictable. About 56.47% reactions were probably preventable, and 43.53% reactions were not preventable. Multiple ADRs were seen in newly diagnosed cancer patients. Most of them were predictable, of mild-to-moderate severity, nonserious, and preventable. A majority of the ADRs recovered over time.

  8. Cutaneous adverse food reactions in cats: retrospective evaluation of 17 cases in a dermatology referral population (2001-2011).

    Science.gov (United States)

    Vogelnest, L J; Cheng, K Y

    2013-11-01

    To better characterise cutaneous adverse food reactions (AFR) in cats, including the diagnostic challenges. Retrospective evaluation of cases presenting to a dermatology referral service. Cats were identified by a computerised medical record search. AFR was confirmed by clear deterioration on normal food re-challenge after completing an elimination diet, followed by improvement returning to the test diet. Prevalence, and breed, sex or age predispositions were compared with the base referral population. Patient records were reviewed for historical features, clinical presentations, concurrent dermatoses and dietary details. A total of 17 cats were identified with cutaneous AFR, with no breed or sex predisposition determined. Age of onset ranged from 3 months to 9 years, with a mean of 3.5 years. Prevalence was 6% of dermatoses and 10% of cutaneous hypersensitivities in the referral cat population. Cats typically presented with severe, perennial, non-seasonally flaring pruritus affecting the face/head, neck and/or ventral abdomen. Concurrent hypersensitivities were confirmed in 6 cats and/or suspected in another 5 cats. Home-prepared elimination diets were completed by 16 cats; 8 cats had initial poor response to minimum 6-week commercial hydrolysed protein diets. Identified adverse foods included fish in 2 cats, and chicken, beef, commercial dry, and some canned foods, each in 1 cat. The prevalence of cutaneous AFR in the general cat population is likely to be greater than 6%. A range of clinical presentations occur and practical challenges to diagnosis include reliance on strict adherence to dietary exclusion/provocation trials and misleading responses related to concurrent dermatoses and owner perceptions. © 2013 Australian Veterinary Association.

  9. Adverse drug reactions in Nigerian children: a retrospective review of reports submitted to the Nigerian Pharmacovigilance Centre from 2005 to 2012.

    Science.gov (United States)

    Obebi Cliff-Eribo, Kennedy; Sammons, Helen; Star, Kristina; Ralph Edwards, I; Osakwe, Adeline; Choonara, Imti

    2016-11-01

    Adverse drug reactions (ADRs) in children recorded in national pharmacovigilance databases in high-income countries have been analysed. Nigeria has a population of 31 million children and became a member of the WHO Programme for International Drug Monitoring in 2004 since when it has been submitting reports of suspected ADRs to the WHO Global Individual Case Safety Report database, VigiBase. To gain information on reported ADRs in Nigerian children aged 0-17 years in VigiBase from 2005 to 2012. The data were analysed for annual reports, age and sex of patients, type of reporters, suspected drugs and adverse reactions. The most commonly reported ADRs and suspected drugs were ranked, and drugs associated with the fatalities were evaluated. A total of 297 reports of 473 ADRs in 297 children were received from doctors, pharmacists, other health-care professionals and consumers during the period. ADRs were most frequently reported for anti-retrovirals (74, 24%), antibiotics (71, 23%) and anti-malarials (60, 20%). The most frequently reported ADRs were rash (15.2%), fever (10.3%) and pruritus (6.8%). Anti-infective agents were responsible for more than half of the reports. Twenty-one children (7%) died, eight from acute renal failure. Seven of the cases of acute renal failure were associated with contaminated paracetamol/diphenhydramine hydrochloride and herbal medicines used for teething problems. In the majority of cases, the products were contaminated with diethylene glycol. There were 14 cases of Stevens-Johnson syndrome, three of which were fatal. Anti-infective agents (antibiotics, anti-malarials and anti-retrovirals) were associated with a majority of the ADRs. Stevens-Johnson syndrome was the most frequent severe ADR. Some of the fatalities were associated with sub-standard and herbal medications.

  10. Adverse reactions to radiopharmaceuticals in France: analysis of the national pharmacovigilance database.

    Science.gov (United States)

    Laroche, Marie-Laure; Quelven, Isabelle; Mazère, Joachim; Merle, Louis

    2015-01-01

    Radiopharmaceuticals are regarded as safe by the nuclear medicine community, but up to now, no survey has been conducted with from the perspective of pharmacovigilance. To describe the adverse reactions to radiopharmaceuticals (ARRPs) reported to the French Pharmacovigilance Database (FPVD). We selected and described all reports encompassing at least one radiopharmaceutical in the FPVD. The annual incidence of reported ARRPs used in diagnosis was also estimated. From 1989 to 2013, 304 reports of ARRPs were identified (43.0% serious, 12 deaths) in 54.6% women and 45.4% men; the median age was 58 years. Five therapeutic radiopharmaceuticals ((131)I-sodium iodide, (131)I-lipiodol, (89)Sr-chloride, (153)Sm-lexidronam, and (90)Y-ibritumomab-tiuxetan) were involved in 48 reports (97 adverse reactions: 86.6% serious, 9 deaths). Pulmonary disorders represented 44.3% of ARRPs used for therapy, mainly related to (131)I-lipiodol. There were 34 diagnostic radiopharmaceuticals involved in 256 reports (451 adverse reactions: 38.1% serious, 3 deaths); 8 diagnostic products ((99m)Tc-oxidronate, (18)F-fluorodeoxyglucose, (99m)Tc-tin pyrophosphate, (99m)Tc-tetrofosmin, (99m)Tc-dimercaptosuccinic acid, (201)Tl-chloride, (99m)Tc-sestamibi, and (111)In-pentetate) accounted for two-thirds of ARRPs. The most frequent adverse reactions were skin (34.4%), general (18.2%), nervous (9.0%), and gastrointestinal disorders (7.0%). There were 25 cases of altered images and 10 medication errors. The annual incidence of reported adverse reactions ranged from 1.2 × 10(-5) to 3.4 × 10(-5) diagnostic administrations. Reported ARRPs occurred rarely and were more serious in the therapeutic than in the diagnostic field. The notification of ARRPs was able to provide new guidance for safe use, as was the case for (131)I-lipiodol. Therefore, it is important to report ARRPs to a pharmacovigilance system. © The Author(s) 2014.

  11. Heparin-induced thrombocytopenia: a review of concepts regarding a dangerous adverse drug reaction.

    Science.gov (United States)

    Junqueira, Daniela Rezende Garcia; Carvalho, Maria das Graças; Perini, Edson

    2013-01-01

    Heparin is a natural agent with antithrombotic action, commercially available for therapeutic use as unfractionated heparin and low molecular weight heparin. Heparin-induced thrombocytopenia (HIT) is a serious adverse reaction to heparin that promotes antibody-mediated platelet activation. HIT is defined as a relative reduction in platelet count of 50% (even when the platelet count at its lowest level is above>150 x 10(9)/L) occurring within five to 14 days after initiation of the therapy. Thrombocytopenia is the main feature that directs the clinical suspicion of the reaction and the increased risk of thromboembolic complications is the most important and paradoxical consequence. The diagnosis is a delicate issue, and requires a combination of clinical probability and laboratory tests for the detection of platelet activation induced by HIT antibodies. The absolute risk of HIT has been estimated between 1% and 5% under treatment with unfractionated heparin, and less than 1% with low molecular weight heparin. However, high-quality evidence about the risk of HIT from randomized clinical trials is scarce. In addition, information on the frequency of HIT in developing countries is not widely available. This review aims to provide a better understanding of the key features of this reaction and updated information on its frequency to health professionals and other interested parties. Knowledge, familiarity, and access to therapeutic options for the treatment of this adverse reaction are mandatory to minimize the associated risks, improving patient safety. Copyright © 2013 Elsevier Editora Ltda. All rights reserved.

  12. A Multicenter Evaluation of Off-Label Medication Use and Associated Adverse Drug Reactions in Adult Medical ICUs.

    Science.gov (United States)

    Smithburger, Pamela L; Buckley, Mitchell S; Culver, Mark A; Sokol, Sarah; Lat, Ishaq; Handler, Steven M; Kirisci, Levent; Kane-Gill, Sandra L

    2015-08-01

    Prior research indicates that off-label use is common in the ICU; however, the safety of off-label use has not been assessed. The study objective was to determine the prevalence of adverse drug reactions associated with off-label use and evaluate off-label use as a risk factor for the development of adverse drug reactions in an adult ICU population. Multicenter, observational study : Medical ICUs at three academic medical centers. Adult patients (age ≥ 18 yr old) receiving medication therapy. All administered medications were evaluated for Food and Drug Administration-approved or off-label use. Patients were assessed daily for the development of an adverse drug reaction through active surveillance. Three adverse drug reaction assessment instruments were used to determine the probability of an adverse drug reaction resulting from drug therapy. Severity and harm of the adverse drug reaction were also assessed. Cox proportional hazard regression was used to identify a set of covariates that influenced the rate of adverse drug reactions. Overall, 1,654 patient-days (327 patients) and 16,391 medications were evaluated, with 43% of medications being used off-label. One hundred and sixteen adverse drug reactions were categorized dichotomously (Food and Drug Administration or off-label), with 56% and 44% being associated with Food and Drug Administration-approved and off-label use, respectively. The number of adverse drug reactions for medications administered and the number of harmful and severe adverse drug reactions did not differ for medications used for Food and Drug Administration-approved or off-label use (0.74% vs 0.67%; p = 0.336; 33 vs 31 events, p = 0.567; 24 vs 24 events, p = 0.276). Age, sex, number of high-risk medications, number of off-label medications, and severity of illness score were included in the Cox proportional hazard regression. It was found that the rate of adverse drug reactions increases by 8% for every one additional off-label medication

  13. Cutaneous adverse drug reactions seen in a tertiary hospital in Johor, Malaysia.

    Science.gov (United States)

    Ding, Wen Yi; Lee, Chew Kek; Choon, Siew Eng

    2010-07-01

    Adverse drug reactions are most commonly cutaneous in nature. Patterns of cutaneous adverse drug reactions (ADRs) and their causative drugs vary among the different populations previously studied. Our aim is to determine the clinical pattern of drug eruptions and the common drugs implicated, particularly in severe cutaneous ADRs in our population. This study was done by analyzing the database established for all adverse cutaneous drug reactions seen from January 2001 until December 2008. A total of 281 cutaneous ADRs were seen in 280 patients. The most common reaction pattern was maculopapular eruption (111 cases, 39.5%) followed by Stevens-Johnson Syndrome (SJS: 79 cases, 28.1%), drug reaction with eosinophilia and systemic symptoms (DRESS: 19 cases, 6.8%), toxic epidermal necrolysis (TEN: 16 cases, 5.7 %), urticaria/angioedema (15 cases, 5.3%) and fixed drug eruptions (15 cases, 5.3%). Antibiotics (38.8%) and anticonvulsants (23.8%) accounted for 62.6% of the 281 cutaneous ADRs seen. Allopurinol was implicated in 39 (13.9%), carbamazepine in 29 (10.3%), phenytoin in 27 (9.6%) and cotrimoxazole in 26 (9.3%) cases. Carbamazepine, allopurinol and cotrimoxazole were the three main causative drugs of SJS/TEN accounting for 24.0%, 18.8% and 12.5% respectively of the 96 cases seen whereas DRESS was mainly caused by allopurinol (10 cases, 52.6%) and phenytoin (3 cases, 15.8%). The reaction patterns and drugs causing cutaneous ADRs in our population are similar to those seen in other countries although we have a much higher proportion of severe cutaneous ADRs probably due to referral bias, different prescribing habit and a higher prevalence of HLA-B*1502 and HLA-B*5801 which are genetic markers for carbamazepine-induced SJS/TEN and allopurinol-induced SJS/TEN/DRESS respectively. The most common reaction pattern seen in our study population was maculopapular eruptions. Antibiotics, anticonvulsants and NSAIDs were the most frequently implicated drug groups. Carbamazepine

  14. DL-ADR: a novel deep learning model for classifying genomic variants into adverse drug reactions.

    Science.gov (United States)

    Liang, Zhaohui; Huang, Jimmy Xiangji; Zeng, Xing; Zhang, Gang

    2016-08-10

    Genomic variations are associated with the metabolism and the occurrence of adverse reactions of many therapeutic agents. The polymorphisms on over 2000 locations of cytochrome P450 enzymes (CYP) due to many factors such as ethnicity, mutations, and inheritance attribute to the diversity of response and side effects of various drugs. The associations of the single nucleotide polymorphisms (SNPs), the internal pharmacokinetic patterns and the vulnerability of specific adverse reactions become one of the research interests of pharmacogenomics. The conventional genomewide association studies (GWAS) mainly focuses on the relation of single or multiple SNPs to a specific risk factors which are a one-to-many relation. However, there are no robust methods to establish a many-to-many network which can combine the direct and indirect associations between multiple SNPs and a serial of events (e.g. adverse reactions, metabolic patterns, prognostic factors etc.). In this paper, we present a novel deep learning model based on generative stochastic networks and hidden Markov chain to classify the observed samples with SNPs on five loci of two genes (CYP2D6 and CYP1A2) respectively to the vulnerable population of 14 types of adverse reactions. A supervised deep learning model is proposed in this study. The revised generative stochastic networks (GSN) model with transited by the hidden Markov chain is used. The data of the training set are collected from clinical observation. The training set is composed of 83 observations of blood samples with the genotypes respectively on CYP2D6*2, *10, *14 and CYP1A2*1C, *1 F. The samples are genotyped by the polymerase chain reaction (PCR) method. A hidden Markov chain is used as the transition operator to simulate the probabilistic distribution. The model can perform learning at lower cost compared to the conventional maximal likelihood method because the transition distribution is conditional on the previous state of the hidden Markov

  15. Preventability of drug-related harms - part II: proposed criteria, based on frameworks that classify adverse drug reactions.

    Science.gov (United States)

    Aronson, Jeffrey K; Ferner, Robin E

    2010-11-01

    'Preventability' is a crucial concept in the literature on adverse drug effects. However, a systematic review of the definitions of preventability of adverse drug effects has suggested that none fits all circumstances. Furthermore, when the reliability of these definitions has been examined they have been found to be imperfect. To propose and outline a method for determining the theoretical preventability of an adverse drug effect, based on frameworks for classifying adverse drug reactions - the EIDOS and DoTS methods. EIDOS is based on the mechanism of action of the drug. It observes that a drug (an Extrinsic species) causes an adverse effect by interacting with an Intrinsic species that is its target when the two are Distributed together, and that the resulting pathophysiological Outcome (the adverse effect) causes the Sequela (the adverse reaction). DoTS observes that the Dose-relatedness of the adverse effect compared with the beneficial effect is relevant (determining toxic, collateral, or hypersusceptibility effects), that adverse effects have Time-courses (varying from immediate to delayed), and that there are individual Susceptibility factors. We have elicited many published examples that show that each of these factors in the causation of an adverse drug effect can be adduced to assess its preventability. We have constructed a flowchart that illustrates how the processes can be logically analysed. This approach suggests methods for devising prospective preventive strategies and for deciding retrospectively whether an adverse reaction in an individual should have been prevented.

  16. Critically appraised topic on adverse food reactions of companion animals (4): can we diagnose adverse food reactions in dogs and cats with in vivo or in vitro tests?

    Science.gov (United States)

    Mueller, Ralf S; Olivry, Thierry

    2017-08-30

    The gold standard to diagnose adverse food reactions (AFRs) in the dog and cat is currently an elimination diet with subsequent provocation trials. However, those trials are inconvenient and client compliance can be low. Our objective was to systematically review the literature to evaluate in vivo and in vitro tests used to diagnose AFR in small animals. We searched three databases (CAB Abstracts, MEDLINE and Web of Science) for pertinent references on September 16, 2016. Among 71, 544 and 41 articles found in the CAB Abstract, MEDLINE and Web of Science databases, respectively, we selected 22 articles and abstracts from conference proceedings that reported data usable for evaluation of tests for AFR. Serum tests for food-specific IgE and IgG, intradermal testing with food antigens, lymphocyte proliferation tests, fecal food-specific IgE, patch, gastroscopic, and colonoscopic testing were evaluated. Testing for serum food-specific IgE and IgG showed low repeatability and, in dogs, a highly variable accuracy. In cats, the accuracy of testing for food-specific IgE was low. Lymphocyte proliferation tests were more frequently positive and more accurate in animals with AFR, but, as they are more difficult to perform, they remain currently a research tool. All other reported tests were only evaluated by individual studies with small numbers of animals. Negative patch test reactions have a very high negative predictability in dogs and could enable a choice of ingredients for the elimination diet in selected patients. Gastroscopic and colonoscopic testing as well as food-specific fecal IgE or food-specific serum IgG measurements appear less useful. Currently, the best diagnostic procedure to identify AFRs in small animals remains an elimination diet with subsequent provocation trials.

  17. Severe adverse drug reaction following Crotalidae Polyvalent Immune Fab (Ovine) administration for copperhead snakebite.

    Science.gov (United States)

    Lepak, Maryjoy R; Bochenek, Samantha H; Bush, Sean P

    2015-01-01

    To present the case of a severe anaphylactic/anaphylactoid reaction to Crotalidae Polyvalent Immune Fab (Ovine) in a patient bitten by a copperhead snake. A 68-year-old man presented with progressive envenomation after receiving a copperhead snakebite on each hand. Crotalinae Fab antivenom was administered. While the initial and only dose was partially infusing, the patient developed an adverse drug reaction (ADR) of urticaria and hypotension, which resolved with cessation of the infusion, recurred with resumption of the infusion, and ultimately was completed with supportive care. An additional episode of hypotension, urticaria, and angioedema occurred shortly after antivenom therapy completion. Epinephrine was administered, resolving the reaction with complete patient recovery. The event received a Naranjo score of 10, indicating a definite ADR. Treating copperhead snakebites with antivenom is a matter of debate. Concern over adverse events and cost induce some physicians to manage copperhead bites without antivenom because they are generally milder in severity. As demonstrated in this case, severe ADR can occur with Crotalinae Fab antivenom, and its efficacy for copperhead envenoming needs to be better established via placebo-controlled, randomized trials. © The Author(s) 2014.

  18. A replicated association between polymorphisms near TNFα and risk for adverse reactions to radiotherapy

    Science.gov (United States)

    Talbot, C J; Tanteles, G A; Barnett, G C; Burnet, N G; Chang-Claude, J; Coles, C E; Davidson, S; Dunning, A M; Mills, J; Murray, R J S; Popanda, O; Seibold, P; West, C M L; Yarnold, J R; Symonds, R P

    2012-01-01

    Background: Response to radiotherapy varies between individuals both in terms of efficacy and adverse reactions. Finding genetic determinants of radiation response would allow the tailoring of the treatment, either by altering the radiation dose or by surgery. Despite a growing number of studies in radiogenomics, there are no well-replicated genetic association results. Methods: We carried out a candidate gene association study and replicated the result using three additional large cohorts, a total of 2036 women scored for adverse reactions to radiotherapy for breast cancer. Results: Genetic variation near the tumour necrosis factor alpha gene is shown to affect several clinical endpoints including breast induration, telangiectasia and overall toxicity. In the combined analysis homozygosity for the rare allele increases overall toxicity (P=0.001) and chance of being in the upper quartile of risk with odds ratio of 2.46 (95% confidence interval 1.52–3.98). Conclusion: We have identified that alleles of the class III major histocompatibility complex region associate with overall radiotherapy toxicity in breast cancer patients by using internal replication through a staged design. This is the first well-replicated report of a genetic predictor for radiotherapy reactions. PMID:22767148

  19. Monitoring of Adverse Drug Reactions Associated with Antihypertensive Medicines at a University Teaching Hospital in New Delhi

    Directory of Open Access Journals (Sweden)

    Fowad Khurshid

    2012-09-01

    Full Text Available Aim To monitor the adverse drug reactions (ADRs caused by antihypertensive medicines prescribed in a university teaching hospital.Methods:he present work was an open, non-comparative, observational study conducted on hypertensive patients attending the Medicine OPD of Majeedia Hospital, Jamia Hamdard, New Delhi, India by conducting patient interviews and recording the data on ADR monitoring form as recommended by Central Drugs Standard Control Organization (CDSCO, Government of India.Results:A total of 21 adverse drug reactions were observed in 192 hypertensive patients. Incidence of adverse drug reactions was found to be higher in patients more than 40 years in age, and females experienced more ADRs (n = 14, 7.29 % than males, 7 (3.64 %. Combination therapy was associated with more number of adverse drug reactions (66.7 % as against monotherapy (33.3 %. Calcium channel blockers were found to be the most frequently associated drugs with adverse drug reactions (n = 7, followed by diuretics (n = 5, and beta- blockers (n = 4. Among individual drugs, amlodipine was found to be the commonest drug associated with adverse drug reactions (n = 7, followed by torasemide (n = 3. Adverse drug reactions associated with central nervous system were found to be the most frequent (42.8 % followed by musculo-skeletal complaints (23.8 % and gastro-intestinal disorders (14.3 %. Conclusions:The present pharmacovigilance study represents the adverse drug reaction profile of the antihypertensive medicines prescribed in our university teaching hospital. The above findings would be useful for physicians in rational prescribing. Calcium channel blockers were found to be the most frequently associated drugs with adverse drug reactions.

  20. Potentially inappropriate prescribing and the risk of adverse drug reactions in critically ill older adults

    Directory of Open Access Journals (Sweden)

    Galli TB

    2016-12-01

    Full Text Available Background: Potentially inappropriate medication (PIM use in the elderly is associated with increased risk of adverse drug reactions (ADRs, but there is limited information regarding PIM use in the intensive care unit (ICU setting. Objective: The aim of the study is to describe the prevalence and factors associated with the use of PIM and the occurrence of PIM-related adverse reactions in the critically ill elderly. Methods: This study enrolled all critically ill older adults (60 years or more admitted to medical or cardiovascular ICUs between January and December 2013, in a large tertiary teaching hospital. For all patients, clinical pharmacists listed the medications given during the ICU stay and data on drugs were analyzed using 2012 Beers Criteria, to identify the prevalence of PIM. For each identified PIM the medical records were analyzed to evaluate factors associated with its use. The frequency of ADRs and, the causal relationship between PIM and the ADRs identified were also evaluated through review of medical records. Results: According to 2012 Beers Criteria, 98.2% of elderly patients used at least one PIM (n=599, of which 24.8% were newly started in the ICUs. In 29.6% of PIMs, there was a clinical circumstance that justified their prescription. The number of PIMs was associated with ICU length of stay and total number of medications. There was at least one ADR identified in 17.8% of patients; more than 40% were attributed to PIM, but there was no statistical association. Conclusions: There is a high prevalence of PIM used in acutely ill older people, but they do not seem to be the major cause of adverse drug reactions in this population. Although many PIMs had a clinical circumstance that led to their prescription during the course of ICU hospitalization, many were still present upon hospital discharge. Therefore, prescription of PIMs should be minimized to improve the safety of elderly patients.

  1. Autoimmune Fibrotic Adverse Reactions in One-Year Treatment with Cabergoline for Women with Prolactinoma.

    Science.gov (United States)

    Doğan, Berçem Ayçiçek; Arduc, Ayse; Tuna, Mazhar Müslüm; Berker, Dilek; Demirci, Nilgün; Demirtaş, Semra; Çiçekcioğlu, Hülya; Güler, Serdar

    2016-01-01

    Cabergoline is related to an elevated risk of fibrotic adverse reactions including cardiac valvular and pleuropulmonary fibrosis. We investigated pulmonary and cardiac valve fibrosis and immunological markers before and after 3 and 12 months of treatment with cabergoline in women with prolactinoma. The study included thirty-two women with newly diagnosed prolactinoma and 28 healthy women. CAB cumulative dose was 7.8±5.5 mg after 3-month therapy, and 31±22 mg after 12-month follow-up. The risk of autoimmune adverse fibrotic reactions related to CAB treatment including cardiac valvulopathy and pulmonary fibrosis were assessed by a transthoracic echocardiography and pulmonary function tests, respectively. Immunological markers including Antistreptolysin O, Rheumatoid factor, Immunglobuline E, Antinuchlear antibody were also evaluated. Before the start of CAB therapy, the total prevalence of trace grade of mitral, aortic, pulmonic, and tricuspid valve regurgitations were found as 34%, 3%, 6.3%, and 39 % respectively in women with prolactinoma. After improving of prolactin levels with CAB treatment, no change was found in the prevalence of the all valve regurgitations. There was no deterioration in pulmonary function tests. Rheumatoid factor was found higher in newly diagnosed women with prolactinoma than in healthy women (p=0.01), and this was improved by CAB therapy (p=0.005). The prospective study indicated that sufficient cabergoline doses for a period of one year treatment of prolactinoma were not found to be related to fibrotic adverse reactions including cardiac valvular and pulmonary fibrosis or increased levels of immunological marker, apart from rheumatoid factor. For the first time Rf was found higher in newly diagnosed women with prolactinoma and was improved after cabergoline therapy.

  2. Immune-related and adverse drug reactions to low versus high initial doses of Viscum album L. in cancer patients.

    Science.gov (United States)

    Schad, Friedemann; Thronicke, Anja; Merkle, Antje; Matthes, Harald; Steele, Megan L

    2017-12-01

    Immune-related adverse drug reactions (ADRs) to immunotherapy agents have been associated with beneficial clinical outcomes in oncology. Viscum album L. (VA, European mistletoe) is frequently used as an immunomodulatory agent alongside conventional cancer treatment in Europe. VA has been associated with improved quality of life and a reduction in chemotherapy-related ADRs. Beneficial effects of VA are believed to be related to its immunomodulatory properties. Current guidelines recommend commencing with a low dose and increasing slowly overtime, however, off-label prescribing of high initial doses is common. We investigated ADR profiles related to subcutaneous VA therapy commencing with low, recommended doses versus higher than recommended doses. Retrospective cohort study. Medical records of 1361 cancer patients treated between 2003 and 2013 were assessed. Patients were divided into two groups based on whether the dose of their first VA injection adhered to current guidelines. Patient characteristics and suspected VA-related ADRs were compared between dose groups. Of 1361 cancer patients, 516 (38%) started with a recommended, low dose of VA(≤0.02 mg) and 845 (62%) started with a higher dose(>0.02 mg). Groups did not differ by age or gender, but significant differences were observed for type (p cancer (p = 0.05). Starting with a high dose of VA was significantly associated with a higher incidence of VA-related ADRs compared to starting with a low dose (20.7% versus 0.8%, p < 0.001). Adjusting for age, gender, tumour type and stage of disease, produced an odds ratio of 37.5 (95% CI = 15.7-122.8, p < .001). Almost all ADRs, irrespective of the initial VA dose, were of mild or moderate intensity. Most ADRs were immune-related, general disorders and administration site conditions, many of which are desired reactions, such as pyrexia and local reactions. Overall, no serious ADRs occurred. Starting VA therapy with a higher than recommended dose

  3. Adverse reaction to sublingual Parietaria vaccine following an ultra-rush induction.

    Science.gov (United States)

    Scala, G; Ciccarelli, A; Calabrò, C

    2014-05-01

    In the treatment of respiratory allergies Sublingual Immunotherapy (SLIT) represents a valid alternative to Subcutaneous Immunotherapy (SCIT) for its better safety profile. We describe a case of acute severe asthma following the first maintenance dose of SLIT in a boy allergic to Parietaria pollen. At the initiation of therapy, the patient was in healthy condition and his asthma appeared to be under control. An ultra-rush induction had given no reaction. Despite the good safety profile of SLIT, clinicians should be aware of the risk of adverse effects when prescribing SLIT for respiratory allergies.

  4. [Nalmefene and Opioid Withdrawal Syndrome: Analysis of the Global Pharmacovigilance Database for Adverse Drug Reactions].

    Science.gov (United States)

    Dahmke, Hendrike; Kupferschmidt, Hugo; Kullak-Ublick, Gerd A; Weiler, Stefan

    2015-10-14

    Nalmefene (Selincro®) is a selective opioid receptor antagonist, licensed in April 2014 in Switzerland for the reduction of alcohol consumption in adults with a high drinking risk level. 200 reports of adverse drug reactions of nalmefene have been documented worldwide in the WHO global pharmacovigilance database between 7th March 1997 to 1st March 2015. In 21 cases (10,5%) nalmefene and an opioid were administered concomitantly, causing withdrawal symptoms. Until now, the regional pharmacovigilance center in Zurich received four cases of nalmefene combined with opioids. This combination should be avoided.

  5. Adverse drug reactions of nonsteroidal anti-inflammatory drugs in orthopedic patients

    OpenAIRE

    Gor, Alpa Pragnesh; Saksena, Miti

    2011-01-01

    Objectives: To identify the ADRs due to NSAIDs and to know how to monitor the drug′s effect. Materials and Methods: A descriptive study was undertaken in the Orthopedic Outpatients Department of a tertiary care teaching hospital. Hundred patients were enrolled in this study to observe the risk of adverse drug reactions (ADRs) due to NSAIDs. All the ADRs were further analyzed in relation to age and sex, type of drug and its pattern. Probability scale was used for the causality assessment of th...

  6. [Understanding and reducing the risk of adverse drug reactions in pediatric patients].

    Science.gov (United States)

    Gotta, Verena; van den Anker, Johannes; Pfister, Marc

    2015-12-01

    Developmental pharmacology influences the safety profile of drugs in pediatrics. Altered pharmacokinetics and/ or pharmacodynamics of drugs make pediatric patients susceptible to adverse drug reactions (ADRs), especially infants and newborns. Since the efficacy/ safety balance of most available drugs has not been formally evaluated in pediatric clinical trials, optimal dosing is rarely known in pediatrics. Suboptimal pediatric drug formulations make dose optimization even more difficult exposing pediatric patients to medication errors like overdosing and associated ADRs. We provide an overview of pediatric ADRs and discuss recent regulatory and pharmacological measures to understand and reduce risk of ADRs in pediatric patients.

  7. Pharmacy student driven detection of adverse drug reactions in the community pharmacy setting

    DEFF Research Database (Denmark)

    Christensen, Søren Troels; Søndergaard, Birthe; Honoré, Per Hartvig

    2011-01-01

    PURPOSE: Post-marketing safety studies of adverse drug reactions (ADRs) form an important part of pharmacovigilance. Countries having a formal pharmacovigilance system to a large extent rely on voluntary ADR reporting from health professionals through spontaneous report systems. The contribution...... focusing on ADR detection and reporting in general. Ibuprofen was chosen as the drug of study. Pharmacy students approached recurrent drug users purchasing the drug. Participating users were asked about experienced ADRs linked to ibuprofen use. Reported ADRs were collected and analysed. RESULTS: Hundred...

  8. Adverse drug reactions profile of antimicrobials: A 3-year experience, from a tertiary care teaching hospital of India

    Directory of Open Access Journals (Sweden)

    Richa

    2015-01-01

    Full Text Available Aim of Study: To evaluate adverse drug reaction (ADR profile of antimicrobials over 3-year period. Material and Methods: A retrospective cross-sectional study was undertaken using suspected adverse drug data collection form available under Pharmacovigilance Programme of India (PvPI. Results: A total of 2,586 ADR events were recorded in 3 years, out of which 392 (15.15% were because of antimicrobials. Male: female was 1.02:1. Medicine department contributed maximally (98.97%. The intravenous (IV route of drug administration accounted maximum ADRs (53.32%, followed by oral route (45.41%. Monotherapy was responsible for 80.87%, whereas combination therapy for 19.13%. Combinations therapy was irrational in 79.67%. The most common antibiotic resulting in ADRs was injection ceftriaxone (35.71%, followed by tab. azithromycin (7.39%, tab. ofloxacin + ornidazol (5.35%, ofloxacin (3.57%, ciprofloxacin (2.29%, amoxicillin (2.55%, tab. cefixime (2.29%, inj. linezolid (2.04%. Rash remained the most common ADR, followed by diarrhoea and gastritis. Most common organ system involved was dermatological (47.44%, followed by gastrointestinal (GI (39.28%, central nervous system (CNS (5.35%, cardiovascular system (CVS (3.57% and renal and genitourinary (1.78%. While 47.96% ADR′s were latent, 26.785% were acute and 25.26% were sub-acute. Moreover, 89.79% of ADRs were moderate in nature, whereas 26.88% were severe and 3.33% mild in nature. Furthermore, 92.86% were non-serious and 7.14% serious in nature. Also, 65.06% of antimicrobial caused ADRs were type A and 34.64% were type B reactions. As per World Health Organization-The Uppsala Monitoring Centre (WHO-UMC scale, 73.98% of ADRs were probable/likely and 26.02% as possible. However, 99.47% of ADRs required intervention. Conclusion: The current study suggest that ADRs due to antimicrobials is a significant health problem.

  9. [Pilot study evaluating the ratio of adverse drug reactions related to antimicrobials over their consumption in 2012-2013].

    Science.gov (United States)

    Bérard, C; Cerruti, L; Cotteret, C; Lebel, D; Bussières, J-F

    2016-03-01

    As part of our antimicrobials stewardship program, we were interested in the use of antimicrobials and prevalence of adverse drug reactions associated with the use of these drugs. The retrospective and descriptive study was conducted over a one year-period between April 1st 2012 and March 31st 2013 in a mother-child Hospital. We determined the ratio: number of adverse drug reactions over 10,000 defined daily dose or 10,000days of therapy. We identified the ratios higher than average for which the confidence interval did not cross the calculated average. The severity of the adverse drug reactions was codified using the Common Terminology Criteria for Adverse Events. We found 570 adverse drug reactions including 100 (17.5%) adverse drug reactions related to antimicrobials during the financial year 2012-2013. It represented 96 patients. Thus, five antimicrobials, for which the confidence interval does not cross the calculated average value, may be targeted in risk management because they have a higher ratio than average: piperacillin (290 [113-722]), valganciclovir (244 [43-1260]), ceftriaxone (114 [56-234]), acyclovir (76 [26-220]) and liposomal amphotericin B (72 [20-258]). In a mother-child university hospital, we calculated a ratios of 19 [15-23] and 13 [10-15], it allows us targeting some antimicrobials in our approach to prevention and management of adverse drug reactions. Copyright © 2015 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

  10. Bacterial infection as a likely cause of adverse reactions to polyacrylamide hydrogel fillers in cosmetic surgery

    DEFF Research Database (Denmark)

    Christensen, Lise; Breiting, Vibeke; Bjarnsholt, Thomas

    2013-01-01

    in the presence of polyacrylamide filler in cosmetic surgery, possibly due to a biofilm mode of growth. Adequate skin preparation and use of sterile technique in these procedures are mandatory, but antibiotic prophylaxis prior to injection of nondegradable gels like polyacrylamide should be explored as well.......Background. The etiology of long-lasting adverse reactions to gel fillers used in cosmetic surgery is not known. Bacterial infection and immunological reaction to the product have been suggested. Methods. We performed a case-control study, with 77 biopsies and 30 cytology specimens originating from...... patients and 24 controls were systematically examined for the presence of bacteria by culture, 16S rRNA gene sequencing, Gram stain, and fluorescence in situ hybridization. Results. Bacteria, mostly normal skin bacteria such as Staphylococcus epidermidis and Propionibacterium acnes, were identified...

  11. Drug reaction with eosinophilia and systemic symptoms (DRESS) : an original multisystem adverse drug reaction. Results from the prospective RegiSCAR study

    NARCIS (Netherlands)

    Kardaun, S. H.; Sekula, P.; Valeyrie-Allanore, L.; Liss, Y.; Chu, C. Y.; Creamer, D.; Sidoroff, A.; Naldi, L.; Mockenhaupt, M.; Roujeau, J. C.

    2013-01-01

    BackgroundCases of severe drug hypersensitivity, demonstrating a variable spectrum of cutaneous and systemic involvement, are reported under various names, especially drug reaction with eosinophilia and systemic symptoms (DRESS). Case definition and overlap with other severe cutaneous adverse

  12. Prevention and Management of Adverse Reactions Induced by Iodinated Contrast Media.

    Science.gov (United States)

    Wu, Yi Wei; Leow, Kheng Song; Zhu, Yujin; Tan, Cher Heng

    2016-04-01

    Iodinated radiocontrast media (IRCM) is widely used in current clinical practice. Although IRCM is generally safe, serious adverse drug reactions (ADRs) may still occur. IRCM-induced ADRs may be subdivided into chemotoxic and hypersensitivity reactions. Several factors have been shown to be associated with an increased risk of ADRs, including previous contrast media reactions, history of asthma and allergic disease, etc. Contrast media with lower osmolality is generally recommended for at-risk patients to prevent ADRs. Current premedication prophylaxis in at-risk patients may reduce the risk of ADRs. However, there is still a lack of consensus on the prophylactic role of premedication. Contrast-induced nephropathy (CIN) is another component of IRCM-related ADRs. Hydration remains the mainstay of CIN prophylaxis in at-risk patients. Despite several preventive measures, ADRs may still occur. Treatment strategies for potential contrast reactions are also summarised in this article. This article summarises the pathophysiology, epidemiology and risk factors of ADRs with emphasis on prevention and treatment strategies. This will allow readers to understand the rationale behind appropriate patient preparation for diagnostic imaging involving IRCM.

  13. Adverse reactions of hyperbaric oxygen therapy - case description of a generalised seizure

    Directory of Open Access Journals (Sweden)

    Grobelska Kinga

    2016-03-01

    Full Text Available Hyperbaric oxygen therapy (HBOT is a safe treatment, provided fulfilling certain rules of patient qualifications to treatment, as well as supervision over the course of therapy by qualified medical staff. Side effects reported in the literature are rare, and are usually mild and transient. Professional medical staff allows minimising the adverse events occurrence. The scale of complications is unknown, especially in Polish hyperbaric center. Careful analysis could be used to develop prevention procedures for patients of hyperbaric oxygen therapy. Hyperbaric Oxygen Centre and Wound Treatment in Bydgoszcz during 28 months performed hyperbaric oxygen therapy (HBOT in case of 423 patients. During this period, adverse events occurred occasionally. 17 cases have been reported. Authors described study case 77 year-old patient who was admitted due to non-healing wound-left lower abdomen (state after radiotherapy. During the fourth session, on decompression phase patient have had a generalized seizure (tonic-clonic. The decompression was stopped, the oxygen supply was disconnected but only after the drug administration seizures terminated. The most likely causative agent of the adverse reactions of the patient treated with HBOT was the oxygen toxic effect on the brain tissue. However, analyzing the circumstances of the seizure termination: phase of decompression at the pressure 2ATA and lack of oxygen disconnection response, it cannot be excluded other causes of this complication.

  14. Adverse reactions to the Bacillus Calmette-Guérin (BCG) vaccine in new-born infants

    DEFF Research Database (Denmark)

    Nørrelykke Nissen, Thomas; Birk, Nina Marie; Kjærgaard, Jesper

    2016-01-01

    OBJECTIVE: To evaluate adverse reactions of the Bacillus Calmette-Guérin (BCG) Statens Serum Institut (SSI) (Danish strain 1331) used as intervention in a randomized clinical trial. DESIGN: A randomized clinical multicenter trial, The Danish Calmette Study, randomizing newborns to BCG...... and eighty four families consented to participate and 4262 children, gestational age 32 weeks and above, were randomized: 2129 to BCG vaccine and 2133 to no vaccine. None of the participants withdrew because of adverse reactions. MAIN OUTCOME AND MEASURE: Trial-registered adverse reactions after BCG...... vaccination at birth. Follow-up at 3 and 13 months by telephone interviews and clinical examinations. RESULTS: Among the 2118 BCG-vaccinated children we registered no cases of severe unexpected adverse reaction related to BCG vaccination and no cases of disseminated BCG disease. Two cases of regional...

  15. Historical perspectives and the future of adverse reactions associated with haemopoietic stem cells cryopreserved with dimethyl sulfoxide

    DEFF Research Database (Denmark)

    Cox, Michael A; Kastrup, Jens; Hrubiško, Mikulas

    2012-01-01

    A retrospective review of the published literature identified several hundred adverse reactions (e.g. nausea, chills, cardiac arrhythmias, neurological symptoms and respiratory arrest) associated with the transplantation of stem cells cryopreserved with dimethyl sulfoxide. The occurrences of thes...

  16. The 24th report on survey of the adverse reaction to radiopharmaceuticals (The 27th survey in 2001)

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2003-02-01

    The survey in the title involves occasions of adverse reactions and drug defects of radiopharmaceuticals and its twenty seventh one in 2001 (April 1, 2001-March 31, 2002) is reported herein. The survey was conducted by questionnaire to 1,210 facilities, of which 1,048 (86.6%) answered. Adverse reaction (32 cases/1,390,843=0.0019% occasion) and drug defect (5, 0.0004%) were reported from 27 facilities: They were 0.0017-0.0025% and 0.0001-0.0005%, respectively, after 1997. Frequent occasion of adverse reaction was seen in {sup 131}I-methyl-norcholesterol (0.1704%) and in {sup 131}I-sodium hippurate (0.1020%). The former was considered to be due to the ingredient, ethanol. Occasion of the adverse reaction of other drugs was less than 0.1%. The drug defects were due to the abnormal distribution (4 cases) and formulation defect (1). (N.I.)

  17. A comparison of adverse reaction rates for PAS C versus plasma platelet units.

    Science.gov (United States)

    Cohn, Claudia S; Stubbs, James; Schwartz, Joseph; Francis, Richard; Goss, Cheryl; Cushing, Melissa; Shaz, Beth; Mair, David; Brantigan, Barbara; Heaton, W Andrew

    2014-08-01

    Plasma constituents have been implicated in some types of platelet (PLT) transfusion reactions. Leukoreduced apheresis PLTs stored in InterSol have 65% less plasma than apheresis PLTs stored in 100% plasma (PPs). This study compared transfusion reaction rates in InterSol PLTs (PLT additive solution [PAS] C) versus PPs. The study design was an open-label, nonrandomized retrospective review. Statistical methods were applied to substantiate noninferiority and superiority of PAS C compared to PP in terms of transfusion reaction rates. Adverse reactions (ARs) were categorized using the Biovigilance Component of the National Healthcare Safety Network. Active surveillance was used to monitor all transfusions, both with ARs and without ARs. A total of 14,005 transfusions from six study sites were included, with 9845 PP transfusions given to 2202 patients and 4160 PAS C to 1444 patients. A total of 165 ARs were reported. Percentages of transfusions with ARs were 1.37% for PPs, 0.55% for PAS C, and 1.13% overall. The relative risk (RR) for PAS C versus PPs was calculated as 0.403 with an upper confidence limit (UCL) of 0.663. Overall, ARs with the highest incidence were allergic transfusion reactions (ATRs) and febrile nonhemolytic transfusion reactions (FNHTRs), at 0.66 and 0.40% of total transfusions reported, respectively. The relative risks (UCLs) for ATRs and FNHTRs, respectively, were 0.350 (0.686) and 0.336 (0.827). PAS C PLTs were statistically superior and noninferior to PPs with respect to the transfusion-related AR rate. PAS C noninferiority and superiority were also demonstrated for ATRs and FNHTRs, separately. © 2014 AABB.

  18. [Analysis and countermeasures of adverse drug reactions of traditional Chinese medicine injections in children].

    Science.gov (United States)

    Zhang, Xi-Lian; Li, Meng; Rong, Ping; Ma, Rong

    2012-09-01

    We aimed to analyse the adverse drug reactions (ADR) in children due to traditional Chinese medicine (TCM) injections and the related factors, and explored the rational use of medicines and safty countermeasures in clinical. We preformed statistical analyses on data from the CNKI and researched on literatures, from April 1987 to May 2012, relevant to the TCM injections which lead to reactions of clinical adverse, to conduct a analysis of the species, cases, clinical manifestations and related factors of these injections. The incidence of ADR in children leaded by TCM injections is high and the manifestations were chiefly characterized by the luscious of skin and appendages. In addition to the correlation with the physiological and pathologic characteristic in childhood, the ADR is also closely related with preparing technology, irrational use and imperfect supervisory system. Because of the high incidence, we should taking appropriate measures, such as constructing strict supervision system and strengthening rational drug use, to reduce the occurrence of ADRs to the greatest extent.

  19. On the creation of a clinical gold standard corpus in Spanish: Mining adverse drug reactions.

    Science.gov (United States)

    Oronoz, Maite; Gojenola, Koldo; Pérez, Alicia; de Ilarraza, Arantza Díaz; Casillas, Arantza

    2015-08-01

    The advances achieved in Natural Language Processing make it possible to automatically mine information from electronically created documents. Many Natural Language Processing methods that extract information from texts make use of annotated corpora, but these are scarce in the clinical domain due to legal and ethical issues. In this paper we present the creation of the IxaMed-GS gold standard composed of real electronic health records written in Spanish and manually annotated by experts in pharmacology and pharmacovigilance. The experts mainly annotated entities related to diseases and drugs, but also relationships between entities indicating adverse drug reaction events. To help the experts in the annotation task, we adapted a general corpus linguistic analyzer to the medical domain. The quality of the annotation process in the IxaMed-GS corpus has been assessed by measuring the inter-annotator agreement, which was 90.53% for entities and 82.86% for events. In addition, the corpus has been used for the automatic extraction of adverse drug reaction events using machine learning. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. Clinical efficacy of nutraceutical diet for cats with clinical signs of cutaneus adverse food reaction (CAFR).

    Science.gov (United States)

    Mazzeranghi, F; Zanotti, C; Di Cerbo, A; Verstegen, J P; Cocco, R; Guidetti, G; Canello, S

    2017-03-01

    Food allergies and food intolerances are clinically difficult to discriminate. Most often, along with cutaneous adverse food reactions or CAFR, they are classified as adverse food reactions, whose causes are numerous, including toxic compounds. Eighteen indoor-housed domestic cats with evident clinical symptoms related to CAFR (drooling, back and neck intense itching, neck eczema, chronic conjunctivitis and stomatitis) involving skin lesions were studied. Cytological evaluations of ear, skin and gingival swabs revealed an increased turnover of keratinocytes while the oxytetracycline ELISA determination showed an unexpected high amount of oxytetracycline in all cats at the first visit. All cats were then randomly assigned to receive a standard (SD group) or a nutraceutical diet (ND group) for 60 days. In the ND group a significant reduction of the mean serum concentration of oxytetracycline, pruritus intensity and skin lesion severity (**pcat sera and CAFR-related symptoms has never been described, this study highlights the benefit of a specific nutraceutical diet supplementation in improving clinical symptoms and skin lesions in cats with CARF.

  1. Adverse drug reaction and toxicity caused by commonly used antimicrobials in canine practice

    Directory of Open Access Journals (Sweden)

    K. Arunvikram

    2014-05-01

    Full Text Available An adverse drug reaction (ADR is a serious concern for practicing veterinarians and other health professionals, and refers to an unintended, undesired and unexpected response to a drug that negatively affects the patient's health. It may be iatrogenic or genetically induced, and may result in death of the affected animal. The ADRs are often complicated and unexpected due to myriad clinical symptoms and multiple mechanisms of drug-host interaction. Toxicity due to commonly used drugs is not uncommon when they are used injudiciously or for a prolonged period. Licosamides, exclusively prescribed against anaerobic pyoderma, often ends with diarrhoea and vomiting in canines. Treatment with Penicillin and β-lactam antibiotics induces onset of pemphigious vulgare, drug allergy or hypersensitivity. Chloroamphenicol and aminoglycosides causes Gray's baby syndrome and ototoxicity in puppies, respectively. Aminoglycosides are very often associated with nephrotoxicity, ototoxicity and neuromuscular blockage. Injudicious use of fluroquinones induces the onset of arthropathy in pups at the weight bearing joints. The most effective therapeutic measure in managing ADR is to treat the causative mediators, followed by supportive and symptomatic treatment. So, in this prospective review, we attempt to bring forth the commonly occurring adverse drug reactions, their classification, underlying mechanism, epidemiology, treatment and management as gleaned from the literature available till date and the different clinical cases observed by the authors.

  2. Analysis of adverse drug reactions using drug and drug target interactions and graph-based methods.

    Science.gov (United States)

    Lin, Shih-Fang; Xiao, Ke-Ting; Huang, Yu-Ting; Chiu, Chung-Cheng; Soo, Von-Wun

    2010-01-01

    The purpose of this study was to integrate knowledge about drugs, drug targets, and topological methods. The goals were to build a system facilitating the study of adverse drug events, to make it easier to find possible explanations, and to group similar drug-drug interaction cases in the adverse drug reaction reports from the US Food and Drug Administration (FDA). We developed a system that analyses adverse drug reaction (ADR) cases reported by the FDA. The system contains four modules. First, we integrate drug and drug target databases that provide information related to adverse drug reactions. Second, we classify drug and drug targets according to anatomical therapeutic chemical classification (ATC) and drug target ontology (DTO). Third, we build drug target networks based on drug and drug target databases. Finally, we apply topological analysis to reveal drug interaction complexity for each ADR case reported by the FDA. We picked 1952 ADR cases from the years 2005-2006. Our dataset consisted of 1952 cases, of which 1471 cases involved ADR targets, 845 cases involved absorption, distribution, metabolism, and excretion (ADME) targets, and 507 cases involved some drugs acting on the same targets, namely, common targets (CTs). We then investigated the cases involving ADR targets, ADME targets, and CTs using the ATC system and DTO. In the cases that led to death, the average number of common targets (NCTs) was 0.879 and the average of average clustering coefficient (ACC) was 0.067. In cases that did not lead to death, the average NCTs was 0.551, and the average of ACC was 0.039. We implemented a system that can find possible explanations and cluster similar ADR cases reported by the FDA. We found that the average of ACC and the average NCTs in cases leading to death are higher than in cases not leading to death, suggesting that the interactions in cases leading to death are generally more complicated than in cases not leading to death. This indicates that our system

  3. Fatal adverse drug reactions of anticancer drugs detected by all-case post-marketing surveillance in Japan.

    Science.gov (United States)

    Mori, Jinichi; Tanimoto, Tetsuya; Miura, Yuji; Kami, Masahiro

    2015-06-01

    All-case post-marketing surveillance of newly approved anticancer drugs is usually conducted on all patients in Japan. The present study investigates whether all-case post-marketing surveillance identifies fatal adverse drug reactions undetected before market entry. We examined fatal adverse drug reactions identified via all-case post-marketing surveillance by reviewing the disclosed post-marketing surveillance results, and determined the time points in which the fatal adverse drug reactions were initially reported by reviewing drug labels. We additionally scanned emergency alerts on the Japanese regulatory authority website to assess the relationship between all-case post-marketing surveillance and regulatory action. Twenty-five all-case post-marketing surveillances were performed between January 1999 and December 2009. Eight all-case post-marketing surveillances with final results included information on all fatal cases. Of these, the median number of patients was 1287 (range: 106-4998), the median number of fatal adverse drug reactions was 14.5 (range: 4-23). Of the 111 fatal adverse drug reactions detected in the eight post-marketing surveillances, only 28 (25.0%) and 22 (19.6%) were described on the initial global and the initial Japanese drug label, respectively, and 58 (52.3%) fatal adverse drug reactions were first described in the all-case post-marketing surveillance reports. Despite this, the regulatory authority issued only four warning letters, and two of these were prompted by case reports from the all-case post-marketing surveillance. All-case post-marketing surveillance of newly approved anticancer drugs in Japan was useful for the rigorous compilation of non-specific adverse drug reactions, but it rarely detected clinically significant fatal adverse drug reactions. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  4. Adverse reactions to blood donation: A descriptive study of 3520 blood donors in a Nigerian tertiary hospital

    OpenAIRE

    C Aneke John; U Ezeh Theodora; A Nwosu Gloria; E Anumba Chika

    2017-01-01

    Background: The occurrence of adverse reactions to blood donation significantly hampers donor retention and negatively impacts on the universal availability of adequate numbers of blood donor units. Objective: To analyze the spectrum and prevalence of adverse reactions in blood donors in a tertiary hospital-based blood bank in Nigeria. Subjects and Methods: The details of 3520 blood donors who presented for donation over a 12 months period were retrieved from the departmental archives for ana...

  5. Evaluation of Internet Social Networks using Net scoring Tool: A Case Study in Adverse Drug Reaction Mining.

    Science.gov (United States)

    Katsahian, Sandrine; Simond Moreau, Erica; Leprovost, Damien; Lardon, Jeremy; Bousquet, Cedric; Kerdelhué, Gaétan; Abdellaoui, Redhouane; Texier, Nathalie; Burgun, Anita; Boussadi, Abdelali; Faviez, Carole

    2015-01-01

    Suspected adverse drug reactions (ADR) reported by patients through social media can be a complementary tool to already existing ADRs signal detection processes. However, several studies have shown that the quality of medical information published online varies drastically whatever the health topic addressed. The aim of this study is to use an existing rating tool on a set of social network web sites in order to assess the capabilities of these tools to guide experts for selecting the most adapted social network web site to mine ADRs. First, we reviewed and rated 132 Internet forums and social networks according to three major criteria: the number of visits, the notoriety of the forum and the number of messages posted in relation with health and drug therapy. Second, the pharmacist reviewed the topic-oriented message boards with a small number of drug names to ensure that they were not off topic. Six experts have been chosen to assess the selected internet forums using a French scoring tool: Net scoring. Three different scores and the agreement between experts according to each set of scores using weighted kappa pooled using mean have been computed. Three internet forums were chosen at the end of the selection step. Some criteria get high score (scores 3-4) no matter the website evaluated like accessibility (45-46) or design (34-36), at the opposite some criteria always have bad scores like quantitative (40-42) and ethical aspect (43-44), hyperlinks actualization (30-33). Kappa were positives but very small which corresponds to a weak agreement between experts. The personal opinion of the expert seems to have a major impact, undermining the relevance of the criterion. Our future work is to collect results given by this evaluation grid and proposes a new scoring tool for Internet social networks assessment.

  6. Enhanced Paediatric Pharmacovigilance at the European Medicines Agency: A Novel Query Applied to Adverse Drug Reaction Reports.

    Science.gov (United States)

    Blake, Kevin V; Saint-Raymond, Agnes; Zaccaria, Cosimo; Domergue, Francois; Pelle, Benjamin; Slattery, Jim

    2016-02-01

    Databases of suspected adverse drug reactions (ADRs) are a cornerstone of pharmacovigilance. With increasing numbers of reports, additional statistical approaches are needed to better use the data. The present study was aimed at elucidating the European Medicines Agency's (EMA) use of a novel 'paediatric' query to analyse the data in its ADR database 'EudraVigilance'. The proportional reporting ratio (PRR) is a measure of disproportionality for which the underlying principle is that a drug-event pair of interest is reported more often than expected relative to an independence model. The EMA's paediatric query, based on PRRs, was applied to the data in EudraVigilance to investigate the extent to which the known association between enalapril and renal toxicity was reflected in reported ADRs comparing children with adults and with adjustment for the effect of multiplicity. The comparison of PRRs for children (14.91, 95% confidence interval [CI] 13.05-17.04) versus adults (2.66, 95% CI 2.52-2.82) confirmed a higher risk of renal ADRs with enalapril when used in children compared with all other medicines and compared with adults. The EMA's paediatric query can be used to highlight an imbalance for a drug-event pair among ADRs for a medicine when used in children and as compared with adults. Applying the query in practice can help the EMA to decide on whether stand-alone paediatric medicine development is warranted, and which, if any, further studies are necessary. Ongoing evaluation of the query is contributing to the development of new methods and guidance.

  7. Implementing a pharmacovigilance program to evaluate cutaneous adverse drug reactions in an antiretroviral access program

    Science.gov (United States)

    Mudzviti, Tinashe; Sibanda, Marvelous; Gavi, Samuel; Maponga, Charles Chiedza; Morse, Gene D.

    2012-01-01

    Background Cutaneous adverse drug reactions (cADRs) can cause significant morbidity and distress in patients especially in the HIV infected population on antiretroviral therapy. Adverse Drug Reaction monitoring and ascertaining causality in resource limited settings still remains a challenge. This study was carried out to evaluate causality and measure incidence of cADRs in HIV infected patients on highly active antiretroviral therapy. The study was also designed to test a 3-step approach in the monitoring and evaluation of ADRs in resource limited settings. Methodology A retrospective patient medical records review was carried out at the Parirenyatwa Family Care Centre, (Harare, Zimbabwe). Cases of cADRs were reported to the Medicines Control Authority of Zimbabwe (Drug regulating body in Zimbabwe) for assessment and causality classification. Results Two hundred and twenty-one patient records were randomly selected and reviewed to determine if any diagnosis of cADRs was made by clinicians. Causality assessment revealed 13.1% of cADRs which were due to an offending agent in the antiretroviral therapy against an initial incidence of 17.6% which had been determined by the physicians. Conclusions cADRs had an incidence of 13.1% within the population under study due to non nucleoside reverse transcriptase inhibitors (NNRTIs). Most reactions were due to the NNRTIs which contributed 72.4 % of all cADRs. A panel of experts from the drug regulatory authority can be used as an implementation based mechanism in ascertaining causality objectively in settings where resources are constrained. PMID:23277506

  8. Impact of the HLA-B(*)58:01 Allele and Renal Impairment on Allopurinol-Induced Cutaneous Adverse Reactions.

    Science.gov (United States)

    Ng, Chau Yee; Yeh, Yu-Ting; Wang, Chuang-Wei; Hung, Shuen-Iu; Yang, Chih-Hsun; Chang, Ya-Ching; Chang, Wan-Chun; Lin, Yu-Jr; Chang, Chee-Jen; Su, Shih-Chi; Fan, Wen-Lang; Chen, Der-Yuan; Wu, Yeong-Jian Jan; Tian, Ya-Chung; Hui, Rosaline Chung-Yee; Chung, Wen-Hung

    2016-07-01

    Allopurinol, a common drug for treating hyperuricemia, is associated with cutaneous adverse drug reactions ranging from mild maculopapular exanthema to life-threatening severe cutaneous adverse reactions, including drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis. We have previously reported that HLA-B*58:01 is strongly associated with allopurinol-induced severe cutaneous adverse reactions in Han Chinese, but the associations of the HLA-B*58:01 genotype in an allopurinol-induced hypersensitivity phenotype remain unclear. To investigate the comprehensive associations of HLA-B*58:01, we enrolled 146 patients with allopurinol-induced cutaneous adverse drug reactions (severe cutaneous adverse reactions, n = 106; maculopapular exanthema, n = 40) and 285 allopurinol-tolerant control subjects. Among these allopurinol-induced cutaneous adverse drug reactions, HLA-B*58:01 was strongly associated with severe cutaneous adverse reactions (odds ratio [OR] = 44.0; 95% confidence interval = 21.5-90.3; P = 2.6 × 10(-41)), and the association was correlated with disease severity (OR = 44.0 for severe cutaneous adverse reactions, OR = 8.5 for maculopapular exanthema). The gene dosage effect of HLA-B*58:01 also influenced the development of allopurinol-induced cutaneous adverse drug reactions (OR = 15.25 for HLA-B*58:01 heterozygotes and OR = 72.45 for homozygotes). Furthermore, coexistence of HLA-B*58:01 and renal impairment increased the risk and predictive accuracy of allopurinol-induced cutaneous adverse drug reactions (heterozygous HLA-B*58:01 and normal renal function: OR = 15.25, specificity = 82%; homozygous HLA-B*58:01 and severe renal impairment: OR = 1269.45, specificity = 100%). This HLA-B*58:01 correlation study suggests that patients with coexisting HLA-B*58:01 and renal impairment (especially estimated glomerular filtration rate < 30ml/minute/1.73 m(2)) should be cautious and avoid using

  9. The nineteenth report on survey of the adverse reaction to radiopharmaceuticals. The 22nd survey in 1996

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-03-01

    The report included cases of adverse reaction to radiopharmaceuticals and of drug defect which had occurred from April 1, 1996 to March 31, 1997. The survey was done by the questionnaire to 1,182 nuclear medicine facilities in Japan and 961 answers (81.3%) were obtained. Thirty one cases of adverse reactions were reported from 31 facilities in 1,264,865 cases to that radiopharmaceuticals had been administered and 7 cases of drug defect were reported from 7 facilities. Adverse reactions involved 8 vasovagal reactions, 14 allergic reactions and 9 others for {sup 99m}Tc-MAA (adverse reaction rate in %: 0.0025), -PYP (0.0352), -HM-PAO (0.0025), -MDP{center_dot}HMDP (0.0008), -DTPA (0.0189), -HSA (0.0086), -MIBI (0.0066), -tetrofosmin (0.0032), -MAG{sub 3} (0.0147), {sup 201}Tl-TlCl2 (0.0014), {sup 123}I-NaI capsule (0.0068), -IMP (0.0016), {sup 131}I-NaI capsule (0.0128) and -iodomethyl-norcholesterol (0.2752). Drug defects involved 1 incomplete radio-labeling, 3 broken or contaminated vials and 3 others. Relative to those hitherto, adverse reaction cases tended to be decreasing and drug defect cases clearly decreased. (K.H.)

  10. The fifteenth report on survey of the adverse reaction to radiopharmaceuticals; The 18th survey in 1992

    Energy Technology Data Exchange (ETDEWEB)

    1994-03-01

    This report deals with adverse reactions to radiopharmaceuticals occurring during the period from April 1, 1992 through March 31, 1993. Questionnaires were sent to 1,160 facilities, and 894 (77.1%) responded. Fifteen cases of adverse reactions and 8 cases of drug defects were reported from a total of 19 facilities (2.1%), giving an annual occurrence of 1.4 cases of adverse reactions and 0.8 cases of drug defects for 100,000 examinations. The incidence of adverse reactions was the highest for sodium iodohippurate injection (I-123 or I-131)(n=5), followed by Tc-99m DTPA injection (n=3), Ga-67 citrate injection (n=2), Tc-99m RBC pyrophosphate (n=2), I-131 iodomethyl norcholesterol (n=one), Tc-99m macroaggregated albumin(MAA) (n=one), and Tc-99m Sn colloid (n=one). Adverse reactions included reactions to vagus nerves (n=5), allergic reactions (n=5) and others (n=5). Radiopharmaceuticals reported as drug defects were as follows: Tc-99m generator, Tc-99m MAA, Tc-99m pyrophosphorie acid, Tc-99m hydroxymethylene diphosphonate(HMDP), Tc-99m methylene diphosphonate(MDP), Tc-99m hexamethylpropyleneamine oxime(HMPAO), and Ga-67 citrate. (N.K.).

  11. The thirteenth report on survey of the adverse reaction to radiopharmaceuticals; The 16th survey in 1990

    Energy Technology Data Exchange (ETDEWEB)

    1992-03-01

    This report deals with adverse reactions to radiopharmaceuticals occurring during the period from April 1, 1990 through March 31, 1991. Questionnaires were sent to 1,141 facilities, and 857 (75.1%) responded. Thirteen cases of adverse reactions and 15 cases of drug defects were reported from a total of 23 facilities (2.7%), giving an annual occurrence of 1.3 cases and 1.5 cases, respectively, for 100,000 examinations. Among the reported 13 adverse reactions, the highest incidence was seen for both I-131 sodium iodohippurate (n=4) injection and Tc-99m DTPA injection (n=4), followed by I-131 iodomethyl norcholesterol (n=2). Each one of the other adverse reactions was seen for Tc-99m RBC injection, Tc-99m HMDP injection, and I-123 IMP injection. Adverse reactions included reactions to the vagus nerves (n=8), allergic reactions (n=2), and others (n=3). Drug defects consisted of unfavorable distribution (n=8), destroyed or contaminated containers (n=4), unfavorable elution (n=2), and mixed foreign bodies (n=one). Radiopharmaceuticals reported as drug defects were as follows: Ga-67 citrate, Tc-99m generator, Tc-99m MAA, Tc-99m RBC, Tc-99m DMSA, Tc-99m MDP, Tc-99m HMDP, Xe-133 injection, and Tl-201 chloride. (N.K.).

  12. A prospective study of adverse drug reactions in a dermatology department.

    Science.gov (United States)

    Ganeva, Maria; Gancheva, T; Lazarova, R; Tzvetanova, Y; Hristakieva, E

    2007-03-01

    The objective of this study was to evaluate the clinical pattern and risk factors for adverse drug reactions (ADRs) in patients hospitalized in a specialized dermatology department. A prospective study was conducted in the Clinic of Dermatology and Venereology in Stara Zagora for a 5-year period. ADRs were classified by type, severity and causality. Case-causality was scored according to Naranjo et al. (1981). A total of 1041 admissions were analyzed. ADRs occurred in 147 patients. Cutaneous reactions represented the most common ADRs followed by endocrine/metabolic, cardiovascular and gastrointestinal disorders. The prevalent clinical patterns of cutaneous ADRs were exanthematous and urticarial. ADRs were almost evenly distributed as type A and type B reactions. Drug classes most frequently responsible for ADRs were glucocorticosteroids (GLCs) and antiinfective agents. The factors significantly associated with ADRs were the use of GLCs (OR 11.11; 95% CI 6.69-18.43), antiinfective agents (OR 1.48; 95% CI 1.04-2.11) and older age. Patients hospitalized in a dermatology department may develop ADRs with multiorgan clinical presentation. The most important risk factors for ADRs in this sample of patients were the use of GLCs, antiinfective agents and older age. The study establishes a specific ADR risk profile of patients with dermatological disorders in a hospital setting. Copyright 2007 Prous Science.

  13. Data-mining for detecting signals of adverse drug reactions of fluoxetine using the Korea Adverse Event Reporting System (KAERS) database.

    Science.gov (United States)

    Kim, Seonji; Park, Kyounghoon; Kim, Mi-Sook; Yang, Bo Ram; Choi, Hyun Jin; Park, Byung-Joo

    2017-10-01

    Selective serotonin reuptake inhibitors (SSRIs) have become one of the most broadly used medications in psychiatry. Fluoxetine is the first representative antidepressant SSRI drug approved by the Food and Drug Administration (FDA) in 1987. Safety information on fluoxetine use alone was less reported than its combined use with other drugs. There were no published papers on adverse drug reactions (ADRs) of fluoxetine analyzing spontaneous adverse events reports. We detected signals of the adverse drug reactions of fluoxetine by data mining using the Korea Adverse Events Reporting System (KAERS) database. We defined signals in this study by the reporting odds ratios (ROR), proportional reporting ratios (PRR), and information components (IC) indices. The KAERS database included 860,224 AE reports, among which 866 reports contained fluoxetine. We compared the labels of fluoxetine among the United States, UK, Germany, France, China, and Korea. Some of the signals, including emotional lability, myositis, spinal stenosis, paradoxical drug reaction, drug dependence, extrapyramidal disorder, adrenal insufficiency, and intracranial hemorrhage, were not labeled in the six countries. In conclusion, we identified new signals that were not known at the time of market approval. However, certain factors should be required for signal evaluation, such as clinical significance, preventability, and causality of the detected signals. Copyright © 2017 Elsevier B.V. All rights reserved.

  14. Estimating time-to-onset of adverse drug reactions from spontaneous reporting databases.

    Science.gov (United States)

    Leroy, Fanny; Dauxois, Jean-Yves; Théophile, Hélène; Haramburu, Françoise; Tubert-Bitter, Pascale

    2014-02-03

    Analyzing time-to-onset of adverse drug reactions from treatment exposure contributes to meeting pharmacovigilance objectives, i.e. identification and prevention. Post-marketing data are available from reporting systems. Times-to-onset from such databases are right-truncated because some patients who were exposed to the drug and who will eventually develop the adverse drug reaction may do it after the time of analysis and thus are not included in the data. Acknowledgment of the developments adapted to right-truncated data is not widespread and these methods have never been used in pharmacovigilance. We assess the use of appropriate methods as well as the consequences of not taking right truncation into account (naive approach) on parametric maximum likelihood estimation of time-to-onset distribution. Both approaches, naive or taking right truncation into account, were compared with a simulation study. We used twelve scenarios for the exponential distribution and twenty-four for the Weibull and log-logistic distributions. These scenarios are defined by a set of parameters: the parameters of the time-to-onset distribution, the probability of this distribution falling within an observable values interval and the sample size. An application to reported lymphoma after anti TNF- α treatment from the French pharmacovigilance is presented. The simulation study shows that the bias and the mean squared error might in some instances be unacceptably large when right truncation is not considered while the truncation-based estimator shows always better and often satisfactory performances and the gap may be large. For the real dataset, the estimated expected time-to-onset leads to a minimum difference of 58 weeks between both approaches, which is not negligible. This difference is obtained for the Weibull model, under which the estimated probability of this distribution falling within an observable values interval is not far from 1. It is necessary to take right truncation into

  15. Hypersensitivity reactions to anticancer agents: Data mining of the public version of the FDA adverse event reporting system, AERS

    Directory of Open Access Journals (Sweden)

    Sakaeda Toshiyuki

    2011-10-01

    Full Text Available Abstract Background Previously, adverse event reports (AERs submitted to the US Food and Drug Administration (FDA database were reviewed to confirm platinum agent-associated hypersensitivity reactions. The present study was performed to confirm whether the database could suggest the hypersensitivity reactions caused by anticancer agents, paclitaxel, docetaxel, procarbazine, asparaginase, teniposide, and etoposide. Methods After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving candidate agents were analyzed. The National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 was applied to evaluate the susceptibility to hypersensitivity reactions, and standardized official pharmacovigilance tools were used for quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Results Based on 1,644,220 AERs from 2004 to 2009, the signals were detected for paclitaxel-associated mild, severe, and lethal hypersensitivity reactions, and docetaxel-associated lethal reactions. However, the total number of adverse events occurring with procarbazine, asparaginase, teniposide, or etoposide was not large enough to detect signals. Conclusions The FDA's adverse event reporting system, AERS, and the data mining methods used herein are useful for confirming drug-associated adverse events, but the number of co-occurrences is an important factor in signal detection.

  16. Adverse reactions to cosmetic products and the Notification System in Health Surveillance: a survey

    Directory of Open Access Journals (Sweden)

    Gisele Huf

    2013-12-01

    Full Text Available INTRODUCTION: This paper is part of a study that investigates the quality of cosmetic products and evaluates the cosmetic surveillance system. OBJECTIVE: This study presents the results of a research that aimed to describe the point of view of the population in terms of the prevalence of Adverse Reactions (AR and information about the surveillance system. METHODS: A structured questionnaire was applied to a random sample of 200 people from the administrative staff of the Municipal Guard of Rio de Janeiro. RESULTS: 38% of the participants declared AR to some cosmetic product used in the past two years. CONCLUSION: To our knowledge, this is an unpublished study in Brazil, which presents results regarding the estimated prevalence of AR similarly to international studies.

  17. [Analysis of adverse drug reaction of gatifloxacin in Hunan province from Aug. 2003 to Jul. 2007].

    Science.gov (United States)

    Deng, Sheng; He, Yanchun; Yin, Tao; Long, Liping; Zhang, Wei

    2009-01-01

    To summarize the occurrences of adverse drug reactions (ADR) of gatifloxacin, and to guide the rational usage of antibacterial agents in clinical practice in the future. A total of 1 077 ADR patient who received gatifloxacin were retrospectively studied in Hunan province from August 2003 to July 2007. Gatifloxacin could cause multi-system and multi-organ ADRs with wide variety of clinical manifestations. Of the 1 077 ADR patients, ADR incidence rate was slightly lower in males than that in females, the age of 821 (76.23%) ADR patients were 20 approximately 59 years; 905 (84.03%) were administered intravenously; and 682 (33.07%) had severe lesions of the digestive system, followed by lesions of the skin and the appendants (490 cases, 23.76%) and the nervous system (298 cases, 14.45%). ADR caused by gatifloxacin should be monitored and reported so as to reduce or avoid ADR.

  18. Titanium Alloy Stem as a Cause for Adverse Reaction to Metal Debris after Bipolar Hemiarthroplasty

    Directory of Open Access Journals (Sweden)

    Masaaki Sakamoto

    2014-01-01

    Full Text Available A 68-year-old male with failure of bipolar hemiarthroplasty consistent with adverse reaction to metal debris (ARMD who presented with a painful cystic lesion and lower extremity swelling was encountered. However, revision surgical findings showed no apparent cause of ARMD previously described in the literature, such as corrosion at the head-neck junction and articular abrasion. Therefore, it was difficult to make a definite diagnosis of failure secondary to ARMD, which consequently led to the decision to perform two-stage revision procedure, though the stem was firmly fixed. Postoperative analysis in the retrieval tissues showed that the metal debris mainly originated from the titanium alloy stem itself. Although this is a very rare case, one should be aware that even the well-fixed femoral components themselves have the potential to be the cause of ARMD.

  19. Prevalence of adverse food reactions in 130 dogs in Italy with dermatological signs: a retrospective study.

    Science.gov (United States)

    Proverbio, D; Perego, R; Spada, E; Ferro, E

    2010-07-01

    To determine the prevalence of adverse food reactions (AFRs) in dogs with dermatological signs presented to the referral dermatological clinic of the University of Milan. The medical records of dogs with dermatological signs were reviewed. Prevalence of AFRs was calculated. Owner and clinician pruritus scores were compared. Breed, sex and age predisposition were statistically tested, as was the association between AFR and selected clinical features. The prevalence of AFRs in dogs with dermatological signs was 12% (16 of 130). AFR was diagnosed in 26% of dogs with allergic disease and 48% of those subjected to a dietary trial. There was a significant association between AFRs and early onset of clinical signs (dogs with perianal fistulas were German shepherd dogs. The prevalence of AFRs in the study population was higher than most reported values. Further studies are warranted to investigate the true prevalence of AFR and its possible association with perianal fistula and other potential markers.

  20. Detection of Adverse Reaction to Drugs in Elderly Patients through Predictive Modeling

    Directory of Open Access Journals (Sweden)

    Rafael San-Miguel Carrasco

    2016-03-01

    Full Text Available Geriatrics Medicine constitutes a clinical research field in which data analytics, particularly predictive modeling, can deliver compelling, reliable and long-lasting benefits, as well as non-intuitive clinical insights and net new knowledge. The research work described in this paper leverages predictive modeling to uncover new insights related to adverse reaction to drugs in elderly patients. The differentiation factor that sets this research exercise apart from traditional clinical research is the fact that it was not designed by formulating a particular hypothesis to be validated. Instead, it was data-centric, with data being mined to discover relationships or correlations among variables. Regression techniques were systematically applied to data through multiple iterations and under different configurations. The obtained results after the process was completed are explained and discussed next.

  1. Adverse drug reactions to self-medication: a study in a pharmacovigilance database.

    Science.gov (United States)

    Berreni, Aurélia; Montastruc, François; Bondon-Guitton, Emmanuelle; Rousseau, Vanessa; Abadie, Delphine; Durrieu, Geneviève; Chebane, Leila; Giroud, Jean-Paul; Bagheri, Haleh; Montastruc, Jean-Louis

    2015-10-01

    Although self-medication is widely developed, there are few detailed data about its adverse drug reactions (ADRs). This study investigated the main characteristics of ADRs with self-medication recorded in the Midi-Pyrénées PharmacoVigilance between 2008 and 2014. Self-medication included first OTC drugs and second formerly prescribed drugs later used without medical advice (reuse of previously prescribed drugs). Among the 12 365 notifications recorded, 160 (1.3%) were related to SM with 186 drugs. Around three-forth of the ADRs were 'serious'. Mean age was 48.8 years with 56.3% females. The most frequent ADRs were gastrointestinal and neuropsychiatric and main drug classes involved NSAIDs, analgesics, and benzodiazepines. Phytotherapy-homeopathy accounted for 9.1% of drugs. © 2015 Société Française de Pharmacologie et de Thérapeutique.

  2. Renal function, nephrogenic systemic fibrosis and other adverse reactions associated with gadolinium-based contrast media.

    Science.gov (United States)

    Canga, Ana; Kislikova, Maria; Martínez-Gálvez, María; Arias, Mercedes; Fraga-Rivas, Patricia; Poyatos, Cecilio; de Francisco, Angel L M

    2014-01-01

    Nephrogenic systemic fibrosis is a fibrosing disorder that affects patients with impaired renal function and is associated with the administration of gadolinium-based contrast media used in MRI. Despite being in a group of drugs that were considered safe, report about this potentially serious adverse reaction was a turning point in the administration guidelines of these contrast media. There has been an attempt to establish safety parameters to identify patients with risk factors of renal failure. The close pharmacovigilance and strict observation of current regulations, with special attention being paid to the value of glomerular filtration, have reduced the published cases involving the use of gadolinium-based contrast media. In a meeting between radiologists and nephrologists we reviewed the most relevant aspects currently and recommendations for its prevention.

  3. Automated Summarization of Publications Associated with Adverse Drug Reactions from PubMed.

    Science.gov (United States)

    Finkelstein, Joseph; Chen, Qinlang; Adams, Hayden; Friedman, Carol

    2016-01-01

    Academic literature provides rich and up-to-date information concerning adverse drug reactions (ADR), but it is time consuming and labor intensive for physicians to obtain information of ADRs from academic literature because they would have to generate queries, review retrieved articles and summarize the results. In this study, a method is developed to automatically detect and summarize ADRs from journal articles, rank them and present them to physicians in a user-friendly interface. The method studied ADRs for 6 drugs and returned on average 4.8 ADRs that were correct. The results demonstrated this method was feasible and effective. This method can be applied in clinical practice for assisting physicians to efficiently obtain information about ADRs associated with specific drugs. Automated summarization of ADR information from recent publications may facilitate translation of academic research into actionable information at point of care.

  4. Perception of the risk of adverse reactions to analgesics: differences between medical students and residents

    Directory of Open Access Journals (Sweden)

    Sandra Castillo-Guzman

    2016-07-01

    Full Text Available Background. Medications are not exempt from adverse drug reactions (ADR and how the physician perceives the risk of prescription drugs could influence their availability to report ADR and their prescription behavior. Methods. We assess the perception of risk and the perception of ADR associated with COX2-Inbitors, paracetamol, NSAIDs, and morphine in medical students and residents of northeast of Mexico. Results. The analgesic with the highest risk perception in both group of students was morphine, while the drug with the least risk perceived was paracetamol. Addiction and gastrointestinal bleeding were the ADR with the highest score for morphine and NSAIDs respectively. Discussion. Our findings show that medical students give higher risk scores than residents toward risk due to analgesics. Continuing training and informing physicians about ADRs is necessary since the lack of training is known to induce inadequate use of drugs.

  5. Observation on the adverse reactions of different concentrations of povidone-iodine applied before cataract surgery

    Directory of Open Access Journals (Sweden)

    Shan-Jun Wu

    2013-12-01

    Full Text Available AIM: To evaluate the efficiency and safety of 50g/L povidone-iodine solution in preventing postoperative endophthalmitis through comparing the incidence of postoperative endophthalmitis and adverse reactions after conjunctival sac washing with povidone-iodine of different concentrations.METHODS: Totally 500 cataract patients were divided into 50g/L povidone-iodine group and 25g/L povidone-iodine group. All the operated eyes were observed during and after surgery.The patients' subjective discomfort was inquired and their signs of eyes were recorded. RESULTS: The eye irritation of 50g/L povidone-iodine group was more significant than 25g/L povidone-iodine group. No significant difference in the corneal epithelial loss and endophthalmitis was observed between two groups.CONCLUSION:Conjunctival sac washing with 50g/L povidone-iodine is an effective and safe measure to prevent endophthalmitis after cataract surgery.

  6. Adverse drug reactions of systemic antihistamines in children in the Netherlands.

    Science.gov (United States)

    de Vries, Tjalling W; van Hunsel, Florence

    2016-10-01

    Antihistamines are used for the treatment of allergic rhinitis, allergic conjunctivitis, chronic spontaneous urticaria and atopic eczema. To study the reports of adverse drug reactions (ADRs) in children using antihistamines to provide prescribers with an overview of the possible toxicity. We studied ADRs in children reported to the Netherlands Pharmacovigilance Centre Lareb in the years 1991-2014, assessed the Naranjo score and, when possible, computed the reporting OR. Serious ADRs included one death (malignant neuroleptic syndrome), cardiac arrhythmia (one case) and convulsions (three cases). Skin eruptions, headache and somnolence were the most frequently reported ADRs. Aggression and agitation were also reported. Toxicity can occur with second-generation antihistamines. The main toxicity relates to skin eruptions and central nervous system problems. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  7. A possible role for cysteinyl-leukotrienes in non-ionic contrast media induced adverse reactions

    Energy Technology Data Exchange (ETDEWEB)

    Boehm, Ingrid [Department of Radiology, University of Bonn, Sigmund Freud Strasse 25, 53105 Bonn (Germany)]. E-mail: i.boehm@uni-bonn.de; Speck, Ulrich [Department of Radiology, Humboldt University (Charite) of Berlin (Germany); Schild, Hans [Department of Radiology, University of Bonn, Sigmund Freud Strasse 25, 53105 Bonn (Germany)

    2005-09-01

    Purpose: To test whether mono- or dimeric X-ray contrast media (CM) may induce the de novo production of cysteinyl-leukotriens (cys-LT), that could contribute to allergic/allergy-like side effects. Materials and methods: Leukocytes from 39 patients receiving iopromide or iotrolan for routine CT-examination were analyzed for the production of cys-LT. Histamine levels were analyzed in plasma specimens. One patient with a positive history of a previous CM-reaction did not receive CM-injection. Results: Three patients of the iopromide and five of the iotrolan group showed adverse reactions. Reactors had increased cys-LT values in samples obtained before CM-injection induced by the positive control (anti-Fc{epsilon}RI antibodies) (6763.7 pg/ml {+-} 1367.3 versus 2299.8 pg/ml {+-} 399.2; p < 0.007). Patients with versus without CM-reaction did not differ significantly with respect to their histamine values before CM-administeration. In vitro iopromide (p < 0.0002) and iotrolan (p < 0.0008) induced significant cys-LT production as compared to IL-3 stimulation. In vivo both CM induced a significant increase 6 h after CM administration (p < 0.05). Conclusion: Our findings suggest that both CM seem to induce cys-LT production. As to whether the observed increased values in pre-dose samples of patients with as compared to those without reactions could contribute to identify high risk patients should be investigated in larger patient groups in future.

  8. Days lost due to disability of diclofenac-induced adverse drug reactions

    Directory of Open Access Journals (Sweden)

    Thomas D

    2012-03-01

    Full Text Available Disability Adjusted Life Years (DALY is a widely used measure to quantify the burden of diseases or illness. DALYs for a disease is calculated as the sum of the Years of Life Lost (YLL due to premature mortality in the population and the equivalent healthy Years Lost due to Disability (YLD. The only difference from the YLD and Days Lost due to Disability (DLD calculation is that instead of considering the duration of Adverse Drug Reaction (ADR in years, it is calculated in days. Objective: DLD was measured for diclofenac tablets to prepare the ADR profile.Methods: The study was done on the patients (18-65 years old attending the community pharmacy at Kasaragod district, South India, with prescription of diclofenac tablets. Patients reported ADRs on their next visit to the pharmacy or they had called to the provided phone number and reported it. Disability Weight (DW was calculated in an analogue scale from 0-1. Zero represent complete health and 1 represent death or equivalent condition. DW was multiplied with occurrence and duration of ADRs in days.Results: About 943 patients received diclofenac tablets in 1000 prescriptions were successfully followed up for possible, probable and definite ADRs. A total of 561 reactions reported in 2010 for diclofenac tablet in the study population. There were 34 different types of ADRs under 12 physiological systems/organs. Most common reactions were on gastrointestinal (GI system (48%, followed by skin (14%, Central Nervous System (10%, renal (7%, and cardiovascular (7%. Abdominal pain, cramps or flatulence was the highest occurring GI ADR (107, followed by 43 rashes, 42 nausea/vomiting, 37 indigestion, 34 peptic ulcers, 31 edema etc. DLD for peptic ulcer was considerably high (0.078 per 1000 of the study population on diclofenac. The most damaging ADR were peptic ulcer with or without perforation, followed by rash 0.036 DLD and edema 0.027 DLD. There was considerable DLD by acute renal failure (0.012 Steven

  9. Comorbidities and concurrent medications increasing the risk of adverse drug reactions: prevalence in French benzodiazepine users.

    Science.gov (United States)

    Bénard-Laribière, Anne; Noize, Pernelle; Pambrun, Elodie; Bazin, Fabienne; Verdoux, Hélène; Tournier, Marie; Bégaud, Bernard; Pariente, Antoine

    2016-07-01

    To estimate benzodiazepine prevalence of use and to quantify, in benzodiazepine users, the prevalence of comorbidities and concurrent medications increasing the risk of adverse drug reactions (ADRs). Cross-sectional study performed using data from the French national healthcare insurance system. The prevalence of use was estimated by considering as users, patients who had at least one benzodiazepine reimbursement during the year 2013. Patients at increased risk for benzodiazepine ADRs were those who had (i) drug-drug interactions at risk for central nervous system and respiratory depression and (ii) comorbidities at risk for adverse respiratory effects, or for falls or fractures. Overall, the prevalence of benzodiazepine use in 2013 was estimated to be 13.8 %; it was higher among women and increased with age. This prevalence was 10.6 % for anxiolytic benzodiazepines, and 6.1 % for hypnotic benzodiazepines. Approximately half of the benzodiazepine users (48.1 %) were at increased risk for benzodiazepine ADRs; this proportion increased with age. Drug-drug interactions represented the most prevalent condition (39.3 % of benzodiazepine users). The drugs most frequently involved were opioids: analgesics (15.9 %) and antitussives (6.8 %). Overall, 11.3 % of benzodiazepine users had comorbidities at increased risk for adverse respiratory effects (13.9 % in those aged 65-79), and 7.0 % comorbidities at increased risk for falls or fractures (13.4 % in those aged ≥80). This study found that benzodiazepine use remained high in France, and that roughly half of the users presented with comorbidities and concurrent medications increasing the risk of ADRs. These findings are of concern, given that benzodiazepines are frequently used, and especially among the elderly.

  10. Does an allergy to fish pre-empt an adverse protamine reaction? A case report and a literature review.

    LENUS (Irish Health Repository)

    Collins, C

    2008-11-01

    The operating theatre exposes patients to myriad potential agents which could result in a life-threatening anaphylactic reaction. Anaesthetic drugs, blood products, and latex are only some of the possible allergens. Reactions are deemed to be anaphylactic when immediate sensitivity is combined with cardiovascular collapse. A patient who had a known allergy to shellfish presented for first time cardiopulmonary bypass. The perfusion team were concerned that there was a realistic possibility that an adverse reaction to protamine could occur. Anaphylactic reactions to protamine in patients allergic to fish have been reported. The anaesthetic team were informed and the necessary precautions taken. We report on the outcome for our patient and also discuss other risk factors and the types of reactions that can result when an adverse reaction to protamine occurs.

  11. Abnormal splicing of NEDD4 in myotonic dystrophy type 2: possible link to statin adverse reactions.

    Science.gov (United States)

    Screen, Mark; Jonson, Per Harald; Raheem, Olayinka; Palmio, Johanna; Laaksonen, Reijo; Lehtimäki, Terho; Sirito, Mario; Krahe, Ralf; Hackman, Peter; Udd, Bjarne

    2014-08-01

    Myotonic dystrophy type 2 (DM2) is a multisystemic disorder caused by a (CCTG)n repeat expansion in intron 1 of CNBP. Transcription of the repeats causes a toxic RNA gain of function involving their accumulation in ribonuclear foci. This leads to sequestration of splicing factors and alters pre-mRNA splicing in a range of downstream effector genes, which is thought to contribute to the diverse DM2 clinical features. Hyperlipidemia is frequent in DM2 patients, but the treatment is problematic because of an increased risk of statin-induced adverse reactions. Hypothesizing that shared pathways lead to the increased risk, we compared the skeletal muscle expression profiles of DM2 patients and controls with patients with hyperlipidemia on statin therapy. Neural precursor cell expressed, developmentally downregulated-4 (NEDD4), an ubiquitin ligase, was one of the dysregulated genes identified in DM2 patients and patients with statin-treated hyperlipidemia. In DM2 muscle, NEDD4 mRNA was abnormally spliced, leading to aberrant NEDD4 proteins. NEDD4 was down-regulated in persons taking statins, and simvastatin treatment of C2C12 cells suppressed NEDD4 transcription. Phosphatase and tensin homologue (PTEN), an established NEDD4 target, was increased and accumulated in highly atrophic DM2 muscle fibers. PTEN ubiquitination was reduced in DM2 myofibers, suggesting that the NEDD4-PTEN pathway is dysregulated in DM2 skeletal muscle. Thus, this pathway may contribute to the increased risk of statin-adverse reactions in patients with DM2. Copyright © 2014 American Society for Investigative Pathology. Published by Elsevier Inc. All rights reserved.

  12. Knowledge of adverse drug reaction reporting in first year postgraduate doctors in a medical college

    Directory of Open Access Journals (Sweden)

    Upadhyaya P

    2012-06-01

    Full Text Available Prerna Upadhyaya,1 Vikas Seth,2 Vijay V Moghe,1 Monika Sharma,1 Mushtaq Ahmed11Department of Pharmacology, Mahatma Gandhi Medical College, Sitapura, Jaipur, Rajasthan, 2Department of Pharmacology, Hind Institute of Medical Sciences, Safedabad, Barabanki, Lucknow, Uttar Pradesh, IndiaIntroduction: Poor reporting of adverse drug reactions (ADRs by doctors is a major hindrance to successful pharmacovigilance. The present study was designed to assess first-year residents’ knowledge of ADR reporting.Methods: First-year postgraduate doctors at a private medical college completed a structured questionnaire. The responses were analyzed by nonparametric methods.Results: All doctors were aware of the term “adverse drug reactions.” Fifty percent of the doctors reported being taught about ADR reporting during their undergraduate teaching, and 50% had witnessed ADRs in their internship training. Ten percent of patients suffering an ADR observed and reported by doctors required prolonged hospitalization for treatment as a result. Only 40% of interns reported the ADRs that they observed, while 60% did not report them. Twenty-eight percent reported ADRs to the head of the department, 8% to an ADR monitoring committee, and 4% to the pharmacovigilance center. Eighty-six percent of the doctors surveyed felt that a good knowledge of undergraduate clinical pharmacology therapeutics would have improved the level of ADR reporting.Conclusion: The knowledge of first-year doctors regarding ADR reporting is quite poor. There is a dire need to incorporate ADR reporting into undergraduate teaching, and to reinforce this during internships and periodically thereafter.Keywords: ADR reporting, pharmacovigilance, first-year postgraduate doctors

  13. Morphological Pattern of Cutaneous Adverse Drug Reactions due to Antiepileptic Drugs in Eastern India

    Science.gov (United States)

    Singh, Punit Kumar; Kumar, Dharmendra; Kumar, Prashant

    2015-01-01

    Introduction: Cutaneous manifestations of adverse drug reactions are a common occurrence and need to be differentiated from other causes of similar manifestations. Antiepileptic drugs (AED) usually are responsible for severe cutaneous adverse drug reactions (CADR) like Stevens-Johnson Syndrome/Toxic epidermal necrolysis (SJS/TEN) and drug rash with eosinophillia and systemic symptoms (DRESS). There is paucity of published research regarding morphological pattern of CADR due to various antiepileptic drugs AED. Objective: To study the morphological patterns of CADR due to AED and common anticonvulsant drugs implicated particularly in severe CADR such as SJS/TEN and DRESS in a tertiary care teaching hospital in eastern India. Materials and Methods: A prospective, observational study was conducted over a period of 4 years from August 2009 to July 2013 after the approval of the Institutional Ethics Committee using self-reporting method for selection of cases. Settings: All patients with CADR after AED consumption for various conditions presenting to the Dermatology outpatient department (OPD) and Pediatric OPD and Indoor patients of a tertiary care teaching hospital located in Rohtas district of Bihar were included in this study. Results: During the study period, 64 cases of severe CADRs were included in this study. Out of 64 patients, 28 were male and 36 were female with mean age 36.1 years (range 6 years to 72 years). Most common AED implicated for CADR was Phenytoin. Maculopapular rash was the most common cutaneous manifestation of ADRs (42.85%). Serious CADR like TEN and SSJS were more likely in patients prescribed Phenytoin and Carbemazepine simultaneously. Conclusion: CADRs are a common occurrence and awareness about the same is essential for diagnosis and prevention. This study identified combined use of phenytoin and carbamezepine as a most important risk factor for serious CADR like SJS and TEN. PMID:25738068

  14. [Incidence rate of adverse reaction/event by Qingkailing injection: a Meta-analysis of single rate].

    Science.gov (United States)

    Ai, Chun-ling; Xie, Yan-ming; Li, Ming-quan; Wang, Lian-xin; Liao, Xing

    2015-12-01

    To systematically review the incidence rate of adverse drug reaction/event by Qingkailing injection. Such databases as the PubMed, EMbase, the Cochrane library, CNKI, VIP WanFang data and CBM were searched by computer from foundation to July 30, 2015. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data and cross check data. Then, Meta-analysis was performed by using the R 3.2.0 software, subgroup sensitivity analysis was performed based on age, mode of medicine, observation time and research quality. Sixty-three studies involving 9,793 patients with Qingkailing injection were included, 367 cases of adverse reactions/events were reported in total. The incidence rate of adverse reaction in skin and mucosa group was 2% [95% CI (0.02; 0.03)]; the digestive system adverse reaction was 6% [95% CI(0.05; 0.07); the injection site adverse reaction was 4% [95% CI (0.02; 0.07)]. In the digestive system as the main types of adverse reactions/events, incidence of children and adults were 4.6% [0.021 1; 0.097 7] and 6.9% [0.053 5; 0.089 8], respectively. Adverse reactions to skin and mucous membrane damage as the main performance/event type, the observation time > 7 days and ≤ 7 days incidence of 3% [0.012 9; 0.068 3] and 1.9% [0.007 8; 0.046 1], respectively. Subgroup analysis showed that different types of adverse reactions, combination in the incidence of adverse reactions/events were higher than that of single drug, the difference was statistically significant (P reactions occur, and clinical rational drug use, such as combination, age and other fators, and the influence factors vary in different populations. Therefore, clinical doctors for children and the elderly use special care was required for a clear and open spirit injection, the implementation of individualized medication.

  15. Adverse drug reaction monitoring: support for pharmacovigilance at a tertiary care hospital in Northern Brazil

    Science.gov (United States)

    2013-01-01

    Background Adverse drug reactions (ADRs) are recognised as a common cause of hospital admissions, and they constitute a significant economic burden for hospitals. Hospital-based ADR monitoring and reporting programmes aim to identify and quantify the risks associated with the use of drugs provided in a hospital setting. This information may be useful for identifying and minimising preventable ADRs and may enhance the ability of prescribers to manage ADRs more effectively. The main objectives of this study were to evaluate ADRs that occurred during inpatient stays at the Hospital Geral de Palmas (HGP) in Tocantins, Brazil, and to facilitate the development of a pharmacovigilance service. Methods A prospective study was conducted at HGP over a period of 8 months, from January 2009 to August 2009. This observational, cross-sectional, descriptive study was based on an analysis of medical records. Several parameters were utilised in the data evaluation, including patient demographics, drug and reaction characteristics, and reaction outcomes. The reaction severity and predisposing factors were also assessed. Results The overall incidence of ADRs in the patient population was 3.1%, and gender was not found to be a risk factor. The highest ADR rate (75.8%) was found in the adult age group 15 to 50 years, and the lowest ADR rate was found in children aged 3 to 13 years (7.4%). Because of the high frequency of ADRs in orthopaedic (25%), general medicine (22%), and oncology (16%) patients, improved control of the drugs used in these specialties is required. Additionally, the nurse team (52.7%) registered the most ADRs in medical records, most likely due to the job responsibilities of nurses. As expected, the most noticeable ADRs occurred in skin tissues, with such ADRs are more obvious to medical staff, with rashes being the most common reactions. Metamizole, tramadol, and vancomycin were responsible for 21, 11.6, and 8.4% of ADRs, respectively. The majority of ADRs had

  16. Syntax Score and Major Adverse Cardiac Events in Patients with Suspected Coronary Artery Disease: Results from a Cohort Study in a University-Affiliated Hospital in Southern Brazil.

    Science.gov (United States)

    Fuchs, Felipe C; Ribeiro, Jorge P; Fuchs, Flávio D; Wainstein, Marco V; Bergoli, Luis C; Wainstein, Rodrigo V; Zen, Vanessa; Kerkhoff, Alessandra C; Moreira, Leila B; Fuchs, Sandra C

    2016-09-01

    The importance of coronary anatomy in predicting cardiovascular events is well known. The use of traditional anatomical scores in routine angiography, however, has not been incorporated to clinical practice. SYNTAX score (SXscore) is a scoring system that estimates the anatomical extent of coronary artery disease (CAD). Its ability to predict outcomes based on a baseline diagnostic angiography has not been tested to date. To evaluate the performance of the SXscore in predicting major adverse cardiac events (MACE) in patients referred for diagnostic angiography. Prospective cohort of 895 patients with suspected CAD referred for elective diagnostic coronary angiography from 2008 to 2011, at a university-affiliated hospital in Brazil. They had their SXscores calculated and were stratified in three categories: no significant CAD (n = 495), SXscoreLOW-INTERMEDIATE: anatomia coronariana na predição de eventos cardiovasculares é bem conhecida. O uso de escores anatômicos tradicionais na cineangiocoronariografia de rotina, entretanto, não foi incorporado à prática clínica. O SYNTAX escore (SXescore) é um sistema de escore que estima a extensão anatômica da doença arterial coronariana (DAC). Sua capacidade para predizer desfechos com base na cineangiocoronariografia diagnóstica de base ainda não foi testada. Avaliar o desempenho do SXescore para predizer eventos cardíacos adversos maiores (MACE) em pacientes encaminhados para cineangiocoronariografia diagnóstica. Coorte prospectiva de 895 pacientes com suspeita de DAC encaminhados para cineangiocoronariografia diagnóstica eletiva de 2008 a 2011, em hospital universitário no Brasil. Os pacientes tiveram seus SXescores calculados e foram estratificados em três categorias: 'sem DAC significativa' (n = 495); SXescoreBAIXO-INTERMEDIÁRIO: < 23 (n = 346); e SXescoreALTO: ≥ 23 (n = 54). O desfecho primário foi composto de morte cardíaca, infarto do miocárdio e revascularização tardia. Os desfechos secund

  17. [Adverse drug reactions in pediatrics: Experience of a regional pharmacovigilance center].

    Science.gov (United States)

    Saint-Martin, Caroline; Kanagaratnam, Lukshe; de Boissieu, Paul; Azzouz, Brahim; Abou Taam, Malak; Trenque, Thierry

    2016-10-01

    To describe the adverse drug reactions (ADR) and the drugs involved in pediatrics. An observational study on all ADR notifications recorded in the French pharmacovigilance database by the Regional Pharmacovigilance Center of Champagne-Ardenne between 1 January 1985 and 31 December 2014 involving children from 0 to 17 years inclusive was performed. For all notifications, we studied the patient and the ADR characteristics. During the study period, 632 notifications were collected. The most frequently reported ATC (anatomical, therapeutic and chemical) classes were vaccines (15.9%), antineoplastics (12%) and antibiotics (11.1%). Forty-six percent of the notifications were serious. For serious ADRs, the most involved drugs were paracetamol, asparaginase and ibuprofen. Skin reactions were the most often reported ADRs. The most common lowest level terms (LLT) were urticaria (4.9%), hypersensitivity (4.1%), fever (2.9%) and vomiting (2.8%). ADR reporting to the pharmacovigilance system, in particular pediatric ADRs, should be encouraged. Information on the use of medicinal products, especially on self-medication use, need to be improve. Copyright © 2016 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  18. Montelukast-induced adverse drug reactions: a review of case reports in the literature.

    Science.gov (United States)

    Calapai, Gioacchino; Casciaro, Marco; Miroddi, Marco; Calapai, Fabrizio; Navarra, Michele; Gangemi, Sebastiano

    2014-01-01

    Montelukast, a leucotriene receptor antagonist, binds the cysteinyl leucotriene type 1 receptor. Montelukast is commonly prescribed to asthma patients as add-on therapy to inhaled corticosteroids. Several clinical trials emphasized that montelukast can be considered a safe drug. However, recent evidence reconsidered the benefit/risk ratio of the use of montelukast for both paediatric and adult patients. The present review analyzed the previous published case reports regarding montelukast-induced adverse drug reactions (ADRs). They included agitation, anxiety, depression, sleep disturbance, hallucinations, suicidal thinking and suicidality, tremor, dizziness, drowsiness, neuropathies and seizures. The immune system can be involved, in particular, cases of Churg-Strauss syndrome have been published. Furthermore, it can induce hypersensitivity reactions, including anaphylaxis and eosinophilic infiltration. In addition, hepatobiliary, pancreatic and uropoietic disorders have been observed. Some of these cases are characterized by severe prognosis (i.e. neurological deficit and fatal hepatotoxicity). Key Message: The use of montelukast can be burdened by several ADRs, of which physicians should be aware in their clinical practice. A better understanding of the mechanisms causing ADRs after using montelukast could help researchers and clinicians in defining a risk-reduction strategy aimed to lessen montelukast toxicity. More accurate epidemiological studies, in order to discover risk factors favouring montelukast-associated ADRs, are demanded. © 2014 S. Karger AG, Basel.

  19. Experiences from consumer reports on psychiatric adverse drug reactions with antidepressant medication: a qualitative study of reports to a consumer association.

    Science.gov (United States)

    Vilhelmsson, Andreas; Svensson, Tommy; Meeuwisse, Anna; Carlsten, Anders

    2012-12-23

    The new European pharmacovigilance legislation has been suggested as marking the beginning of a new chapter in drug safety, making patients an important part of pharmacovigilance. In Sweden since 2008 it has been possible for consumers to report adverse drug reactions (ADRs) to the Medical Products Agency (MPA), and these reports are now understood as an increasingly valuable contribution in the monitoring of safety aspects in medicines. Already in 2002 it was possible to report experiences with medicines to the non-profit and independent organization Consumer Association for Medicines and Health (KILEN) through a web-based report form with an opportunity to describe ADR experiences in free text comments. The aim of this study was to qualitatively analyze the free text comments appended to consumer reports on antidepressant medication. All reports of suspected adverse reactions regarding antidepressant medications submitted from January 2002 to April 2009 to KILEN's Internet-based reporting system in Sweden were analyzed according to reported narrative experience(s). Content analysis was used to interpret the content of 181 reports with free text comments. Three main categories emerged from the analyzed data material: (1) Experiences of drug treatment with subcategories (a) Severe psychiatric adverse reactions, and (b) Discontinuation symptoms; (2) Lack of communication and (3) Trust and distrust. A majority of the reports to KILEN were from patients experiencing symptoms of mental disturbances (sometimes severe) affecting them in many different ways, especially during discontinuation. Several report included narratives of patients not receiving information of potential ADRs from their doctor, but also that there were no follow-ups of the treatment. Trust was highlighted as especially important and some patients reported losing confidence in their doctor when they were not believed about the suspected ADRs they experienced, making them attempt to discontinue their

  20. Identification of a Syndrome Class of Neuropsychiatric Adverse Reactions to Mefloquine from Latent Class Modeling of FDA Adverse Event Reporting System Data.

    Science.gov (United States)

    Nevin, Remington L; Leoutsakos, Jeannie-Marie

    2017-03-01

    Although mefloquine use is known to be associated with a risk of severe neuropsychiatric adverse reactions that are often preceded by prodromal symptoms, specific combinations of neurologic or psychiatric reactions associated with mefloquine use are not well described in the literature. This study sought to identify a distinct neuropsychiatric syndrome class associated with mefloquine use in reports of adverse events. Latent class modeling of US Food and Drug Administration Adverse Event Reporting System (FAERS) data was performed using indicators defined by the Medical Dictionary for Regulatory Activities neurologic and psychiatric high-level group terms, in a study dataset of FAERS reports (n = 5332) of reactions to common antimalarial drugs. A distinct neuropsychiatric syndrome class was identified that was strongly and significantly associated with reports of mefloquine use (odds ratio = 3.92, 95% confidence interval 2.91-5.28), defined by a very high probability of symptoms of deliria (82.7%) including confusion and disorientation, and a moderate probability of other severe psychiatric and neurologic symptoms including dementia and amnesia (18.6%) and seizures (18.1%). The syndrome class was also associated with symptoms that are considered prodromal including anxiety, depression, sleep disturbance, and abnormal dreams, and neurological symptoms such as dizziness, vertigo, and paresthesias. This study confirms in FAERS reports the existence of a severe mefloquine neuropsychiatric syndrome class associated with common symptoms that may be considered prodromal. Clinical identification of the characteristic symptoms of this syndrome class may aid in improving case finding in pharmacovigilance studies of more serious adverse reactions to the drug.

  1. The influence of adverse reactions, subjective distress, and anxiety on retention of first-time blood donors.

    Science.gov (United States)

    van Dongen, Anne; Abraham, Charles; Ruiter, Robert A C; Veldhuizen, Ingrid J T

    2013-02-01

    This study investigated the effects of adverse events (i.e., needle reactions, fatigue, and vasovagal reactions) and feelings of distress and anxiety on retention of first-time blood donors. All effects were explored separately for men and women. First-time blood donors (n = 2438) received a questionnaire, asking them about their experience of adverse events, subjective distress, and anxiety at their first donation. Provision of a second donation was checked approximately 18 months later. After exclusion of nonresponders and donors who did not experience an adverse event, 1278 first-time donors were included in the logistic regression analyses. Nine percent of donors who experienced an adverse event at their first donation did not return for a second donation. Vasovagal reactions decreased retention in both males and females (men-odds ratio [OR], 0.45; 95% CI, 0.23-0.89; women-OR, 0.71; 95% CI, 0.51-0.98). Fatigue decreased retention in males only (OR, 0.62; 95% CI, 0.42-0.91), and subjective distress decreased retention in females only (OR, 0.77; 95% CI, 0.65-0.92). In addition to decreasing vasovagal reactions, retention interventions could productively target coping with fatigue and reducing subjective distress after adverse reactions. © 2012 American Association of Blood Banks.

  2. The Role of ARV Associated Adverse Drug Reactions in Influencing Adherence Among HIV-Infected Individuals: A Systematic Review and Qualitative Meta-Synthesis.

    Science.gov (United States)

    Li, Haochu; Marley, Gifty; Ma, Wei; Wei, Chongyi; Lackey, Mellanye; Ma, Qingyan; Renaud, Françoise; Vitoria, Marco; Beanland, Rachel; Doherty, Meg; Tucker, Joseph D

    2017-02-01

    Poor adherence remains a major barrier to achieving the clinical and public health benefits of antiretroviral drugs (ARVs). A systematic review and qualitative meta-synthesis was conduct to evaluate how ARV adverse drug reactions may influence ARV adherence. Thirty-nine articles were identified, and 33 reported that ARV adverse drug reactions decreased adherence and six studies found no influence. Visually noticeable adverse drug reactions and psychological adverse reactions were reported as more likely to cause non-adherence compared to other adverse drug reactions. Six studies reported a range of adverse reactions associated with EFV-containing regimens contributing to decreased adherence. Informing HIV-infected individuals about ARV adverse drug reactions prior to initiation, counselling about coping mechanisms, and experiencing the effectiveness of ARVs on wellbeing may improve ARV adherence.

  3. The eleventh report on survey of the adverse reaction to radiopharmaceuticals; The 14th survey in 1988

    Energy Technology Data Exchange (ETDEWEB)

    1991-03-01

    This report deals with adverse reactions to radiopharmaceuticals occurring during the period from April 1, 1988 through March 31, 1989. Qestionnaires were sent to 1,110 facilities, and 748 (67.4%) responded. Twenty one cases of adverse reactions and 13 cases of drug defect were reported from a total of 24 facilities (3.2%), giving an annual occurrence of 2.6 cases and 1.6 cases, respectively, for 100,000 examinations. The incidence of adverse reactions was the highest for I-131-6{beta}-iodomethyl-19-norcholesterol (n=254), followed by I-131 sodium iodide capsule (n=29), Tc-99m PMT injection (n=16), Tc-99m DTPA (n=12), I-131 sodium iodohippurate (n=12), Tc-99m pertechnetate (n=3), Tc-99m MDP injection (n=2), Tc-99m phytate (n=2), and Ga-67 citrate injection(n=one). Adverse reactions included reactions to the vagus nerves (n=7), allergic reactions (n=3), and others (n=11). Radiopharmaceuticals reported as drug defects were as follows: Tc-99m HMDP, Tc-99m MDP, Tc-99m PMT, Tc-99m pyrophosphate, and Tc-99m generator. (N.K.).

  4. Pharmacodynamic genetic polymorphisms affect adverse drug reactions of haloperidol in patients with alcohol-use disorder

    Directory of Open Access Journals (Sweden)

    Zastrozhin MS

    2017-07-01

    Full Text Available Mikhail Sergeevich Zastrozhin,1,2 Vadim Markovich Brodyansky,3 Valentin Yurievich Skryabin,4 Elena Anatolievna Grishina,5 Dmitry Vladimirovich Ivashchenko,5 Kristina Anatolievna Ryzhikova,5 Ludmila Mikhaylovna Savchenko,1 Alexander Olegovich Kibitov,3 Evgeny Alekseevich Bryun,1,4 Dmitry Alekseevich Sychev6 1Department of Addictology, Russian Medical Academy of Continuous Professional Education of the Ministry of Health of the Russian Federation, Moscow, Russia; 2Moscow Research and Practical Centre on Addictions of the Moscow Department of Healthcare, Center for the Prevention of Dependent Behavior, Moscow, Russia; 3Federal Medical Research Centre of Psychiatry and Addictology, Laboratory of Molecular Genetics, Moscow, Russia; 4Moscow Research and Practical Centre on Addictions of the Moscow Department of Healthcare, Department of Addictology, Moscow, Russia; 5Russian Medical Academy of Continuous Professional Education of the Ministry of Health of the Russian Federation, Research Centre, Moscow, Russia; 6Russian Medical Academy of Continuous Professional Education of the Ministry of Health of the Russian Federation, Department of Clinical Pharmacology and Therapy, Moscow, Russia Background: Antipsychotic action of haloperidol is due to blockade of D2 receptors in the mesolimbic dopamine pathway, while the adverse drug reactions are associated with striatal D2 receptor blockade. Contradictory data concerning the effects of genetic polymorphisms of genes encoding these receptors and associated structures (catechol-O-methyltransferase [COMT], glycine transporter and gene encoding the density of D2 receptors on the neuronal membrane are described.Objective: The objectives of this study were to evaluate the correlation between DRD2, SLC6A3 (DAT and COMT genetic polymorphisms and to investigate their effect on the development of adverse drug reactions in patients with alcohol-use disorder who received haloperidol.Patients and methods: The study

  5. Adverse drug reactions and drug–drug interactions with over-the-counter NSAIDs

    Directory of Open Access Journals (Sweden)

    Moore N

    2015-07-01

    Full Text Available Nicholas Moore,1 Charles Pollack,2 Paul Butkerait2 1Department of Pharmacology, Université de Bordeaux, Bordeaux, France; 2Pfizer Consumer Healthcare, Madison, NJ, USA Abstract: Nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen have a long history of safe and effective use as both prescription and over-the-counter (OTC analgesics/antipyretics. The mechanism of action of all NSAIDs is through reversible inhibition of cyclooxygenase enzymes. Adverse drug reactions (ADRs including gastrointestinal bleeding as well as cardiovascular and renal effects have been reported with NSAID use. In many cases, ADRs may occur because of drug–drug interactions (DDIs between the NSAID and a concomitant medication. For example, DDIs have been reported when NSAIDs are coadministered with aspirin, alcohol, some antihypertensives, antidepressants, and other commonly used medications. Because of the pharmacologic nature of these interactions, there is a continuum of risk in that the potential for an ADR is dependent on total drug exposure. Therefore, consideration of dose and duration of NSAID use, as well as the type or class of comedication administered, is important when assessing potential risk for ADRs. Safety findings from clinical studies evaluating prescription-strength NSAIDs may not be directly applicable to OTC dosing. Health care providers can be instrumental in educating patients that using OTC NSAIDs at the lowest effective dose for the shortest required duration is vital to balancing efficacy and safety. This review discusses some of the most clinically relevant DDIs reported with NSAIDs based on major sites of ADRs and classes of medication, with a focus on OTC ibuprofen, for which the most data are available. Keywords: adverse effects, nonsteroidal anti-inflammatory drugs, gastrointestinal, cardiovascular, renal

  6. An evaluation of the adverse reaction potential of three measles-mumps-rubella combination vaccines

    Directory of Open Access Journals (Sweden)

    Santos Boaventura Antônio dos

    2002-01-01

    Full Text Available Objective. To compare the incidence of adverse events following the administration of three commercially available measles-mumps-rubella (MMR combination vaccines. Methods. A randomized double-blind clinical trial was performed in 1996 that involved a total of 10 142 students 6-12 years of age in the state of Rio Grande do Sul, in Brazil. An MMR vaccine containing the Edmonston-Zagreb, Leningrad-Zagreb, and RA 27/3 strains ("vaccine A" was administered to 2 226 students (21.9% of the total; an MMR vaccine with the Moraten, Jeryl Lynn, and Wistar 27/3 strains ("vaccine B" was administered to 2 216 children (21.8%; and an MMR vaccine containing the Schwartz, Urabe AM-9, and Wistar 27/3 strains ("vaccine C" was given to 2 179 students (21.5%. A control group of 3 521 students (34.7% was not vaccinated. Both the vaccinated subjects and the control subjects were followed daily for 30 days to detect any clinical manifestations. Results. Adverse events were more frequent in the vaccinated children than in the control group (P < 0.01. In terms of causing parotitis, vaccine A had a relative risk (RR of 5.72 (95% confidence interval (CI = 3.11-10.54 when compared with vaccine B, and an RR of 2.33 (95% CI = 1.52-3.58 when compared with vaccine C. Vaccine A was also associated with an increased risk of lymphadenopathy when compared with vaccine B (RR = 3.11; 95% CI = 1.78-5.45 and with vaccine C (RR = 2.22; 95% CI = 1.35-3.66. Vaccine C was associated with an increased risk of parotitis when compared with vaccine B (RR = 2.46; 95% CI = 1.26-4.80. Three cases of aseptic meningitis were detected among the children in the study group, but only one case of vaccine-related aseptic meningitis was identified, among the children receiving vaccine A. Conclusions. The three MMR vaccines that we studied are associated with different risks of adverse events. We found vaccine A to cause more reactions than the two other vaccines, especially vaccine B. In addition

  7. German guideline for the management of adverse reactions to ingested histamine: Guideline of the German Society for Allergology and Clinical Immunology (DGAKI), the German Society for Pediatric Allergology and Environmental Medicine (GPA), the German Association of Allergologists (AeDA), and the Swiss Society for Allergology and Immunology (SGAI).

    Science.gov (United States)

    Reese, Imke; Ballmer-Weber, Barbara; Beyer, Kirsten; Fuchs, Thomas; Kleine-Tebbe, Jörg; Klimek, Ludger; Lepp, Ute; Niggemann, Bodo; Saloga, Joachim; Schäfer, Christiane; Werfel, Thomas; Zuberbier, Torsten; Worm, Margitta

    2017-01-01

    Adverse food reactions are far more often perceived than objectively verified. In our scientific knowledge on non-allergic adverse reactions including the so called histamine intolerance, there are large deficits. Due to the fact that this disorder is increasingly discussed in the media and the internet, more and more people suspect it to be the trigger of their symptoms. The scientific evidence to support the postulated link between ingestion of histamine and adverse reactions is limited, and a reliable laboratory test for objective diagnosis is lacking. This position paper by the "Food Allergy" Working Group of the German Society for Allergology and Clinical Immunology (DGAKI) in collaboration with the German Association of Allergologists (AeDA), the Society for Pediatric Allergology and Environmental Medicine (GPA), and the Swiss Society for Allergology and Immunology (SGAI) reviews the data on the clinical picture of adverse reactions to ingested histamine, summarizes important aspects and their consequences, and proposes a practical diagnostic and therapeutic approach.

  8. [Direct costs and clinical aspects of adverse drug reactions in patients admitted to a level 3 hospital internal medicine ward].

    Science.gov (United States)

    Tribiño, Gabriel; Maldonado, Carlos; Segura, Omar; Díaz, Jorge

    2006-03-01

    Adverse drug reactions (ADRs) occur frequently in hospitals and increase costs of health care; however, few studies have quantified the clinical and economic impact of ADRs in Colombia. These impacts were evaluated by calculating costs associated with ADRs in patients hospitalized in the internal medicine ward of a Level 3 hospital located in Bogotá, Colombia. In addition, salient clinical features of ADRs were identified and characterized. Intensive follow-ups for a cohort of patients were conducted for a five month period in order to detect ADRs; different ways to classify them, according to literature, were considered as well. Information was collected using the INVIMA reporting format, and causal probability was evaluated with the Naranjo algorithm. Direct costs were calculated from the perspective of payer, based on the following costs: additional hospital stay, medications, paraclinical tests, additional procedures, patient displacement to intermediate or intensive care units, and other costs. Of 836 patients admitted to the service, 268 adverse drug reactions were detected in 208 patients (incidence proportion 25.1%, occurence rate 0.32). About the ADRs found, 74.3% were classified as probable, 92.5% were type A, and 81.3% were moderate. The body system most often affected was the circulatory system (33.9%). Drugs acting on the blood were most frequently those ones associated with adverse reactions (37.6%). The costs resulting from medical care of adverse drug reactions varied from COL dollar 93,633,422 (USD dollar 35,014.92) to COL dollar 122,155,406 (USD dollar 45,680.94), according to insurance type, during the study period. Adverse drug reactions have a significant negative health and financial impact on patient welfare. Because of the substantial resources required for their medical care and the significant proportion of preventable adverse reactions, active programs of institutional pharmacovigilance are highly recommended.

  9. Filtering big data from social media--Building an early warning system for adverse drug reactions.

    Science.gov (United States)

    Yang, Ming; Kiang, Melody; Shang, Wei

    2015-04-01

    Adverse drug reactions (ADRs) are believed to be a leading cause of death in the world. Pharmacovigilance systems are aimed at early detection of ADRs. With the popularity of social media, Web forums and discussion boards become important sources of data for consumers to share their drug use experience, as a result may provide useful information on drugs and their adverse reactions. In this study, we propose an automated ADR related posts filtering mechanism using text classification methods. In real-life settings, ADR related messages are highly distributed in social media, while non-ADR related messages are unspecific and topically diverse. It is expensive to manually label a large amount of ADR related messages (positive examples) and non-ADR related messages (negative examples) to train classification systems. To mitigate this challenge, we examine the use of a partially supervised learning classification method to automate the process. We propose a novel pharmacovigilance system leveraging a Latent Dirichlet Allocation modeling module and a partially supervised classification approach. We select drugs with more than 500 threads of discussion, and collect all the original posts and comments of these drugs using an automatic Web spidering program as the text corpus. Various classifiers were trained by varying the number of positive examples and the number of topics. The trained classifiers were applied to 3000 posts published over 60 days. Top-ranked posts from each classifier were pooled and the resulting set of 300 posts was reviewed by a domain expert to evaluate the classifiers. Compare to the alternative approaches using supervised learning methods and three general purpose partially supervised learning methods, our approach performs significantly better in terms of precision, recall, and the F measure (the harmonic mean of precision and recall), based on a computational experiment using online discussion threads from Medhelp. Our design provides

  10. Collaboration in pharmacovigilance: lamotrigine and fatal severe cutaneous adverse reactions – a review of spontaneous reports

    Directory of Open Access Journals (Sweden)

    Brickel N

    2017-07-01

    Full Text Available Neil Brickel,1 Haris Shaikh,1 Andrew Kirkham,2 Greg Davies,1 Michelle Chalker,1 Pascal Yoshida3 1Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge, Middlesex, UK; 2Classic and Established Products, GlaxoSmithKline, Brentford, Middlesex, UK; 3Clinical Safety and Post-marketing Surveillance, GlaxoSmithKline KK, Tokyo, Japan Abstract: Pharmacovigilance presents many challenges, particularly when managing unpredictable, rare conditions, eg, severe cutaneous adverse reactions (SCARs. Such rare events are often only detected from spontaneous reports, which present their own limitations, particularly during a prolonged global launch schedule. GlaxoSmithKline’s routine pharmacovigilance includes regular reviews of global adverse event (AE reports and aggregate data from a central safety database. Lamotrigine is one of the several antiepileptic drugs associated with SCARs. After identification of increased rates of fatal SCAR cases with lamotrigine in Japan between September and December 2014, this analysis investigated the global incidence of fatal SCARs with lamotrigine and explored whether known risk factors may have contributed to these cases. Global fatal SCAR cases reported with lamotrigine administration from launch until January 2015 were reviewed for evidence of temporal association with dosing and the presence of risk factors, including comorbidities, concomitant medications, and noncompliance with the prescribing information (PI. Worldwide, the estimated cumulative exposure to lamotrigine was >8.4 million patient-years. Globally, there were 54,513 AE reports for lamotrigine, of which 3,454 (6.3% concerned SCARs. Of these, 122 (3.5% had a fatal outcome (attributable and nonattributable to lamotrigine, equating to 0.01 fatal SCARs per 1,000 patient-years. In Japan (estimated cumulative exposure 141,000 patient-years, 17 fatal SCARs were reported (attributable and nonattributable, equating to 0.12 per 1,000 patient

  11. Blood donors--Serious adverse reactions (SAR) 2010-2014 EFS Châteauroux, France.

    Science.gov (United States)

    Riga, A; Sapey, T; Bacanu, M; Py, J-Y; Dehaut, F

    2015-06-01

    In 2013, the national French incidence of serious adverse reactions (SAR) was 155.7 per 100,000 donations and 82% of SAR were grade 2 (French classification of SAR related to blood donors) The purpose of our study was to describe the profile of blood donator candidate which had a SAR in our center. The study contains all the SAR superior to grade 1 occurred on the site EFS Châteauroux (site and mobile blood collection) from January 2010 to October 31, 2014. We analyzed 37 parameters from the e-fit files (e-site French blood vigilance) and In-log software. We identified 82 SAR for 72,553 blood donations (incidence: 113.02 SAR per 100,000 donations). Forty-one men and 41 women, middle age 39 years (18-66). Average height: 1.68 m (1.49-1.85); average weight: 68 kg (50-98); body mass index (kg/m(2)): 24,13(18.6-31.9). All donors were Caucasian and 30% unemployed. We found 74 vasovagal syncope (VVS), 5 hematomas, 2 arterial injuries and an adverse reaction to citrate. In 90%, the SAR was immediate and of grade 2 in 85% of cases. Thirty-seven percent of SAR were first donation in connection with whole blood in 87% of cases. Regarding the seniority of donors, the number of average donations (whole blood, plasma, platelets) was 16.5. An SAR determined the stop of blood donation in 65% of cases with nearly 80% stoppage if it was a first donation. Seventy-three percent of SAR as a VVS took place during blood collection or within 5 minutes following the end of the donation. Sixty-one percent were men. Forty-four percent of cases were a first donation and 83% occurred in mobile blood collection. Average age was 36 years. The result was a permanent stop of all type of donations in 76% of cases. Twenty-seven percent of SAR as a VVS took place beyond 5 minutes after the end of the donation. Seventy-five percent were women. Thirty percent of cases were a first donation and 95% of SAR occurred in mobile blood collection. Average age was 42 years. The result was a permanent stop of

  12. More than skin deep. Ten year follow-up of delayed cutaneous adverse drug reactions (CADR).

    Science.gov (United States)

    Graudins, Linda Velta; Ly, Jenny; Trubiano, Jason; Aung, Ar Kar

    2016-10-01

    To determine the gaps in practice regarding appropriate ADR documentation and risk communication for patients diagnosed with severe cutaneous adverse drug reactions (CADR). This was a retrospective observational cohort study conducted using hospital coding and databases to identify inpatients diagnosed with CADR from January 2004 to August 2014. Hospital discharge summaries, ADR reports and pharmacy dispensing records were reviewed for ADR documentation. Patients still living in Australia and who did not opt out of being contacted were invited to be surveyed by telephone to determine their understanding of recommendations, re-exposure rates and long-term effects. Of 85 patients identified, median age was 59 (IQR 44-72) years and 47.1% were male. The most common diagnosis was TENS (49.4%). Ten patients (11.8%) died as inpatients. Of the 81 patients with a drug-related causality, 47 (58%) had appropriate documentation in all three required medical record platforms. Of the 56 eligible patients, 38 (67.9%) were surveyed; 13% had no information provided upon discharge and 26.3% patients had a mismatch in knowledge of implicated medications. No surveyed patient had a relapse of CADR, but 23.7% had a subsequent unrelated allergic reaction. Thirteen patients (34.2%) reported long-term effects. We found gaps in the accuracy of ADR documentation and communication of risk at discharge, which indicated risks to patient safety. Electronic systems are being developed to improve documentation. Written information about CADR is being provided at discharge to improve patient understanding and knowledge. © 2016 The British Pharmacological Society.

  13. [Short effect and adverse reaction of dog days plaster for allergic rhinitis].

    Science.gov (United States)

    Zhang, Hongli; Zhao, Minghui; Fu, Lixin

    2016-01-01

    To evaluate the short effect and safety of the acupoint application of dog days for allergic rhinitis. Two hundred and forty-nine patients were randomly divided into an application group (166 cases) and a placebo group (83 cases). On the first day of the first dog days, the first day of the second of the three ten-day periods of the hot season and the first day of the last of the three ten-day periods of the hot season, acupoint application was adopted mainly at Dazhui (GV 14), Feishu (BL 13), Pishu (BL 20) and Shenshu (BL 23) in the application group. The plaster was made of Chinese herbs, including Baijiezi (semen brassicae), Xixin (asarum), Yanhusuo (corydalis tuber) and Gansui (euphorbia kansui). Buckwheat plaster without medical ingredient was used in the placebo group. The application was pasted for 2-6 h every time. On the first three days of all the three periods of dog days, treatment was used continuously. The whole period of dog days was made into one course. The changes of symptom and syndrome scores, visual analogue scale (VAS) for symptom before and after treatment and the adverse reaction with the condition disposed were observed in the two groups. After treatment, the symptom and syndrome scores and VAS for symptom were improved compared with those before treatment in the two groups (all P reaction rates were 4.2% (7/166), 2.4% (2/83) respectively, with no statistical significance between the two groups (P > 0.05). The dog days plaster achieves obvious effect with good safety for allergic rhinitis.

  14. [Safety of SGLT2 inhibitors. A review of the adverse drug reactions registered in a national database].

    Science.gov (United States)

    Esteban-Jiménez, O; Navarro-Pemán, C; Urieta-González, L

    2017-11-25

    To analyse the adverse drug reactions (ADRs) caused by Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i) notified in Spain since they have been on the market. An analysis was made of all the notifications registered in the Spanish Pharmacovigilance System of drugs for human use, arising from the use of SGLT2i. A total of 311 notifications were recorded, of which 169 (54.34%) were related to dapagliflozin, 81 (26.05%) to empagliflozin, and 61 (19.61%) to canagliflozin. There was a ratio of 52.1% women to 47.9% men. The mean age was 62.07±12.17years. There were 167 (53.7%) notifications were classified as non-serious and 144 (46.3%) as serious. A total of 534 ADRs were notified, with the most common being urinary tract infections in 37 (6.9%) cases, diabetic ketoacidosis in 30 (5.6%), balanoposthitis in 24 (4.5%), ketoacidosis in 16 (3%), vulvovaginal candidiasis in 16 (3%), dizzy spells in 11 (2.1%), and 10 (1.9%) with dysuria, Candida balanitis, and vulvovaginal pruritus. As regards the outcomes of the 534 ADRs, 55.6% recovered with no sequelae, with 14% still recovering, 4.9% not recovered, fatal in 1.1%, and unknown in 24.3%. The majority of the ADRs notified are infections of the urogenital tract, ketoacidosis, and kidney damage. Although the majority of the former were not serious, the ketoacidosis and kidney damage were, leading to hospital admission and being life threatening in some patients. For these reasons, it is recommended that they are, prescribed with caution, the warnings published by the health authorities consulted, as well as notify any ADR that is suspected in this therapeutic group, in order to improve and provide us with further knowledge. Copyright © 2017 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España, S.L.U. All rights reserved.

  15. [Methodology for Estimating the Risk of Adverse Drug Reactions in Pregnant Women: Analysis of the Japanese Adverse Drug Event Report Database].

    Science.gov (United States)

    Sakai, Takamasa; Ohtsu, Fumiko; Sekiya, Yasuaki; Mori, Chiyo; Sakata, Hiroshi; Goto, Nobuyuki

    2016-01-01

    Safety information regarding drug use during pregnancy is insufficient. The present study aimed to establish an optimal signal detection method to identify adverse drug reactions in pregnant women and to evaluate information in the Japanese Adverse Drug Event Report (JADER) database between April 2004 and November 2014. We identified reports on pregnant women using the Standardised MedDRA Queries. We calculated the proportional reporting ratio (PRR) and reporting odds ratio (ROR) of the risk factors for the two known risks of antithyroid drugs and methimazole (MMI) embryopathy, and ritodrine and fetal/infant cardiovascular events. The PRR and ROR values differed between all reports in the JADER database and those on pregnant women, affecting whether signal detection criteria were met. Therefore we considered that reports on pregnant women should be used when risks associated with pregnancy were determined using signal detection. Analyses of MMI embryopathy revealed MMI signals [PRR, 159.7; ROR, 669.9; 95% confidence interval (CI), 282.4-1588.7] but no propylthiouracil signals (PRR, 1.98; ROR, 2.0; 95%CI, 0.3-15.4). These findings were consistent with those of reported risks. Analyses of fetal/infant cardiovascular events revealed ritodrine signals (PRR, 2.1; ROR, 2.1; 95%CI, 1.4-3.3). These findings were also consistent with reported risks. Mining the JADER database was helpful for analyzing adverse drug reactions in pregnant women.

  16. Systematic review of paediatric studies of adverse drug reactions from pharmacovigilance databases.

    Science.gov (United States)

    Cliff-Eribo, Kennedy Obebi; Sammons, Helen; Choonara, Imti

    2016-10-01

    To perform a systematic review of studies describing paediatric adverse drug reactions (ADRs) conducted from national pharmacovigilance databases. A systematic literature search of studies describing results for paediatric ADRs from national pharmacovigilance databases was performed. PubMed database, Embase and MEDLINE were searched up to March 2015. The descriptive studies included were analysed for country of origin, reporters, and ADR reporting rate, drugs, ADRs and number of fatalities. 20 studies were identified. Doctors were the largest group of reporters in all the studies, and with more consumer reports seen in USA. The studies ranged from 3 - 37 years. The highest ADR reporting rate was 1458 reports per year per million children in Cuba. Antibiotics and vaccines were the most frequently reported drugs, in almost all the studies. The most frequent ADRs were skin and nervous system disorders. The highest proportion of fatalities and serious reports was from North America. Drugs used for treating attention deficit hyperactivity disorders (ADHD) and isotretinoin were the most frequently reported drugs for ADRs in North America. There were geographical differences in drugs responsible for ADRs and their seriousness, especially in North America. Very few studies were conducted in Asia and Latin America, none were found from Africa.

  17. Medicinal plant reported with adverse reactions in Cuba: potential interactions with conventional drugs

    Directory of Open Access Journals (Sweden)

    Ioanna Martínez

    2015-04-01

    Full Text Available Context: Herbal drugs are a mixture of active compounds and the chemical complexity of each formulation increase with the possibility of interactions between them and conventional drugs. Many mechanisms are implicated in the interactions; scientific community has dedicated the attentions to enzymes as P-gp and CYP450. Aims: To investigate in the literature the principal plants with suspicions of adverse reactions in Cuba and their potential interactions with conventional drugs. Methods: PubMed was the database used as source of information until February 2014. Key words: Herb-Drug, Drug-Plant, Herbal–Drug, Interactions with scientific names of plants was used. Information was structured and analysed with EndNote X4. Analysis and integration of the information: Allium sativum L. (garlic was the plant with the high number of studies related with CYP450 and P-gp. Plants with great demand as Morinda citrifolia L. (noni, Psidium guajava L. (guayaba, Zingiber officinale Roscoe (ginger and Eucalyptus spp. (eucalyptus have a very small number of studies. The professionals of the health should keep in mind the possibility of interactions between herbal products and conventional drugs to increase the effectiveness of phytotherapy. Conclusions: It is necessary enhance reports and investigations and to put to disposition of the system of health information on the interactions of plants and to stimulate the investigation that offers information for the rational use of our medicinal plants.

  18. Adverse reactions to foods and food allergy: development and reproducibility of a questionnaire for clinical diagnosis.

    Science.gov (United States)

    Lyra, Nilza R S; Motta, Maria E F A; Rocha, Luiz A R; Solé, Dirceu; Peixoto, Décio M; Rizzo, José A; Taborda-Barata, Luis; Sarinho, Emanuel S C

    2013-01-01

    Objective. To develop a questionnaire as a screening tool for adverse reactions to foods in children and to assess the technical reproducibility by test-retest. Methods. Reproducibility of the questionnaire was performed by the literature review, preparing the preliminary questionnaire, peer review, pretest, and retest analysis. The study of the test-retest reproducibility was cross-sectional and descriptive. Kappa coefficient was used to study the reproducibility of the questionnaire. The sample consisted of 125 2-4 year-old children from 15 daycare centers in Recife, Brazil, and interviews with parents or caregivers were used to collect data. Results. From the total children, sixty-three were boys (50.4%), forty-six were two years old (36.8%), forty-seven were three years old (37.6%), and thirty-two were four years old (25.6%). Forty caregivers reported that their child had health problems with food. Most frequently reported offending foods were milk, peanuts, shrimp, and chocolate. Nine questions showed a good Kappa index (≥0,6). Conclusions. The questionnaire used needs to be resized and reshaped on the basis of the issues with good internal consistency and reproducibility. The use of a validated and reproducible questionnaire in the children represents an important contribution towards assessing an eventual rise in overt food allergy.

  19. Adverse Reactions to Foods and Food Allergy: Development and Reproducibility of a Questionnaire for Clinical Diagnosis

    Directory of Open Access Journals (Sweden)

    Nilza R. S. Lyra

    2013-01-01

    Full Text Available Objective. To develop a questionnaire as a screening tool for adverse reactions to foods in children and to assess the technical reproducibility by test-retest. Methods. Reproducibility of the questionnaire was performed by the literature review, preparing the preliminary questionnaire, peer review, pretest, and retest analysis. The study of the test-retest reproducibility was cross-sectional and descriptive. Kappa coefficient was used to study the reproducibility of the questionnaire. The sample consisted of 125 2–4 year-old children from 15 daycare centers in Recife, Brazil, and interviews with parents or caregivers were used to collect data. Results. From the total children, sixty-three were boys (50.4%, forty-six were two years old (36.8%, forty-seven were three years old (37.6%, and thirty-two were four years old (25.6%. Forty caregivers reported that their child had health problems with food. Most frequently reported offending foods were milk, peanuts, shrimp, and chocolate. Nine questions showed a good Kappa index (≥0,6. Conclusions. The questionnaire used needs to be resized and reshaped on the basis of the issues with good internal consistency and reproducibility. The use of a validated and reproducible questionnaire in the children represents an important contribution towards assessing an eventual rise in overt food allergy.

  20. Methionine and Choline Deficient (MCD) Model in Predicting Adverse Drug Reactions in Human NASH.

    Science.gov (United States)

    Li, Hui; Toth, Erica; Cherrington, Nathan J

    2017-11-14

    In the past few decades, great conceptual and technological advances have been made in the field of toxicology, but animal model-based research still remains one of the most widely-used and readily available tools for furthering our current knowledge. However, animal models are not perfect in predicting all systemic toxicity in humans. Extrapolating animal data to accurately predict human toxicities remains a challenge, and researchers are obligated to question the appropriateness of their chosen animal model. This paper provides an assessment of the utility of the methionine choline deficient (MCD) diet fed animal model in reflecting human nonalcoholic steatohepatitis (NASH) and the potential risks of adverse drug reactions (ADRs) and toxicities that are associated with the disease. As a commonly used NASH model, the MCD model fails to exhibit most metabolic abnormalities in a similar manner to the human disease. The MCD model, on the other hand, closely resembles human NASH histology, and reflects signatures of drug transporter alterations in humans. Due to the nature of the MCD model, it should be avoided in studies of NASH pathogenesis, metabolic parameter evaluation and biomarker identification. but it can be used to accurately predict altered drug disposition due to NASH-associated transporter alterations. © The Author 2017. Published by Oxford University Press on behalf of the Society of Toxicology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  1. Innovations in monitoring of adverse drug reactions: the role of a technical advisor.

    Science.gov (United States)

    Ramalingam, S; Ponnuswamy, T K; Sivan, Y S

    2013-01-01

    Adverse drug reactions (ADRs) have ethical implications. These include assessment of the risk-benefit ratio and re-administering informed consent based on the new ADRs identified. The Indian Council of Medical Research ethical guidelines mandate the scrutiny of ADR; and the standard operating procedures of the ethics committee of the authors' medical school endorse this line. However, institutional review board members are often hardpressed for time and are unable to analyse all the reported ADRs as thoroughly as required. This calls for a dedicated system for the scrutiny of ADRs. This paper seeks to share the experience of development and implementation of a review mechanism for ADR monitoring. The authors report an innovation in ADR monitoring by appointing a technical advisor on ADR (TA-ADR). During routine assessment, an unusual occurrence of ADRs was noticed from internal and external sites which were related to the study drug, which in turn resulted in the trial being put on hold. This system is being reported here for possible adoption by others.

  2. Recognizing Severe Adverse Drug Reactions: Two Case Reports After Switching Therapies to the Same Generic Company.

    Science.gov (United States)

    Gallelli, Luca; Gallelli, Giuseppe; Codamo, Giuseppe; Argentieri, Angela; Michniewicz, Andzelika; Siniscalchi, Antonio; Stefanelli, Roberta; Cione, Erika; Caroleo, Maria C; Longo, Paola; De Sarro, Giovambattista

    2016-01-01

    Generic formulations represent a way to reduce the costs of brand compounds when their patent is expired. While, the bio-equivalence in generic drugs is guaranteed, some excipients as well as dyes could be different and this could reduce the drug safety. Herein, we report the development of Adverse Drug Reactions (ADRs) in two patients after the switch from brand to generic formulations. We have tested cytochrome P450 enzymes expression as well as drug serum levels. None of these markers were altered. Checking deeply into both patient's medical history, they harbored poly-sensitivity or allergy to pollen and graminacea and used different active ingredients for different health problems coming from the same generic company Almus(®). This company used different dyes and excipients compared to the branded drugs made by distinguished companies. In conclusion, we strongly suggest to both pharmacists and physicians to be careful in giving the advice to change the drug, thinking to reduce health sanitary costs without considering the personal clinical history of each one. Paradoxically this behavior is causing other health issues, bringing to an increase of the overall costs for patients as well as for National Health System.

  3. Knowledge, Attitude, and Practice towards Medication Errors and Adverse Drug Reaction Reporting among Medicine Students

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    Maryam Aghakouchakzadeh

    2017-03-01

    Full Text Available Background: The most common types of medical error are medication errors (MEs which defined as any preventable event that may be caused by an inappropriate medication usage and lead to an adverse drug reaction (ADR event in patients. In recent years, different approaches have been proposed to reduce MEs, one of which is reporting ADRs. The present study was designed to assess the Knowledge, Attitude and Practice (KAP of medicine students towards MEs and ADRs reporting.Method: The validated 12-item questionnaire included subsequently 4 questions, 5 items and the final 3 questions related to the knowledge, attitude, and practice that was given to each participant before and after of the clerkship course. The study population were 40 students of fourth-year of medicine.Results: Demographic features of the participants have no significant difference. Medicine students had a poor KAP towards MEs. Only 8% of respondents had general knowledge about MEs and 50% of students believed MEs are inevitable events, less than 20% of them were acquainted with 5 rules of prescriptions. Students had good knowledge and attitude but poor practice towards ADRs reporting. 55% of participants were aware of their responsibility of ADRs reporting but only 5% of respondents were acquainted with ADRs reporting method and the ADR center in the hospitals.Conclusion: The educational intervention, alteration in medicine student’s curriculum, and hold the interactive clerkship for health care professionals can improve the KAP towards ADRs reporting and diminish of the preventable medication errors.

  4. Factors Affecting the Timing of Signal Detection of Adverse Drug Reactions.

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    Masayuki Hashiguchi

    Full Text Available We investigated factors affecting the timing of signal detection by comparing variations in reporting time of known and unknown ADRs after initial drug release in the USA. Data on adverse event reactions (AERs submitted to U.S. FDA was used. Six ADRs associated with 6 drugs (rosuvastatin, aripiprazole, teriparatide, telithromycin, exenatide, varenicline were investigated: Changes in the proportional reporting ratio, reporting odds ratio, and information component as indexes of signal detection were followed every 3 months after each drugs release, and the time for detection of signals was investigated. The time for the detection of signal to be detected after drug release in the USA was 2-10 months for known ADRs and 19-44 months for unknown ones. The median lag time for known and unknown ADRs was 99.0-122.5 days and 185.5-306.0 days, respectively. When the FDA released advisory information on rare but potentially serious health risks of an unknown ADR, the time lag to report from the onset of ADRs to the FDA was shorter. This study suggested that one factor affecting signal detection time is whether an ADR was known or unknown at release.

  5. A systematic investigation of computation models for predicting Adverse Drug Reactions (ADRs.

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    Qifan Kuang

    Full Text Available BACKGROUND: Early and accurate identification of adverse drug reactions (ADRs is critically important for drug development and clinical safety. Computer-aided prediction of ADRs has attracted increasing attention in recent years, and many computational models have been proposed. However, because of the lack of systematic analysis and comparison of the different computational models, there remain limitations in designing more effective algorithms and selecting more useful features. There is therefore an urgent need to review and analyze previous computation models to obtain general conclusions that can provide useful guidance to construct more effective computational models to predict ADRs. PRINCIPAL FINDINGS: In the current study, the main work is to compare and analyze the performance of existing computational methods to predict ADRs, by implementing and evaluating additional algorithms that have been earlier used for predicting drug targets. Our results indicated that topological and intrinsic features were complementary to an extent and the Jaccard coefficient had an important and general effect on the prediction of drug-ADR associations. By comparing the structure of each algorithm, final formulas of these algorithms were all converted to linear model in form, based on this finding we propose a new algorithm called the general weighted profile method and it yielded the best overall performance among the algorithms investigated in this paper. CONCLUSION: Several meaningful conclusions and useful findings regarding the prediction of ADRs are provided for selecting optimal features and algorithms.

  6. Erythema multiforme-like eruption from a slimming drug preparation cutaneous adverse drug reaction

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    Linda Tognetti

    2011-01-01

    Full Text Available We report a case of a 34-year-old woman presenting with an erythema multiforme (EM-like eruption. Lesions developed after a 12-day treatment with a slimming drug preparation (food integrator with thermogenic activity and a herbal remedy (pilosella tincture. Serological investigations excluded viral or bacterial infections. Patch testing with galenic preparations of both drugs demonstrated sensitization to the slimming drug preparation. According to literature reports and immune-chemical properties, those components that are likely to have triggered the skin eruption are clorazepate dipotassium and theobromine. Their interaction with other two constituents such as pseudoephedrine hydrochloride and dehydrocholic acid may have caused the adverse reaction by means of a summation effect. There are no reports specifically about EM caused by a slimming drug preparation and no studies have identified thermogenic pills as cause of EM/EM-like eruption. Weight-loss compounds in slimming preparations should be kept in mind as a possible cause of drug-induced EM-like eruption.

  7. Adverse Food Reaction and Functional Gastrointestinal Disorders: Role of the Dietetic Approach.

    Science.gov (United States)

    Pasqui, Francesca; Poli, Carolina; Colecchia, Antonio; Marasco, Giovanni; Festi, Davide

    2015-09-01

    Bloating, abdominal discomfort or pain, disturbed bowel habits are very common symptoms, frequently reported by the patients soon after food ingestion. These symptoms may occur in different clinical conditions, such as functional bowel disorders, food adverse reactions, gluten-related syndromes, which frequently are interrelated. Consequently, in clinical practice, it is necessary to perform a correct diagnosis in order to identify, for the single patient, the most appropriate therapeutic strategy, which may include not only specific drugs, but also, and mainly, life style changes (healthy nutritional behavior and constant physical activity). The aim of this review is to provide to the general physician, according to the available evidence, the most appropriate diagnostic work-ups for recognizing the different clinical scenarios (i.e. food allergy and intolerance, functional bowel diseases, gluten-related syndromes), to identify their clinical interrelationships and to suggest the most appropriate management. In fact, as far as food intolerances are concerned, it is well known that the number of patients who believe that their symptoms are related to food intolerance is increasing and consequently they restrict their diet, possibly causing nutritional deficiencies. Furthermore, there is an increasing use of unconventional diagnostic tests for food intolerance which lack accurate scientific evidence; the application of their results may induce misdiagnosis and unhealthy therapeutic choices. Consequently the recognition of food intolerance has to be performed on the basis of reliable tests within an agreed diagnostic workup.

  8. Neuropsychiatric adverse drug reactions in children initiated on montelukast in real-life practice.

    Science.gov (United States)

    Benard, Brigitte; Bastien, Valérie; Vinet, Benjamin; Yang, Roger; Krajinovic, Maja; Ducharme, Francine M

    2017-08-01

    Although montelukast is generally well tolerated, postmarketing studies have reported serious neuropsychiatric adverse drug reactions (ADRs) leading to a United States Food and Drug Administration black box warning. The objective of this study was to determine the incidence of neuropsychiatric ADRs leading to discontinuation of montelukast in asthmatic children.We conducted a retrospective cohort study in children aged 1-17 years initiated on montelukast. In a nested cohort study, children initiated on montelukast as monotherapy or adjunct therapy to inhaled corticosteroids (ICS) were matched to those initiated on ICS monotherapy. A non-leading parental interview served to ascertain the occurrence of any ADRs with any asthma medication, and circumstances related to, and evolution of, the event.Out of the 106 participants who initiated montelukast, most were male (58%), Caucasian (62%) with a median (interquartile range) age of 5 (3-8) years. The incidence (95% CI) of drug cessation due to neuropsychiatric ADRs was 16 (10-26)%, mostly occurring within 2 weeks. Most frequent ADRs were irritability, aggressiveness and sleep disturbances. The relative risk of neuropsychiatric ADRs associated with montelukast versus ICS was 12 (2-90).In the real-life setting, asthmatic children initiated on montelukast experienced a notable risk of neuropsychiatric ADRs leading to drug cessation, that is significantly higher than that associated with ICS. Copyright ©ERS 2017.

  9. Adverse drug reactions in a primary care population prescribed non-steroidal anti-inflammatory drugs.

    Science.gov (United States)

    Koffeman, Aafke R; Van Buul, Amanda R; Valkhoff, Vera E; Jong, Geert W 't; Bindels, Patrick J E; Sturkenboom, Miriam C J M; Van der Lei, Johan; Luijsterburg, Pim A J; Bierma-Zeinstra, Sita M A

    2015-01-01

    To determine how often patients with musculoskeletal (MSK) complaints prescribed a non-steroidal anti-inflammatory drug (NSAID) subsequently consult their general practitioner (GP) with a non-serious adverse drug reaction (ADR). Cohort study. A healthcare database containing the electronic GP medical records of over 1.5 million patients throughout the Netherlands. A total of 16 626 adult patients with MSK complaints prescribed an NSAID. The patients' medical records were manually assessed for the duration of NSAID use for a maximum of two months, and consultations for complaints predefined as potential ADRs were identified. Subsequently, the likelihood of an association with the NSAID use was assessed and these potential ADRs were categorized as likely, possible, or unlikely ADRs. In total, 961 patients (6%) consulted their GP with 1227 non-serious potential ADRs. In 174 patients (1%) at least one of these was categorized as a likely ADR, and in a further 408 patients (2.5%) at least one was categorized as a possible ADR. Dyspepsia was the most frequent likely ADR, followed by diarrhoea and dyspnoea (respectively 34%, 8%, and 8% of all likely ADRs). Of the patients with MSK complaints prescribed an NSAID, almost one in 30 patients re-consulted their GP with a complaint likely or possibly associated with the use of this drug. The burden of such consultations for non-serious ADRs should be taken into account by GPs when deciding whether treatment with an NSAID is appropriate.

  10. Antibiotic-Related Adverse Drug Reactions at a Tertiary Care Hospital in South Korea

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    In Young Jung

    2017-01-01

    Full Text Available Background. Adverse drug reactions (ADRs are any unwanted/uncomfortable effects from medication resulting in physical, mental, and functional injuries. Antibiotics account for up to 40.9% of ADRs and are associated with several serious outcomes. However, few reports on ADRs have evaluated only antimicrobial agents. In this study, we investigated antibiotic-related ADRs at a tertiary care hospital in South Korea. Methods. This is a retrospective cohort study that evaluated ADRs to antibiotics that were reported at a 2400-bed tertiary care hospital in 2015. ADRs reported by physicians, pharmacists, and nurses were reviewed. Clinical information reported ADRs, type of antibiotic, causality assessment, and complications were evaluated. Results. 1,277 (62.8% patients were considered antibiotic-related ADRs based on the World Health Organization-Uppsala Monitoring Center criteria (certain, 2.2%; probable, 35.7%; and possible, 62.1%. Totally, 44 (3.4% patients experienced serious ADRs. Penicillin and quinolones were the most common drugs reported to induce ADRs (both 16.0%, followed by third-generation cephalosporins (14.9%. The most frequently experienced side effects were skin manifestations (45.1% followed by gastrointestinal disorders (32.6%. Conclusion. Penicillin and quinolones are the most common causative antibiotics for ADRs and skin manifestations were the most frequently experienced symptom.

  11. Distant Supervision with Transductive Learning for Adverse Drug Reaction Identification from Electronic Medical Records

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    Siriwon Taewijit

    2017-01-01

    Full Text Available Information extraction and knowledge discovery regarding adverse drug reaction (ADR from large-scale clinical texts are very useful and needy processes. Two major difficulties of this task are the lack of domain experts for labeling examples and intractable processing of unstructured clinical texts. Even though most previous works have been conducted on these issues by applying semisupervised learning for the former and a word-based approach for the latter, they face with complexity in an acquisition of initial labeled data and ignorance of structured sequence of natural language. In this study, we propose automatic data labeling by distant supervision where knowledge bases are exploited to assign an entity-level relation label for each drug-event pair in texts, and then, we use patterns for characterizing ADR relation. The multiple-instance learning with expectation-maximization method is employed to estimate model parameters. The method applies transductive learning to iteratively reassign a probability of unknown drug-event pair at the training time. By investigating experiments with 50,998 discharge summaries, we evaluate our method by varying large number of parameters, that is, pattern types, pattern-weighting models, and initial and iterative weightings of relations for unlabeled data. Based on evaluations, our proposed method outperforms the word-based feature for NB-EM (iEM, MILR, and TSVM with F1 score of 11.3%, 9.3%, and 6.5% improvement, respectively.

  12. Erythema multiforme-like eruption from a slimming drug preparation cutaneous adverse drug reaction.

    Science.gov (United States)

    Tognetti, Linda; Giorgini, Simonetta; Lotti, Torello

    2011-07-01

    We report a case of a 34-year-old woman presenting with an erythema multiforme (EM)-like eruption. Lesions developed after a 12-day treatment with a slimming drug preparation (food integrator with thermogenic activity) and a herbal remedy (pilosella tincture). Serological investigations excluded viral or bacterial infections. Patch testing with galenic preparations of both drugs demonstrated sensitization to the slimming drug preparation. According to literature reports and immune-chemical properties, those components that are likely to have triggered the skin eruption are clorazepate dipotassium and theobromine. Their interaction with other two constituents such as pseudoephedrine hydrochloride and dehydrocholic acid may have caused the adverse reaction by means of a summation effect. There are no reports specifically about EM caused by a slimming drug preparation and no studies have identified thermogenic pills as cause of EM/EM-like eruption. Weight-loss compounds in slimming preparations should be kept in mind as a possible cause of drug-induced EM-like eruption.

  13. Drug-drug interactions and adverse drug reactions in polypharmacy among older adults: an integrative review

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    Maria Cristina Soares Rodrigues

    Full Text Available ABSTRACT Objective: to identify and summarize studies examining both drug-drug interactions (DDI and adverse drug reactions (ADR in older adults polymedicated. Methods: an integrative review of studies published from January 2008 to December 2013, according to inclusion and exclusion criteria, in MEDLINE and EMBASE electronic databases were performed. Results: forty-seven full-text studies including 14,624,492 older adults (≥ 60 years were analyzed: 24 (51.1% concerning ADR, 14 (29.8% DDI, and 9 studies (19.1% investigating both DDI and ADR. We found a variety of methodological designs. The reviewed studies reinforced that polypharmacy is a multifactorial process, and predictors and inappropriate prescribing are associated with negative health outcomes, as increasing the frequency and types of ADRs and DDIs involving different drug classes, moreover, some studies show the most successful interventions to optimize prescribing. Conclusions: DDI and ADR among older adults continue to be a significant issue in the worldwide. The findings from the studies included in this integrative review, added to the previous reviews, can contribute to the improvement of advanced practices in geriatric nursing, to promote the safety of older patients in polypharmacy. However, more research is needed to elucidate gaps.

  14. An educational intervention to improve nurses’ knowledge, attitude, and practice toward reporting of adverse drug reactions

    Science.gov (United States)

    Hanafi, Somayeh; Torkamandi, Hassan; Hayatshahi, Alireza; Gholami, Kheirollah; Shahmirzadi, Nikinaz Ashrafi; Javadi, Mohammad Reza

    2014-01-01

    Background: The reporting of adverse drug reactions (ADRs) by nurses in hospitals is very important. Aims: This study was aimed at investigating the impact of an educational intervention to improve ADR reporting and whether trained nurses had better knowledge, attitude, and practice toward ADR reporting. Materials and Methods: A total of 300 nurses in a tertiary care teaching hospital in Tehran, Iran were evaluated with a knowledge, attitude, and practice (KAP) questionnaire regarding ADR reporting in March 2010. After this, an educational program about ADR was provided to nurses. Then the nurses were re-evaluated by the same questionnaire. Comparisons were made of the attitude and knowledge within nurses, before and after education. Data were analyzed using SPSS software. P nurses before the intervention was significantly less than the knowledge after the intervention (P = 0.001). Also, there was a significant effect on attitude (P = 0.002). During the follow-up period of 4 months after the intervention, 26 spontaneous reports were received. Conclusion: Continuous ADR educational program, training, and integration of ADRs’ reporting into the activities of the nurses would likely improve ADR reporting. PMID:24554968

  15. Estimation of the prevalence of adverse drug reactions from social media.

    Science.gov (United States)

    Nguyen, Thin; Larsen, Mark E; O'Dea, Bridianne; Phung, Dinh; Venkatesh, Svetha; Christensen, Helen

    2017-06-01

    This work aims to estimate the degree of adverse drug reactions (ADR) for psychiatric medications from social media, including Twitter, Reddit, and LiveJournal. Advances in lightning-fast cluster computing was employed to process large scale data, consisting of 6.4 terabytes of data containing 3.8 billion records from all the media. Rates of ADR were quantified using the SIDER database of drugs and side-effects, and an estimated ADR rate was based on the prevalence of discussion in the social media corpora. Agreement between these measures for a sample of ten popular psychiatric drugs was evaluated using the Pearson correlation coefficient, r, with values between 0.08 and 0.50. Word2vec, a novel neural learning framework, was utilized to improve the coverage of variants of ADR terms in the unstructured text by identifying syntactically or semantically similar terms. Improved correlation coefficients, between 0.29 and 0.59, demonstrates the capability of advanced techniques in machine learning to aid in the discovery of meaningful patterns from medical data, and social media data, at scale. Copyright © 2017 Elsevier B.V. All rights reserved.

  16. Pharmacy student driven detection of adverse drug reactions in the community pharmacy setting.

    Science.gov (United States)

    Christensen, Søren Troels; Søndergaard, Birthe; Honoré, Per Hartvig; Bjerrum, Ole Jannik

    2011-04-01

    Post-marketing safety studies of adverse drug reactions (ADRs) form an important part of pharmacovigilance. Countries having a formal pharmacovigilance system to a large extent rely on voluntary ADR reporting from health professionals through spontaneous report systems. The contribution of pharmacists in ADR reporting, although varies significantly among countries. Pharmacists in community pharmacies are in a unique position for detection of experienced ADRs by the drug users. The study reports from a study on community pharmacy internship students' proactive role in ADR detection through direct encountering and questioning with drug users. Pharmacy students undertaking internship in a community pharmacy were approached. Thirteen students from nine community pharmacies participated in the project as data collectors. Prior to the study students attended an educational seminar focusing on ADR detection and reporting in general. Ibuprofen was chosen as the drug of study. Pharmacy students approached recurrent drug users purchasing the drug. Participating users were asked about experienced ADRs linked to ibuprofen use. Reported ADRs were collected and analysed. Hundred and twenty eight ibuprofen users participated in the study out of who thirty three reported forty five ADRs possibly linked to ibuprofen use. The reported ADRs followed earlier reported patterns of distribution with gastric pain showing up as the most commonly reported symptom followed by heartburn, nausea, diarrhoea and constipation. Through adequate training community pharmacy internship students get competencies and are capable of detecting and reporting ADRs through direct questions to drug users. Copyright © 2010 John Wiley & Sons, Ltd.

  17. Spontaneous monitoring of adverse reactions to drugs by Italian dermatologists: a pilot study. Gruppo Italiano Studi Epidemiologici in Dermatologia.

    Science.gov (United States)

    1991-01-01

    During 1988, the Gruppo Italiano Studi Epidemiologici in Dermatologia (GISED) coordinated a pilot study aimed at evaluating the feasibility of a system for spontaneous monitoring of adverse drug reactions in dermatological practice in Italy. Approximately 400 dermatologists were asked to collaborate, and 141 agreed to the study. Procedures similar to those well established in other surveillance programs (including the use of standard forms and standardized assessment procedure) were adopted. In a 2-month period 775 reports were collected, of which 711 were maintained after careful evaluation. The general profile of the adverse reactions reported was in accordance with the experience derived by other spontaneous surveillance programs. The main purpose of spontaneous reporting systems is the identification of new reactions, and a model analysis was proposed, in our study, with reference to skin reactions to bamifylline. The demonstration of the feasibility of a drug-monitoring program in Italy, where little tradition exists in the area, is the most important result of our study.

  18. Hospital admissions due to adverse drug reactions in the elderly. A meta-analysis.

    Science.gov (United States)

    Oscanoa, T J; Lizaraso, F; Carvajal, Alfonso

    2017-06-01

    It is currently admitted that adverse drug reactions (ADRs) account for a great burden of disease. Of particular concern are ADR-induced hospital admissions, particularly in the elderly; they receive most of the medications and they are the most prone to develop ADRs. Therefore, our aim was to carry out a study of ADR-induced hospital admissions focused on the elderly population. For the purpose, a systematic review and meta-analysis was performed of those studies addressing ADR-induced hospital admissions in patients over 60 years of age. A computerized search of the literature was carried out in the main databases. The search spans from 1988 to 2015. A pooled prevalence figure was calculated with 95% CIs; heterogeneity was also explored. The final number of selected articles was 42; all of them were published between January 1988 and August 2015. The overall average percentage of hospital admissions was 8.7% (95% CI, 7.6-9.8%). NSAIDs are one of the medication classes more frequently related to these admissions (percentages range from 2.3 to 33.3%). Inappropriate medication as a risk factor was studied in nine studies, four found a statistically significant relationship between those medications and hospital admissions. Circa one in ten hospital admissions of older patients are due to ADRs. A great burden of disease is due to a few and identifiable medication classes; in most of the cases, the reactions are well known and probably preventable. A sense of purpose and determination is needed by health authorities to face this problem. Doctors, on their part, should be aware when prescribing some specific identifiable medications to these patients. 1. One in ten hospital admissions in older patients are due to ADRs; NSAIDs are the medications the most related with these admissions, followed by other common medications used in patients of this age, such as beta-blockers. 2. A great burden of disease is due to medications that are intended to cure or alleviate

  19. Ramadan fasting does not adversely affect neuromuscular performances and reaction times in trained karate athletes.

    Science.gov (United States)

    Zarrouk, Nidhal; Hammouda, Omar; Latiri, Imed; Adala, Hela; Bouhlel, Ezzedine; Rebai, Haithem; Dogui, Mohamed

    2016-01-01

    The present study aimed to investigate the concomitant effects of Ramadan intermittent fast (RIF) and muscle fatigue on neuromuscular performances and reaction times in young trained athletes. Eight karate players (17.2 ± 0.5 years) were tested on three sessions: during a control period (S1: one week before Ramadan), and during the first (S2) and the fourth week of RIF (S3). Dietary intake and anthropometric measurements were assessed before each session. During each test session, participants performed maximal voluntary isometric contractions (MVC) and a submaximal contraction at 75 % MVC until exhaustion (T lim ) of the right elbow flexors. Surface electromyography was recorded from biceps brachii muscle during MVC and T lim . Simple (SRT) and choice (CRT) reaction times were evaluated at rest and just after T lim in a random order. The total daily energy (S2: +19.5 %, p < 0.05; S3: +27.4 %, p < 0.01) and water (S2: +26.8 %, p < 0.01; S3: +23.2 %, p < 0.05) intake were significantly increased during RIF. However, neither body mass nor body mass index was altered by RIF (F (2,14) = 0.80, p = 0.47 and F (2,14) = 0.78, p = 0.48, respectively). In addition, T lim (F (2,14) = 2.53, p = 0.12), MVC (F (2,14) = 0.51, p = 0.61) and associated electrical activity (F (2,14) = 0.13, p = 0.88) as well as neuromuscular efficiency (F (2,14) = 0.27, p = 0.76) were maintained during RIF. Moreover, neither SRT nor CRT was affected by RIF (F (2,14) = 1.82, p = 0.19 and F (2,14) = 0.26, p = 0.78, respectively) or neuromuscular fatigue (F (1,7) = 0.0002, p = 0.98 and F (1,7) = 3.78, p = 0.09, respectively). The present results showed that RIF did not adversely affect the neuromuscular performances and anthropometric parameters of elite karate athletes who were undertaking their usual training schedule. In addition, neither RIF nor neuromuscular fatigue poorly affects reaction

  20. ANALISIS ADVERSE DRUG REACTIONS OBAT ANTI RETROVIRAL PADA PENGOBATAN PASIEN HIV/AIDS DI RSUD GUNUNG JATI CIREBON TAHUN 2013

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    Nur Rahmi Hidayati

    2016-05-01

    Full Text Available Acquired Immunodeficiency Syndrome (AIDS is a disease caused by infection with Human Immunodeficiency Virus (HIV. The pharmacology treatment for the infection was antiretroviral therapy. The problem from the use of antiretroviral drugs (ARV is the emergence of unwanted drug reactions (adverse drug reaction. The purpose of this study was to identify and analyze the incidence of adverse drug reactions from the use of antiretroviral drugs in the treatment of patients with HIV / AIDS that occurred in RSUD Gunung Jati Cirebon. This study involves 122 patients. Data were obtained from medical records and patient interview form. The data were evaluated with a descriptive analysis of demographic profile of patients and the percentage of adverse drug reaction (ADR The results showed an adverse drug reaction (ADR on the use of antiretroviral drugs in the treatment of patients with HIV / AIDS in RSUD Gunung Jati Cirebon. ARV regimens are the most widely used is the combination of Zidovudine + Lamivudine + Nevirapine / Efavirenz (AZT + 3TC + EFV as much as 31.2% (38 people. Duration of therapy ARV in Seroja Clinic RSUD Gunung Jati Cirebon most is> 2 years - 4 years 28.7% (35 people. Types of adverse drug reaction (ADR, which occurs in the use of antiretroviral drugs in the treatment of patients with HIV / AIDS in RSUD Gunung Jati Cirebon include: headache (22.1%, fatigue (6.8%, anemia (9.3%, itching (14.4%, nausea / vomiting (20.1%, diarrhea (7.2%, lipodystrophy (2.0%, rash (11.3%, skin discoloration (1.6%, neuropathy (1.6% and sleep disorders (3.6%.

  1. An exploratory factor analysis of the spontaneous reporting of severe cutaneous adverse reactions.

    Science.gov (United States)

    Hauben, Manfred; Hung, Eric; Hsieh, Wen-Yaw

    2017-01-01

    Severe cutaneous adverse reactions (SCARs) are prominent in pharmacovigilance (PhV). They have some commonalities such as nonimmediate nature and T-cell mediation and rare overlap syndromes have been documented, most commonly involving acute generalized exanthematous pustulosis (AGEP) and drug rash with eosinophilia and systemic symptoms (DRESS), and DRESS and toxic epidermal necrolysis (TEN). However, they display diverse clinical phenotypes and variations in specific T-cell immune response profiles, plus some specific genotype-phenotype associations. A question is whether causation of a given SCAR by a given drug supports causality of the same drug for other SCARs. If so, we might expect significant intercorrelations between SCARs with respect to overall drug-reporting patterns. SCARs with significant intercorrelations may reflect a unified underlying concept. We used exploratory factor analysis (EFA) on data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) to assess reporting intercorrelations between six SCARs [AGEP, DRESS, erythema multiforme (EM), Stevens-Johnson syndrome (SJS), TEN, exfoliative dermatitis (ExfolDerm)]. We screened the data using visual inspection of scatterplot matrices for problematic data patterns. We assessed factorability via Bartlett's test of sphericity, Kaiser-Myer-Olkin (KMO) statistic, initial estimates of communality and the anti-image correlation matrix. We extracted factors via principle axis factoring (PAF). The number of factors was determined by scree plot/Kaiser's rule. We also examined solutions with an additional factor. We applied various oblique rotations. We assessed the strength of the solution by percentage of variance explained, minimum number of factors loading per major factor, the magnitude of the communalities, loadings and crossloadings, and reproduced- and residual correlations. The data were generally adequate for factor analysis but the amount of variance explained

  2. An EAACI “European Survey on Adverse Systemic Reactions in Allergen Immunotherapy (EASSI)”: the methodology

    DEFF Research Database (Denmark)

    Calderón, Moises A; Rodríguez Del Río, Pablo; Vidal, Carmen

    2014-01-01

    and a "harmonised terminology" according to MedDRA, we aimed to prospectively collect systemic adverse reactions due to AIT from real life clinical settings. Under the framework of the EAACI, a team of European specialists in AIT, pharmacovigilance, epidemiology and drugs regulation set up a web-based prospective...

  3. The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals : A Retrospective Comparative Analysis

    NARCIS (Netherlands)

    Rolfes, Lean; van Hunsel, Florence; van der Linden, Laura; Taxis, Katja; van Puijenbroek, Eugene

    Introduction Clinical information is needed to assess the causal relationship between a drug and an adverse drug reaction (ADR) in a reliable way. Little is known about the level of relevant clinical information about the ADRs reported by patients. Objectives The aim was to determine to what extent

  4. Factors Influencing the Use of a Mobile App for Reporting Adverse Drug Reactions and Receiving Safety Information : A Qualitative Study

    NARCIS (Netherlands)

    de Vries, Sieta T.; Wong, Lisa; Sutcliffe, Alastair; Houyez, Francois; Ruiz, Carmen Lasheras; Mol, Peter G.M.

    Introduction A mobile app may increase the reporting of adverse drug reactions (ADRs) and improve the communication of new drug safety information. Factors that influence the use of an app for such two-way risk communication need to be considered at the development stage. Objective Our aim was to

  5. The twenty-third report on survey of the adverse reaction to radiopharmaceuticals (The 26th survey in 2000)

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2002-02-01

    The survey in the title involves occasions of adverse reactions and drug defects of radiopharmaceuticals and its 26th one in 2000 (April 1, 2000-March 31, 2001) is reported herein. The survey was conducted by questionnaire to 1,212 facilities, of which 1,044 (86.1%) answered. Adverse reaction (24 cases/1,401,962 in total cases of administration=0.0017% occasion) and drug defect (3 cases, 0.0002%) were reported from 25 facilities: They were 0.0017-0.0025% and 0.0001-0.0006%, respectively, after 1996. Most frequent occasion (203/100,000 examinations) of adverse reaction was seen in {sup 131}I-methyl-norcholesterol, which had been considered to be due to the ingredient, ethanol. Occasion of the adverse reaction of other drugs were less than 47/100,000 examinations. Three cases of the drug defect were poor distribution (2) ({sup 99m}Tc-HMDP) and poor labeling (1) ({sup 99m}Tc-tetrofosmin). (K.H.)

  6. Predisposing factors for adverse skin reactions with percutaneous bone anchored hearing devices implanted with skin reduction techniques.

    Science.gov (United States)

    Candreia, Claudia; Birrer, Ruth; Fistarol, Susanna; Kompis, Martin; Caversaccio, Marco; Arnold, Andreas; Stieger, Christof

    2016-12-01

    We present an analysis of adverse events after implantation of bone anchored hearing device in our patient population with focus on individual risk factors for peri-implant skin reactions. The investigation involved a chart review of adult Baha patients (n = 179) with 203 Bahas implanted with skin reduction techniques between 1993 and 2009, a questionnaire (n = 97) and a free clinical examination (n = 47). Skin reactions were graded by severity from 0 (no skin reaction) to 4 (implant loss resulting from infection) according to Holgers. We analyzed the skin reaction rate (SRR) defined as the number of skin reactions per year and the worst Holgers grade (WHG), which indicates the grade of the worst skin reaction per implant. We defined 20 parameters including the demographic characteristics, surgery details, subjective benefits, handling and individual factors. The most frequent adverse events (85 %) were skin reactions. The average SRR was 0.426 per Baha year. Six parameters showed an association with the SRR or the WHG. The clinically most relevant factors are an elevated Body Mass Index (BMI, p = 0.02) and darker skin type (p = 0.03). The SRR increased with the distance between the tragus and the implant (p = 0.02). Regarding the identified risk factors, the SRR might be reduced by selecting a location for the implant near the pinna and by specific counseling regarding post-operative care for patients with darker skin type or an elevated Body Mass Index (BMI). Few of the factors analyzed were found to influence the SRR and WHG. Since most adverse skin reactions could be treated easily with local therapy, our results suggest that in adult patients, individual risk factors for skin reactions are not a contraindication for Baha implantation. Thus, patients can be selected purely on audiological criteria.

  7. [Use of activated charcoal in acute poisonings: clinical safety and factors associated with adverse reactions in 575 cases].

    Science.gov (United States)

    Amigó, Montserrat; Nogué, Santiago; Miró, Oscar

    2010-07-17

    To identify the pattern of use of activated charcoal in the treatment of poisonings, and to evaluate the prevalence and severity of adverse reactions and define the risk factors associated with them. Observational, prospective 7-year study. Patients receiving activated charcoal for gut decontamination were included. Epidemiological, toxicological, therapeutic and evolutionary variables were studied. The dependent variable was the appearance of secondary effects related to the use of charcoal. A total of 575 patients were included. The mean age was 37.8 (14.8) years and 65.7% were women. Activated charcoal was administered orally in 88% of the patients and by gastric tube after lavage in 12%, and 2.4% of patients received charcoal before hospital arrival. Adverse reactions occurred in 41 cases (7.1%) and included nausea or vomiting (36 patients), bronchoaspiration (6 patients) and pneumonia (2 patients). Spontaneous vomiting before administration of charcoal (p < 0.001), pre-hospital administration of charcoal (p < 0.05), repeated doses (p < 0.01) and the need for symptomatic measures to treat intoxicated patients (p < 0.05) were independent risk factors for adverse reactions, whereas age ≥ 40 years (p < 0.05) and intoxication with benzodiazepines (p < 0.01) were independently associated with a smaller risk of adverse reactions. The mean emergency department stay was 10.2 (18.6) hours, and was significantly longer (p < 0.05) in patients suffering adverse reactions. A total of 75.4% of patients were discharged to home, 20.5% required psychiatric admission and 3.9% were admitted due to the clinical consequences of the poisoning. The prevalence of non-psychiatric admission to general hospital or intensive care was greater in patients suffering adverse reactions. No patient died. Adverse reactions to charcoal are infrequent and rarely severe, but are associated with a greater emergency department stay and a trend to greater hospital admission. Predisposing factors are

  8. Profile of rheumatology patients willing to report adverse drug reactions: bias from selective reporting

    Directory of Open Access Journals (Sweden)

    Protić D

    2016-02-01

    Full Text Available Dragana Protić,1 Nada Vujasinović-Stupar,2 Zoran Bukumirić,3 Slavica Pavlov-Dolijanović,4 Snežana Baltić,5 Slavica Mutavdžin,6 Ljiljana Markovic-Denić,7 Marija Zdravković,8 Zoran Todorović1 1Department of Pharmacology, Clinical Pharmacology and Toxicology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 2Department 2, Institute of Rheumatology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 3Institute for Medical Statistics and Informatics, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 4Department 5, Institute of Rheumatology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 5Department 5, Institute of Rheumatology, Belgrade, Serbia; 6Institute of Physiology “Rihard Burjan”, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 7Institute of Epidemiology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 8Department of Cardiology, Medical Center “Bežanijska kosa”, Faculty of Medicine, University of Belgrade, Belgrade, Serbia Background: Adverse drug reactions (ADRs have a significant impact on human health and health care costs. The aims of our study were to determine the profile of rheumatology patients willing to report ADRs and to identify bias in such a reporting system. Methods: Semi-intensive ADRs reporting system was used in our study. Patients willing to participate (N=261 completed the questionnaire designed for the purpose of the study at the hospital admission. They were subsequently classified into two groups according to their ability to identify whether they had experienced ADRs during the previous month. Group 1 included 214 out of 261 patients who were able to identify ADRs, and group 2 consisted of 43 out of 261 patients who were not able to identify ADRs in their recent medical history. Results: Group 1 patients were more significantly aware of their diagnosis than the patients from group 2. Marginal significance was found

  9. A Comparative Analysis Between Antibiotic- and Nonantibiotic-Associated Delayed Cutaneous Adverse Drug Reactions.

    Science.gov (United States)

    Trubiano, Jason A; Aung, Ar Kar; Nguyen, Mary; Fehily, Sasha R; Graudins, Linda; Cleland, Heather; Padiglione, Alex; Peleg, Anton Y

    The difference in clinical presentation, causality assessments, and outcomes of patients with delayed antibiotic-associated cutaneous adverse drug reactions (AA-cADR) and nonantibiotic-associated (NA)-cADR is ill defined. We examined the etiology of AA-cADR, with regard to the type of antibiotic exposure, allergy labeling, and patient outcomes, in comparison with NA-cADR. A retrospective observational inpatient cohort study of cADR was performed from January 2004 to August 2014. Patients were divided into AA-cADR and NA-cADR groups for analysis. cADR was defined as erythema multiforme, fixed drug eruption, acute generalized erythematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS), drug-associated linear IgA disease, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Of the 84 patients with cADR, 48% were AA-cADR. Male sex (60% vs 32%, P = .004), median length of stay (14.5 vs 11 days, P = .05), median Charlson comorbidity index (3 vs 1, P = .03), and inpatient mortality (20% vs 5%, P = .04) were higher in AA-cADR compared with NA-cADR. The median drug latency was lower in AA-cADR (6 vs 20 days, P = .001). Sulfonamide antibiotics and glycopeptides were implicated in 20% of AA-cADR. DRESS was more frequently reported in AA-cADR. After cADR diagnosis, further antibiotic therapy was administered in 64% of patients, higher in AA-cADR (75%, 30 of 40) compared with NA-cADR (55%, 24 of 44) (P = .06). Fluoroquinolones (53% vs 21%, P = .02), glycopeptides (vancomycin and teicoplanin; 70% vs 38%, P = .05), and carbapenems (33% vs 13%, P = .11) were used more commonly in AA-cADR. Antibiotics were the cause of cADR requiring hospital admission in 48% of episodes, and were associated with longer length of stay, higher age-adjusted Charlson comorbidity index, shorter drug latency, and mortality. In AA-cADR, glycopeptide and sulfonamide antibiotic exposure predominated. Copyright © 2016 American Academy of Allergy, Asthma & Immunology

  10. Healthcare professionals' awareness and knowledge of adverse drug reactions and pharmacovigilance.

    Science.gov (United States)

    Almandil, Noor B

    2016-12-01

    To document the knowledge of, attitudes toward, and practices of adverse drug reaction (ADR) reporting and pharmacovigilance systems among healthcare professionals. Methods: This descriptive cross-sectional study was conducted using a questionnaire. This study took place at King Fahd Hospital of the University (KFHU), Khobar, Kingdom of Saudi Arabia,  between  April 2015 and  April 2016. Healthcare professionals, including physicians, pharmacists, pharmacy technicians, and nurses, were considered eligible and invited to take part in the study. A link to the online questionnaire was sent to each participant via E-mail, and a hard copy was circulated at the hospital after the objectives of the study were explained. The questionnaire comprised items regarding knowledge/awareness of pharmacovigilance and ADRs, perception/attitude towards pharmacovigilance and ADR reporting, and practices of ADR reporting. Descriptive statistics were used to analyze the data. Results: A total of 400 questionnaires were distributed to the healthcare professionals and 331 participants responded, providing a response rate of 82.75%. The healthcare professionals comprised 161 physicians, 39 pharmacists, 21 pharmacist technicians, and 110 nurses. Most of the participants were female (n=198) and Saudi (61.9%). Most healthcare professionals (62.5%) were unaware of the term pharmacovigilance; the pharmacists and pharmacist technicians had the highest rate of pharmacovigilance awareness (60.5% of the pharmacists and 40% of pharmacist technicians). Conclusion: There is a lack of awareness and knowledge of pharmacovigilance and ADR reporting among healthcare professionals working at KFHU.

  11. The attitudes of pharmacists and physicians in Bosnia and Herzegovina towards adverse drug reaction reporting

    Directory of Open Access Journals (Sweden)

    Tarik Catic

    2016-04-01

    Full Text Available Introduction: Adverse drug reactions (ADRs are threat to the patient’s safety and the quality of life, and they increase the cost of health care. Spontaneous ADR reporting system mainly relies on physicians, but also pharmacists, nurses, and even patients. The aim of this study was to explore attitudes, barriers, and possible improvements to ADR reporting practices in Bosnia and Herzegovina.Methods: A self-reported questionnaire was developed to collect data on the perception of pharmacovigilance practice and ADR reporting. The survey was conducted in the period between September, 2014 and October, 2014.Results: The response rate was 73% (44 of 60 and 93% (148 of 160 among the pharmacist and family medicine physician groups, respectively. Regarding the attitudes to pharmacovigilance practice and reporting, both the pharmacists and physicians found the practices important. The majority of pharmacists and physicians in year 2014 did not report any ADR, while 18% of the pharmacists and 12% of the physicians, who participated in this study, reported one ADR. Reporting procedure, uncertainty, and their exposure were the main barriers to reporting ADRs for the pharmacists. The physicians claimed lack of knowledge to whom to report an ADR as the main barrier. A significant number of the respondents thought that additional education in ADR reporting would have a positive impact, and would increase the ADR reporting rate.Conclusions: Despite the overall positive attitude towards ADR reporting, the reporting rate in Bosnia and Herzegovina is still low. Different barriers to the ADR reporting have been identified, and there is also the need for improvements in the traditional education in this field.

  12. Survey to assess public awareness of patient reporting of adverse drug reactions in Great Britain.

    Science.gov (United States)

    Fortnum, H; Lee, A J; Rupnik, B; Avery, A

    2012-04-01

    Patient reporting to the Yellow Card Scheme (YCS) for reporting adverse drug reactions (ADR) has been available in the UK since 2005. By the end of 2009, 18% of the ADRs reported were submitted by patients. Thus, some patients are aware of the scheme, but we do not know how much awareness exists in the general population and hence the true impact of patient reporting. We added eight questions to a telephone omnibus survey of the adult population of the UK, administered over two weekends in January 2009. Results are based on 2028 completed interviews. Of respondents, 8·5% (n=172) had heard of the YCS, but only three individuals had self-reported to the scheme. People of a higher social grade and those with further education were significantly more likely to be aware of the YCS. Those who reported a preference for online reporting were more likely to be men, younger, of middle social grade with further education and in full-time employment. Those suggesting a preference for telephone reporting tended to be women, of working class and with a lower level of education, as did those who expressed a preference for postal reporting, but in addition they were more likely to be older and retired. Each of the three current methods of reporting was preferred by some respondents and could be continued. This is supported by reports that each of the three methods is currently used.   This first survey of awareness of the YCS in the general population of the UK indicates awareness is low and could be improved. © 2011 Blackwell Publishing Ltd.

  13. Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria.

    Science.gov (United States)

    Oshikoya, Kazeem A; Awobusuyi, Jacob O

    2009-08-11

    Spontaneous adverse drug reaction (ADR) reporting is the cornerstone of pharmacovigilance. ADR reporting with Yellow Cards has tremendously improved pharmacovigilance of drugs in many developed countries and its use is advocated by the World Health Organization (WHO). This study was aimed at investigating the knowledge and attitude of doctors in a teaching hospital in Lagos, Nigeria on spontaneous ADR reporting and to suggest possible ways of improving this method of reporting. A total of 120 doctors working at the Lagos State University Teaching Hospital (LASUTH), in Nigeria were evaluated with a questionnaire for their knowledge and attitudes to ADR reporting. The questionnaire sought the demographics of the doctors, their knowledge and attitudes to ADR reporting, the factors that they perceived may influence ADR reporting, and their levels of education and training on ADR reporting. Provision was also made for suggestions on the possible ways to improve ADR reporting. The response rate was 82.5%. A majority of the respondents (89, 89.9%) considered doctors as the most qualified health professionals to report ADRs. Forty (40.4%) of the respondents knew about the existence of National Pharmacovigilance Centre (NPC) in Nigeria. Thirty-two (32.3%) respondents were aware of the Yellow Card reporting scheme but only two had ever reported ADRs to the NPC. About half (48.5%) of the respondents felt that all serious ADRs could be identified after drug marketing. There was a significant difference between the proportion of respondents who felt that ADR reporting should be either compulsory or voluntary (chi2 = 38.9, P Education and training was the most recognised means of improving ADR reporting. The knowledge of ADRs and how to report them are inadequate among doctors working in a teaching hospital in Lagos, Nigeria. More awareness should be created on the Yellow Card reporting scheme. Continuous medical education, training and integration of ADR reporting into the

  14. Harvesting candidate genes responsible for serious adverse drug reactions from a chemical-protein interactome.

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    Lun Yang

    2009-07-01

    Full Text Available Identifying genetic factors responsible for serious adverse drug reaction (SADR is of critical importance to personalized medicine. However, genome-wide association studies are hampered due to the lack of case-control samples, and the selection of candidate genes is limited by the lack of understanding of the underlying mechanisms of SADRs. We hypothesize that drugs causing the same type of SADR might share a common mechanism by targeting unexpectedly the same SADR-mediating protein. Hence we propose an approach of identifying the common SADR-targets through constructing and mining an in silico chemical-protein interactome (CPI, a matrix of binding strengths among 162 drug molecules known to cause at least one type of SADR and 845 proteins. Drugs sharing the same SADR outcome were also found to possess similarities in their CPI profiles towards this 845 protein set. This methodology identified the candidate gene of sulfonamide-induced toxic epidermal necrolysis (TEN: all nine sulfonamides that cause TEN were found to bind strongly to MHC I (Cw*4, whereas none of the 17 control drugs that do not cause TEN were found to bind to it. Through an insight into the CPI, we found the Y116S substitution of MHC I (B*5703 enhances the unexpected binding of abacavir to its antigen presentation groove, which explains why B*5701, not B*5703, is the risk allele of abacavir-induced hypersensitivity. In conclusion, SADR targets and the patient-specific off-targets could be identified through a systematic investigation of the CPI, generating important hypotheses for prospective experimental validation of the candidate genes.

  15. Prevalence of unplanned hospitalizations caused by adverse drug reactions in older veterans.

    Science.gov (United States)

    Marcum, Zachary A; Amuan, Megan E; Hanlon, Joseph T; Aspinall, Sherrie L; Handler, Steven M; Ruby, Christine M; Pugh, Mary Jo V

    2012-01-01

    To describe the prevalence of unplanned hospitalizations caused by adverse drug reactions (ADRs) in older veterans and to examine the association between this outcome and polypharmacy after controlling for comorbidities and other patient characteristics. Retrospective cohort. Veterans Affairs Medical Centers. Six hundred seventy-eight randomly selected unplanned hospitalizations of older (aged ≥ 65) veterans between October 1, 2003, and September 30, 2006. Naranjo ADR algorithm, ADR preventability, and polypharmacy (0-4, 5-8, and ≥9 scheduled medications). Seventy ADRs involving 113 drugs were found in 68 (10%) hospitalizations of older veterans, of which 25 (36.8%) were preventable. Extrapolating to the population of more than 2.4 million older veterans receiving care during the study period, 8,000 hospitalizations may have been unnecessary. The most common ADRs that occurred were bradycardia (n = 6; beta-blockers, digoxin), hypoglycemia (n = 6; sulfonylureas, insulin), falls (n = 6; antidepressants, angiotensin-converting enzyme inhibitors), and mental status changes (n = 6; anticonvulsants, benzodiazepines). Overall, 44.8% of veterans took nine or more outpatient medications and 35.4% took five to eight. Using multivariable logistic regression and controlling for demographic, health-status, and access-to-care variables, polypharmacy (≥9 and 5-8) was associated with greater risk of ADR-related hospitalization (adjusted odds ratio (AOR) = 3.90, 95% confidence interval (CI) = 1.43-10.61 and AOR = 2.85, 95% CI = 1.03-7.85, respectively). ADRs, determined using a validated causality algorithm, are a common cause of unplanned hospitalization in older veterans, are frequently preventable, and are associated with polypharmacy. © 2011, Copyright the Authors Journal compilation © 2011, The American Geriatrics Society.

  16. Adverse drug reactions monitoring of psychotropic drugs: a tertiary care centre study

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    Hemendra Singh

    2017-06-01

    Full Text Available Background: Many new psychotropic drugs/ agents have been developed and found to be effective in the treatment of psychiatric disorders. However, these drugs also exhibit adverse drug reactions (ADRs which may affect compliance in psychiatric patients. Hence the present study was aimed at monitoring and assessing ADRs caused by psychotropic drugs. Methods: A hospital based prospective observational study was carried out in the psychiatry outpatient department of a tertiary care teaching hospital for the duration of six months. Two hundred and two patients were included in the study and ADRs were documented using a predesigned data collection form. The causality assessment was carried out as per the criteria of both the World Health Organization- Uppsala Monitoring Centre (WHO-UMC and Naranjo scale. Severity and predictability assessment of ADRs were also performed. Results: A total of 106 ADRs were observed during the study period with majority of them occurring in 25-35 years of age group (40.56%. Weight gain (18.86% followed by sedation (16.03% and insomnia (11.32% were found to be the commonest ADRs. Risperidone (19.8% and escitalopram (12.3% were the drugs responsible for majority of the ADRs. Causality assessment showed that most of ADRs were possible and probable. 94.33% of ADRs were found to be mild and 89% of them were predictable. Conclusion: A wide range of ADRs affecting central nervous and metabolic systems were reported with psychotropic drugs. The study findings necessitate the need for an active pharmacovigilance programme for the safe and effective use of psychotropics.

  17. IgE reactivity to hen egg white allergens in dogs with cutaneous adverse food reactions.

    Science.gov (United States)

    Shimakura, Hidekatsu; Uchiyama, Jumpei; Saito, Taku; Miyaji, Kazuki; Fujimura, Masato; Masuda, Kenichi; Okamoto, Noriaki; DeBoer, Douglas J; Sakaguchi, Masahiro

    2016-09-01

    Dogs with cutaneous adverse food reactions (CAFR) often have specific IgE to food allergens. Egg white, which is majorly composed of ovomucoid, ovalbumin, ovotransferrin, and lysozyme, is a food allergen in dogs. Information of the IgE reactivity to purified egg white allergens supports accurate diagnosis and efficiency treatment in humans. However, to the best of our knowledge, there have been no studies on the IgE reactivity to purified egg white allergens in dogs. Here, we investigated the IgE reactivity to crude and purified allergens of hen egg white in dogs with CAFR. First, when we examined serum samples from 82 dogs with CAFR for specific IgE to crude egg white by ELISA, 9.8% (8/82) of the dogs with CAFR showed the IgE reactivity to crude egg white. We then used sera from the eight dogs with positive IgE reactivity to crude egg white to examine the IgE reactivity to four purified allergens, ovomucoid, ovalbumin, ovotransferrin, and lysozyme, by ELISA. We found that 75% (6/8) of the dogs showed IgE reactivity to both ovomucoid and ovalbumin, and that 37.5% (3/8) of the dogs showed IgE reactivity to ovotransferrin. None (0/8) showed IgE reactivity to lysozyme. Moreover, validating these results, the immunoblot analyses were performed using the sera of the three dogs showing the highest IgE reactivity to crude egg white. Both anti-ovomucoid and anti-ovalbumin IgE were detected in the sera of these dogs, while anti-ovotransferrin IgE was not detected. Considering these, ovomucoid and ovalbumin appears to be the major egg white allergens in dogs with CAFR. Copyright © 2016 Elsevier B.V. All rights reserved.

  18. The Clinical Manifestations, Treatment Efficacy and Adverse Drug Reactions in 62 Iranian Child with Wilson Disease

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    Mehri Najafi

    2014-09-01

    Full Text Available Introduction: The Wilson disease is an autosomal recessive disease in which the liver, central nervous system, eyes, blood and other parts of the body involved. Timely diagnosis and appropriate treatment of the disease requires awareness of the clinical presentations of this disease in children.Methods: This case series study included 62 patients with Wilson disease who admitted to children's Medical Center in the years 2012-2003.Results: 56% of patients were male. The average age of diagnosis was 9.73 years old (5-17 years and this was higher in patients with early neurologic symptoms (P = 0.85.( 64.5% of the patients had the hepatic symptoms at the time of diagnosis and the most common type of hepatic involvement was cirrhosis (39.3% and hepatitis (17.5% respectively. 17.7% of the patients also had early neurological symptoms. A positive family history for the Wilson Disease were found in 27.4% of patients. 74.2% of patients had KF ring and the frequency of these symptom was higher in patients with early neurological involvement. 83.9% of patients were treated successfully with D-penicillamine and In 30% of patients, adverse drug reactions were seen.Conclusion: Children with unknown liver disease should be evaluated for Wilson disease and the first-degree relatives of patients should be screened. . D-penicillamine have important side effects, but due to the low cost and the availability is an appropriate drug to treat the Wilson disease..Key words: Wilson Disease, Hepatic Involvement, Neurologic Involvement , KF ring ,D-Penicillamine.

  19. An analysis of serious adverse drug reactions at a tertiary care teaching hospital

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    Kinjal Prajapati

    2016-01-01

    Full Text Available Objective: The objective of this study was to analyze the various aspects of serious adverse drug reactions (serious ADRs such as clinical presentation, causality, severity, and preventability occurring in a hospital setting. Materials and Methods: All serious ADRs reported from January 2010 to May 2015 at ADR Monitoring Centre, Department of Pharmacology, B. J. Medical College and Civil Hospital, Ahmedabad, were selected as per the World health Organization -Uppsala Monitoring Center (WHO-UMC criteria. A retrospective analysis was carried out for clinical presentation, causality (as per the WHO-UMC scale and Naranjo′s algorithm, severity (Hartwig and Siegel scale, and preventability (Schumock and Thornton criteria. Results: Out of 2977 ADRs reported, 375 were serious in nature. The most common clinical presentation involved was skin and appendageal disorders (71, 18.9%. The common causal drug group was antitubercular (129, 34.4% followed by antiretroviral (76, 20.3% agents. The criteria for the majority of serious ADRs were intervention to prevent permanent impairment or damage (164, 43.7% followed by hospitalization (158, 42.1%. Majority of the serious ADRs were continuing (191, 50.9% at the time of reporting, few recovered (101, 26.9%, and two were fatal. The majority of serious ADRs were categorized as possible (182, 48.8% followed by probable (173, 46.1% in nature. Conclusion: Antitubercular, antiretroviral, and antimicrobial drugs were the most common causal drug groups for serious ADRs. This calls for robust ADR monitoring system and education of patients and prescribers for identification and effective management.

  20. Adverse Drug Reactions in Hospitalized Pediatric Patients: A Prospective Observational Study.

    Science.gov (United States)

    Kurian, J; Mathew, J; Sowjanya, K; Chaitanya, K R K; Ramesh, M; Sebastian, J; Narayanappa, D

    2016-05-01

    To determine the incidence, pattern, causality, preventability, severity and predictors of adverse drug reactions (ADRs) in pediatric population. It was a prospective, observational study that included patients of either sex, of any age treated in the pediatric wards of a tertiary care hospital. Study patients were followed throughout their hospital stay. Whenever an ADR was detected, all the required data was collected and analyzed. Data was analyzed for incidence, causality (by using WHO Probability scale and Naranjo's algorithm), preventability (by using Modified Shumock and Thornton scale), severity (by using Modified Hartwig and Siegel scale) and predictors of ADRs. Of the 1775 children admitted in the pediatrics ward, 1082 patients met study criteria and were enrolled into the study. A total of 64 ADRs were identified from 54 patients. The incidence of ADRs was 4.99 %. Male patients experienced majority (68.52 %) of ADRs. Drugs most commonly implicated in ADRs were amoxicillin + clavulanate (21.87 %) followed by ceftriaxone (20.31 %). Most (51.56 %) of the ADRs reported belonged to the system organ class, gastrointestinal system disorders. Among the ADRs reported, 82.85 % of ADRs were mild. Majority (87.5 %) of the ADRs were of 'probable' causality category and 96.9 % were not preventable. There was a significant association between occurrence of ADRs and the use of ≥4 number of medications, age (infants) and gender (male). Among the pediatric population, infants, male gender and those receiving ≥4 number of medications are at risk of developing ADRs. Constant monitoring is required to address the safety issue in pediatric population especially in infants and patients receiving ≥4 drugs.

  1. Provocation proven drug allergy in Thai children with adverse drug reactions.

    Science.gov (United States)

    Indradat, Somying; Veskitkul, Jittima; Pacharn, Punchama; Jirapongsananuruk, Orathai; Visitsunthorn, Nualanong

    2016-03-01

    Adverse drug reactions (ADRs) are a common healthcare problem. The drug provocation test (DPT) is a gold standard for ADR diagnosis. To evaluate a correlation between history of ADRs, skin prick test (SPT), intradermal test (ID) and DPT in Thai children. This was a retrospective review of 211 children under 16 years of age who had a history of ADRs and underwent DPT from January 2006 to December 2012. Two hundred and thirty six (236) DPTs were performed in 211 children with a history of ADRs. The median age at which DPTs were performed was 4 years. Thirty-four children (14.4%) had positive DPT. The positive predictive value (PPV), negative predictive value (NPV), sensitivity, specificity, likelihood ratio (LR) + and LR- of SPT were 50, 85.7, 6.9, 98.8%, 5.8 and 0.9, respectively. The PPV, NPV, sensitivity, specificity, LR+ and LR- of ID were 33.3, 84.6, 20, 91.7%, 2.4 and 0.9, respectively. Different presentation of symptoms (maculopapular rashes, urticaria, angioedema and anaphylaxis) did not predict SPT, ID and DPT results. Positive human immunodeficiency virus (HIV), but not atopy, was a risk in the present scope of evaluation for drug allergy (odds ratio 11.44, 95% confidence interval 2.60-50.41). Drug allergy, denoted by positive DPT, was present in 14.4% of Thai children with a history of ADRs. Antibiotics were the most common cause of ADRs. Both SPT and ID had high NPV and specificity but did not predict DPT results. HIV positivity is a risk factor of drug allergy in Thai children.

  2. Deep learning for pharmacovigilance: recurrent neural network architectures for labeling adverse drug reactions in Twitter posts.

    Science.gov (United States)

    Cocos, Anne; Fiks, Alexander G; Masino, Aaron J

    2017-07-01

    Social media is an important pharmacovigilance data source for adverse drug reaction (ADR) identification. Human review of social media data is infeasible due to data quantity, thus natural language processing techniques are necessary. Social media includes informal vocabulary and irregular grammar, which challenge natural language processing methods. Our objective is to develop a scalable, deep-learning approach that exceeds state-of-the-art ADR detection performance in social media. We developed a recurrent neural network (RNN) model that labels words in an input sequence with ADR membership tags. The only input features are word-embedding vectors, which can be formed through task-independent pretraining or during ADR detection training. Our best-performing RNN model used pretrained word embeddings created from a large, non-domain-specific Twitter dataset. It achieved an approximate match F-measure of 0.755 for ADR identification on the dataset, compared to 0.631 for a baseline lexicon system and 0.65 for the state-of-the-art conditional random field model. Feature analysis indicated that semantic information in pretrained word embeddings boosted sensitivity and, combined with contextual awareness captured in the RNN, precision. Our model required no task-specific feature engineering, suggesting generalizability to additional sequence-labeling tasks. Learning curve analysis showed that our model reached optimal performance with fewer training examples than the other models. ADR detection performance in social media is significantly improved by using a contextually aware model and word embeddings formed from large, unlabeled datasets. The approach reduces manual data-labeling requirements and is scalable to large social media datasets.

  3. Knowledge, Attitude and Practice of Adverse Drug Reactions Reporting Among Healthcare Professionals

    Directory of Open Access Journals (Sweden)

    Siddeshwara M.G.

    2016-01-01

    Full Text Available Objectives:  This study was conducted to evaluate knowledge, attitude and practice of Adverse Drug Reactions (ADR reporting among Healthcare Professionals.Methods: A cross-sectional study was done by survey using questionnaire. Questionnaire was distributed to 260 healthcare professionals working at M.R. Medical College and S Nijalingappa Institute of Dental Sciences, Kalaburagi, India.Results: Out 260 people 221 provided the response, giving a response rate of 85%. Among respondents 69.68% were Doctors, 23.53% were Nurses and 6.78% were Pharmacists. 71% of the healthcare professionals knew what are ADRs, 62.4% knew what is pharmacovigilance, 35.7% were aware of Pharmacovigilance Programme of India (PvPI and 21.7% knew nearest pharmacovigilance center. 50.2% had seen patients experiencing ADR out of which only 8.1% of them have reported ADR to the concerned unit. 72.4% feel that all the cases of ADR should be reported irrespective of seriousness. Concern that report may be wrong and fear of legal liability were the main factors discouraging them for reporting ADR. Local coordination, Financial Support, ADR reporting awareness programmes were the major expectations from respondents.Conclusion: Healthcare professionals working at HKE Society’s M.R. Medical College and S Nijalingappa Institute of Dental Sciences have positive attitudes towards ADR reporting. However knowledge regarding ADR reporting among Doctors is superior to that of Nurses and Pharmacists, awareness programmes can overcome this problem. But the practice of ADR reporting is poor among all Healthcare professionals.

  4. Adverse Drug Reactions for Medicines Newly Approved in Japan from 1999 to 2013: Hypertension and Hypotension.

    Science.gov (United States)

    Nagayama, Takashi; Nishida, Minoru; Hizue, Masanori; Ogino, Yamato; Fujiyoshi, Masato

    2016-04-01

    In this survey, the correlation between adverse drug reactions (ADRs) in human and animal toxicities was investigated for 393 medicines which were approved in Japan from September 1999 to March 2013. ADRs were collected from each Japanese package insert. Comparable animal toxicities with ADRs were collected by thorough investigation of common technical documents. The results of this survey show that hypertension and/or hypotension were mainly observed in medicines affecting the central nervous system. Hypertension was also observed in antipyretics, analgesics, anti-inflammatory agents, vasoconstrictors and agents using antibody. Concordance between human ADRs and animal toxicities was analysed. True-positive rate for hypertension and hypotension is 0.29 and 0.52, respectively. Positive likelihood ratio and inverse negative likelihood ratio are 1.98 and 1.21, respectively, in hypertension and 1.67 and 1.44, respectively, in hypotension. Concordance between human ADRs and animal toxicities is not so high in hypertension and hypotension. Identified mechanisms as on-target for hypertension and hypotension are 29.8% and 30.5%, respectively. More than half of the causative factors of hypertension and hypotension were unable to be elucidated. Our results show that the intake of medicines is often linked to blood pressure variations that are not predicted in animal toxicity studies. Improvement of drug development processes may be necessary to provide safer medicines because current animal toxicity studies are insufficient to predict all ADRs in human beings. © 2015 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).

  5. Flow Microscopy Imaging Is Sensitive to Characteristics of Subvisible Particles in Peginesatide Formulations Associated With Severe Adverse Reactions.

    Science.gov (United States)

    Daniels, Austin L; Randolph, Theodore W

    2018-02-01

    The presence of subvisible particles in formulations of therapeutic proteins is a risk factor for adverse immune responses. Although the immunogenic potential of particulate contaminants likely depends on particle structural characteristics (e.g., composition, size, and shape), exact structure-immunogenicity relationships are unknown. Images recorded by flow imaging microscopy reflect information about particle morphology, but flow microscopy is typically used to determine only particle size distributions, neglecting information on particle morphological features that may be immunologically relevant. We recently developed computational techniques that utilize the Kullback-Leibler divergence and multidimensional scaling to compare the morphological properties of particles in sets of flow microscopy images. In the current work, we combined these techniques with expectation maximization cluster analyses and used them to compare flow imaging microscopy data sets that had been collected by the U.S. Food and Drug Administration after severe adverse drug reactions (including 7 fatalities) were observed in patients who had been administered some lots of peginesatide formulations. Flow microscopy images of particle populations found in the peginesatide lots associated with severe adverse reactions in patients were readily distinguishable from images of particles in lots where severe adverse reactions did not occur. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  6. Patterns of Adverse Transfusion Reactions in a Tertiary Care Centre of North India: A Step Towards Hemovigilance.

    Science.gov (United States)

    Bassi, Rajni; Aggarwal, Shikha; Bhardwaj, Kanchan; Thakur, Kusum K

    2017-06-01

    Transfusion of blood and blood products is a double edged sword, so it should be used judiciously. The primary aim of the centralized Haemovigilance Program is to improve transfusion safety. To determine the incidence of adverse transfusion reactions (ATRs) in recipients of blood and blood components. Prospective study from January 2014 till April 2015 was done. ATRs reported to the Department of Transfusion Medicine were recorded and analyzed on the basis of their clinical features and lab tests. During the study period 25,099 units of blood and blood components were transfused and 100 ATRs (0.40 %) were reported. The incidence of febrile nonhemolytic transfusion reactions (FNHTR) was maximum (73 %) followed by allergic reactions (24 %), bacterial sepsis (1 %), hypotension due to ACE inhibitors (1 %) and acute hemolytic transfusion reaction (AHTR) (1 %). Of all the reported ATRs, 76 % occurred with packed red cells, 15 % occurred with whole blood, while platelets and Fresh Frozen Plasma transfusions were responsible for 8 % and 1 %, respectively. The majority of the reactions were FNHTRs followed by allergic reactions. Reporting of all adverse events and continuous medical education to medical and paramedical staff will help in strengthening hemovigilance system.

  7. A systematic review of the evidence of reduced allergenicity and clinical benefit of food hydrolysates in dogs with cutaneous adverse food reactions.

    Science.gov (United States)

    Olivry, Thierry; Bizikova, Petra

    2010-02-01

    Several hydrolysate-based diets have been commercialized for helping diagnose or treat dogs with cutaneous adverse food reactions (CAFR). This systematic review was performed to examine the evidence in favour of reduced immunological and clinical allergenicity of hydrolysates in dogs with CAFR. Citation databases, meeting abstracts and article bibliographies were scanned for relevant citations, and companies were contacted to provide unpublished reports. Eleven studies relevant to this study were identified. Some evidence of reduced serum IgE binding to a soy hydrolysate (1 study) and decreased intradermal test reactivity to hydrolysed proteins (three studies) was found. In four reports, the feeding of dogs suspected of having CAFR with hydrolysate-based diets reduced or eliminated clinical signs in a variable proportion of subjects. The percentage of dogs with CAFR that still reacted to these hydrolysate-based diets could not be assessed, however. Importantly, up to 50% of dogs with CAFR enrolled in three controlled studies exhibited increases in clinical signs after ingesting partial hydrolysates derived from foods to which they were hypersensitive. In conclusion, the limited number of studies undertaken point to reduced - but not eliminated - immunological and clinical allergenicity of hydrolysate-based commercial diets. A variable proportion of dogs with CAFR will exhibit a worsening of clinical signs when fed partial hydrolysates. Clinicians must weigh the clinical benefit of these diets versus their high cost and low risk of reduced appetence or gastrointestinal sign development. At this time, hydrolysate-containing diets are probably best used in dogs suspected not to be hypersensitive to their individual components.

  8. Campania Preventability Assessment Committee (Italy: A Focus on the Preventability of Non-steroidal Anti-inflammatory Drugs' Adverse Drug Reactions

    Directory of Open Access Journals (Sweden)

    Maurizio Sessa

    2017-05-01

    Full Text Available Purpose: This study aims to investigate preventability criteria of adverse drug reactions (ADRs involving non-steroidal anti-inflammatory drugs (NSAIDs by analyzing individual case safety reports (ICSRs sent through Campania region (Italy spontaneous reporting system from July 2012 to October 2016.Methods: For all the ICSRs that reported NSAIDs as suspected drug, a trained multidisciplinary team of Campania Pharmacovigilance Regional Centre composed of clinical pharmacologists and pharmacists with pluriannual experience in Pharmacovigilance assessed preventability by using the P-method.Results: In all 19,039 ICSRs were sent to Campania Pharmacovigilance Regional Centre, of which 550 reported NSAIDs as suspected drug. In total, 94 cases (17.1% out of 550 ICSRs were preventable. In the 94 preventable cases, 201 critical criteria were detected of which 182/201 (90.5% related to healthcare professionals' practices, 0/201 (0.0% to drug quality, and 19/201 (9.5% to patient behavior. The most detected critical criteria were the necessary medication not given (52/182; 28.6%, labeled drug–drug interaction (36/182; 19.7%, incorrect drug administration duration (31/182; 16.9%, wrong indication (26/182; 14.2%, therapeutic duplication (18/182; 10.0%, and documented hypersensitivity to administered drug or drug class (10/182; 5.6%. In seventeen (18.1% preventable cases, there were 19 critical criteria involving non-compliance (15/19 critical criteria; 78.9% and self-medication with the non-over-the-counter drugs (4/19 critical criteria; 21.1%. In all, 17 out 94 (18.1% preventable cases involved over-the-counter drugs.Conclusion: A call for action for Campania Pharmacovigilance Regional Centre is necessary in order to promote initiatives to increase the awareness of healthcare professionals and citizens on the risk associated with inappropriate use of NSAIDs.

  9. Adverse reactions from community directed treatment with ivermectin (CDTI for onchocerciasis and loiasis in Ondo State, Nigeria

    Directory of Open Access Journals (Sweden)

    O.A Otubanjo

    2008-12-01

    Full Text Available Onchocerciasis is an endemic disease in Ondo state, Nigeria. Community directed distribution of ivermectin is currently on-going in some local government areas of the state. Randomly selected persons (2 331 males and 2 469 females were interviewed using a modified rapid assessment procedure for Loa loa (RAPLOA to assess community directed treatment with ivermectin. The retrospective study evaluated the coverage, impacts and adverse reactions to the drug treatment. A questionnaire was administered by house-to-house visit in six local government areas, implementing community directed treatment with ivermectin (CDTI in this bioclimatic zone. A total of 2,398 respondents were reported to have participated in the treatment. The overall ivermectin coverage of 49.96% was recorded (range 0 - 52% in different communities. Adverse reactions from ivermectin administration were experienced in 38% of individuals. Diverse adverse reactions experienced included predominantly itching (18.50%; oedema, especially of the face and the limbs (8.2%; rashes (3.4% and body weakness (2.4%. Expulsion of intestinal worms occurred in 0.96% of the respondents. The occurrence of adverse reactions in relation to age categories was statistically significant. Neither fatal nor severe adverse reactions were reported by respondents. Significantly, despite experienced adverse reactions, continued participation, acceptability and compliance to ivermectin treatment was expressed by the various communities. This attitude is in consonance with the African Programme for Onchocerciasis Control (APOC objectives. Rev. Biol. Trop. 56 (4: 1635-1643. Epub 2008 December 12.La oncocercosis es endémica en el estado Ondo, Nigeria. Se seleccionaron 4 800 personas al azar para evaluar con encuesta retrospectiva la cobertura, efectos y reacciones al tratamiento farmacológico con ivermectina administrado por la misma comunidad. La cobertura global de ivermectina fue 50 % con reacciones adversas en

  10. Spooky Suspects

    Science.gov (United States)

    Pacifici, Lara

    2011-01-01

    This activity presents an option for covering biology content while engaging students in an investigation that highlights the spirit of Halloween. Students are engaged in the story line and have fun trying to solve the mystery kidnapping by using science skills to examine the evidence and eliminate some ghoulish suspects. (Contains 1 figure.)

  11. Portable automatic text classification for adverse drug reaction detection via multi-corpus training.

    Science.gov (United States)

    Sarker, Abeed; Gonzalez, Graciela

    2015-02-01

    Automatic detection of adverse drug reaction (ADR) mentions from text has recently received significant interest in pharmacovigilance research. Current research focuses on various sources of text-based information, including social media-where enormous amounts of user posted data is available, which have the potential for use in pharmacovigilance if collected and filtered accurately. The aims of this study are: (i) to explore natural language processing (NLP) approaches for generating useful features from text, and utilizing them in optimized machine learning algorithms for automatic classification of ADR assertive text segments; (ii) to present two data sets that we prepared for the task of ADR detection from user posted internet data; and (iii) to investigate if combining training data from distinct corpora can improve automatic classification accuracies. One of our three data sets contains annotated sentences from clinical reports, and the two other data sets, built in-house, consist of annotated posts from social media. Our text classification approach relies on generating a large set of features, representing semantic properties (e.g., sentiment, polarity, and topic), from short text nuggets. Importantly, using our expanded feature sets, we combine training data from different corpora in attempts to boost classification accuracies. Our feature-rich classification approach performs significantly better than previously published approaches with ADR class F-scores of 0.812 (previously reported best: 0.770), 0.538 and 0.678 for the three data sets. Combining training data from multiple compatible corpora further improves the ADR F-scores for the in-house data sets to 0.597 (improvement of 5.9 units) and 0.704 (improvement of 2.6 units) respectively. Our research results indicate that using advanced NLP techniques for generating information rich features from text can significantly improve classification accuracies over existing benchmarks. Our experiments

  12. Do Health Professionals have Positive Perception Towards Consumer Reporting of Adverse Drug Reactions?

    Science.gov (United States)

    Alshakka, Mohammed Ahmed; Ibrahim, Mohamed Izham Mohamed; Hassali, Mohamed Azmi Ahmad

    2013-10-01

    The aim of this study was to evaluate the perceptions of general practitioners (GPs) and community pharmacists (CPs) in Penang, Malaysia, towards consumer reporting of Adverse Drug Reactions (ADRs). A cross-sectional mail survey was adopted for the performance of the study. Survey questionnaires were sent to 192 CPs and 400 GPs in the state of Penang, Malaysia. Reminders were sent to all the non-respondents after 3 weeks of the initial mailing. Data which were collected from the questionnaires were analyzed by using the Statistical Package for Social Science (SPSS), version 15. The Chi-square test was used to determine as to whether there was any significant difference between expected and observed frequencies at the alpha level of 0.05. Only 104 respondents (47 CPs and 57 GPs) returned the survey, with a response rate of 18.0%- a figure which could be considered to be low. This study indicated that GPs and CPs were aware about the importance and benefits of consumer reporting. A majority of them (88.0%) thought that consumer reporting would add more benefits to the existing pharmacovigilance program. Similarly, 97% of the respondents agreed that reporting of ADRs was necessary and 87.0% respondents had seen ADRs among their patients. However, 57 of them (6.0%), had not been aware that the national program in Malaysia allowed consumers to report ADRs. A majority of them (97.0%) agreed that consumers needed more education regarding ADR reporting. Most of them (84.0%) thought that consumers could not write valid reports which were similar to reports which were made by healthcare professionals (HCPs). A majority of the respondents (68.0%) had not heard about the consumer reporting program in Malaysia and half of them did not believe that consumer reporting could overcome under-reporting, which was the main problem of the national pharmacovigilance program in Malaysia. The GPs and CPs were aware about the importance and benefits of consumer reporting. Such reporting

  13. Do Health Professionals have Positive Perception Towards Consumer Reporting of Adverse Drug Reactions?

    Science.gov (United States)

    Alshakka, Mohammed Ahmed; Ibrahim, Mohamed Izham Mohamed; Hassali, Mohamed Azmi Ahmad

    2013-01-01

    Aim: The aim of this study was to evaluate the perceptions of general practitioners (GPs) and community pharmacists (CPs) in Penang, Malaysia, towards consumer reporting of Adverse Drug Reactions (ADRs). Methodology: A cross-sectional mail survey was adopted for the performance of the study. Survey questionnaires were sent to 192 CPs and 400 GPs in the state of Penang, Malaysia. Reminders were sent to all the non-respondents after 3 weeks of the initial mailing. Data which were collected from the questionnaires were analyzed by using the Statistical Package for Social Science (SPSS), version 15. The Chi-square test was used to determine as to whether there was any significant difference between expected and observed frequencies at the alpha level of 0.05. Results: Only 104 respondents (47 CPs and 57 GPs) returned the survey, with a response rate of 18.0%- a figure which could be considered to be low. This study indicated that GPs and CPs were aware about the importance and benefits of consumer reporting. A majority of them (88.0%) thought that consumer reporting would add more benefits to the existing pharmacovigilance program. Similarly, 97% of the respondents agreed that reporting of ADRs was necessary and 87.0% respondents had seen ADRs among their patients. However, 57 of them (6.0%), had not been aware that the national program in Malaysia allowed consumers to report ADRs. A majority of them (97.0%) agreed that consumers needed more education regarding ADR reporting. Most of them (84.0%) thought that consumers could not write valid reports which were similar to reports which were made by healthcare professionals (HCPs). A majority of the respondents (68.0%) had not heard about the consumer reporting program in Malaysia and half of them did not believe that consumer reporting could overcome under-reporting, which was the main problem of the national pharmacovigilance program in Malaysia. Conclusion: The GPs and CPs were aware about the importance and benefits

  14. Adverse Drug Reaction Identification and Extraction in Social Media: A Scoping Review.

    Science.gov (United States)

    Lardon, Jérémy; Abdellaoui, Redhouane; Bellet, Florelle; Asfari, Hadyl; Souvignet, Julien; Texier, Nathalie; Jaulent, Marie-Christine; Beyens, Marie-Noëlle; Burgun, Anita; Bousquet, Cédric

    2015-07-10

    The underreporting of adverse drug reactions (ADRs) through traditional reporting channels is a limitation in the efficiency of the current pharmacovigilance system. Patients' experiences with drugs that they report on social media represent a new source of data that may have some value in postmarketing safety surveillance. A scoping review was undertaken to explore the breadth of evidence about the use of social media as a new source of knowledge for pharmacovigilance. Daubt et al's recommendations for scoping reviews were followed. The research questions were as follows: How can social media be used as a data source for postmarketing drug surveillance? What are the available methods for extracting data? What are the different ways to use these data? We queried PubMed, Embase, and Google Scholar to extract relevant articles that were published before June 2014 and with no lower date limit. Two pairs of reviewers independently screened the selected studies and proposed two themes of review: manual ADR identification (theme 1) and automated ADR extraction from social media (theme 2). Descriptive characteristics were collected from the publications to create a database for themes 1 and 2. Of the 1032 citations from PubMed and Embase, 11 were relevant to the research question. An additional 13 citations were added after further research on the Internet and in reference lists. Themes 1 and 2 explored 11 and 13 articles, respectively. Ways of approaching the use of social media as a pharmacovigilance data source were identified. This scoping review noted multiple methods for identifying target data, extracting them, and evaluating the quality of medical information from social media. It also showed some remaining gaps in the field. Studies related to the identification theme usually failed to accurately assess the completeness, quality, and reliability of the data that were analyzed from social media. Regarding extraction, no study proposed a generic approach to easily

  15. Diagnostic Tools to Use When We Suspect an Allergic Reaction to a Tattoo: A Proposal Based on Cases at Our Hospital.

    Science.gov (United States)

    González-Villanueva, I; Silvestre Salvador, J F

    2017-12-06

    Tattooing has become a popular practice in western countries, particularly among younger populations. Tattoos, however, can cause complications, such as infections, allergic or foreign-body reactions, and even systemic inflammatory responses. We conducted a retrospective study of all patients seen for tattoo-related complications at our skin allergy unit between January 2002 and December 2016. We studied 23 patients. Nine of these experienced early complications, all related to infection. The other 14 patients developed late reactions. Ten were diagnosed with probable allergic contact dermatitis to ink, but the suspect allergen was identified in just 3 cases and confirmed in just 1 of these. There were 2 cases of cutaneous sarcoidosis, 1 case of foreign body granuloma, and 1 case of neuropathy. Complications resulting from tattoos are relatively common dermatology complaints. Drawing from our experience, we propose a diagnostic algorithm designed to guide dermatologists in evaluating different reactions to tattoos and prescribing appropriate treatment. Copyright © 2017 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.

  16. Apheresis platelets are more frequently associated with adverse reactions than pooled platelets both in recipients and in donors: a study from French hemovigilance data.

    Science.gov (United States)

    Daurat, Aurélien; Roger, Claire; Gris, JeanChristophe; Daurat, Gérald; Feissel, Michel; Le Manach, Yannick; Lefrant, JeanYves; Muller, Laurent

    2016-06-01

    Controversy exists regarding the safety of the different types of platelet (PLT) concentrates. This study was aimed at comparing the rate of adverse reactions associated with apheresis PLT concentrates (APCs) and pooled PLT concentrates (PPCs) both in donors and in recipients. From the French national hemovigilance system, types and numbers of recipient adverse reactions were compared over a period from 2009 to 2011. Donor adverse reactions were available for 2010 and 2011. This study involved 23 of 26 French regions. Main outcomes were the rates of adverse reaction in recipients and serious adverse reaction in donors. There were 790,854 PLT transfusions during the study period (477,747 [60%] with APCs, 313,107 [40%] with PPCs). APCs were associated with more adverse reactions (6244 vs. 2469 per 1,000,000, p reactions (respectively, 241 vs. 131 per 1,000,000, p adverse transfusion reaction were similar (15 vs. 6 per 1,000,000, p = 0.5). In donors, the number of whole blood (WB) donations was 4,722,685 whereas 266,095 apheresis procedures were performed. Serious adverse reactions were more frequent for apheresis procedures than for WB donations (5445 vs. 803 per 1,000,000, p donors. This study calls for randomized trials to confirm or refute these results. © 2016 AABB.

  17. Reporting adverse transfusion reactions: A retrospective study from tertiary care hospital from New Delhi, India

    Directory of Open Access Journals (Sweden)

    Sangeeta Pahuja

    2017-01-01

    Conclusions: Awareness should be increased among clinicians to correctly prevent, identify, and report transfusion-related adverse events. These measures should be implemented to increase blood transfusion quality and safety.

  18. Reactions to adverse incidents in the health services on Twitter: a mixed methods study

    OpenAIRE

    Sarah Meaney; Leanne Cussen

    2015-01-01

    Background: Participation in social networking is commonplace and social media is transforming both health and health related research. Of the various social media platforms, Twitter must be considered a platform for rapid and immediate communication. There has been considerable national and international media coverage reporting a number of adverse incidents in the Irish maternity services. The media coverage of these adverse incidents, most recently about a cluster of perinatal deaths, st...

  19. Identifying and managing an adverse food reaction in a polar bear (Ursus maritimus) by an elimination diet trial.

    Science.gov (United States)

    Monson, Sara; Minter, Larry J; Krouse, Marissa; De Voe, Ryan S

    2014-06-01

    A 16-yr-old polar bear (Ursus maritimus) presented with severe diarrhea shortly following transfer to the North Carolina Zoological Park. Multiple diagnostic procedures were performed over several months and the cause of the chronic diarrhea was inconclusive. Histologically, colonic mucosal biopsies were consistent with severe chronic eosinophilic and lymphoplasmacytic colitis with no evidence of etiologic agents present. A dietary elimination trial was conducted and an adverse food reaction to the dog chow in the diet was confirmed.

  20. Drug-induced cutaneous adverse drug reactions in dermatology in Dr. B.R. Ambedkar Medical College

    OpenAIRE

    C. Kumari Bai; L. Padma; N T Madan Mohan; D. R. Veena

    2014-01-01

    Background: Cutaneous adverse drug reactions (ADRs) affect 2-3% of hospitalized patients. The severity varies from mild itching to life-threatening Stevens-Johnson syndrome (SJS). Hence, this study was undertaken to emphasize the need to report ADRs. Methods: The study was carried out in the Department of Dermatology in Dr. B.R Ambedkar Medical College Hospital from June to December 2012. Naranjo's algorithm was used to determine the causality of an ADR. Informed consent was obtained from ...

  1. Analysis of potential drug interactions and adverse reactions to nonsteroidal anti-inflammatory drugs among the elderly

    OpenAIRE

    Lima,Tiago Aparecido Maschio de; Furini,Adriana Antônia da Cruz; Atique,Tábata Salum Calille; Di Done,Patricia; Machado,Ricardo Luiz Dantas; Godoy,Moacir Fernandes de

    2016-01-01

    Abstract Objective: The aim of the present study was to analyze potential drug interactions and adverse reactions to NSAIDs in elderly users of a private drug distribution service. Method: A prospective, exploratory and descriptive study with a quantitative approach was performed. The elderly users of NSAIDs attended by the service were interviewed and their prescriptions analyzed between May and September, 2014. Analysis of drug interactions was performed through computerized databases. ...

  2. A prospective study on adverse drug reactions in outpatients and inpatients of medicine department in a tertiary care hospital

    OpenAIRE

    Harsha Ramakrishnaiah; Vasundara Krishnaiah; H. P. Pundarikaksha; Vedavathi Ramakrishna

    2015-01-01

    Background: No pharmacotherapeutic agent is completely free from noxious and unintended effects and thus adverse drug reactions (ADRs) are inevitable consequences of drug therapy. Incidence of ADRs in Indian population ranges between 1.8% and 25.1%. However, ADR reporting in India is inadequate. Developing awareness inpatients and healthcare professionals (HCPs) will help in reducing the ADRs, its suffering and socioeconomic impact. Hence, the present study of ADR monitoring in the outpatient...

  3. A Retrospective Analysis of Apheresis Donor Deferral and Adverse Reactions at a Tertiary Care Centre in India.

    Science.gov (United States)

    Arora, Disha; Garg, Ketan; Kaushik, Ankit; Sharma, Richa; Rawat, D S; Mandal, A K

    2016-11-01

    With increasing demand of platelet component each day, blood bank plays a pivotal role in ensuring supply of safe blood as and when required. Plateletpheresis procedure is a relatively simple, safe and important adjunct to blood bank inventory. However, recruitment of healthy blood donors is a challenge that the health industry is facing today. To determine the reasons and rates of apheresis donor deferral along with investigation of adverse reactions encountered during the procedure. Records of single donor apheresis were retrospectively analysed from 1st January 2010 to 31st December 2014. The study was carried out at Blood Bank, Safdarjung Hospital, New Delhi, India. The donor details that were studied included - age, sex, type of donation (voluntary/replacement/ repeat), reason for donor deferral and type of adverse reaction, if encountered during the procedure. Among the 478 donors screened for plateletpheresis procedure during a study period of 5 years, 134 (28.03%) were deferred. Temporary deferrals accounted for majority (93.28%) of the deferrals. Low platelet count (50.75%) was the main reason of donor deferral followed by low haemoglobin (20.89%). Amongst the 344 selected donors, 15 (4.36%) had some type of adverse reaction associated with the procedure. We suggest that the selection criteria for plateletpheresis donors should be revised to deal with shortage of apheresis donors. The criteria regarding minimum pre-procedure platelet count (above1.5 lac/μl) and haemoglobin (above 12.5 g/dl) need to be lowered so as to suit the Indian scenario. The lower adverse reaction rates, 14/344 (4.06%) associated with this procedure encourages safety of donors and is important in recruitment of new donors.

  4. The frequency of anti-infliximab antibodies in patients with rheumatoid arthritis treated in routine care and the associations with adverse drug reactions and treatment failure

    DEFF Research Database (Denmark)

    Krintel, Sophine B; Grunert, Veit Peter; Hetland, Merete L

    2013-01-01

    To investigate the frequency of anti-infliximab antibodies in patients with RA and the associations with adverse drug reactions and treatment failure.......To investigate the frequency of anti-infliximab antibodies in patients with RA and the associations with adverse drug reactions and treatment failure....

  5. Adverse Events Associated with Flumazenil Treatment for the Management of Suspected Benzodiazepine Intoxication--A Systematic Review with Meta-Analyses of Randomised Trials

    DEFF Research Database (Denmark)

    Penninga, Elisabeth I; Graudal, Niels; Ladekarl, Morten Baekbo

    2016-01-01

    Flumazenil is used for the reversal of benzodiazepine overdose. Serious adverse events (SAEs) including seizures and cardiac arrhythmias have been reported in patients treated with flumazenil, and the clinical advantage of flumazenil treatment has been questioned. The objective was to assess...... with a total of 994 randomised (990 evaluable) patients were included. AEs were significantly more common in the flumazenil group (138/498) compared with the placebo group (47/492) (risk ratio: 2.85; 95% confidence interval: 2.11-3.84; p ... group compared with the placebo group (12/498 versus 2/492; risk ratio: 3.81; 95% CI: 1.28-11.39; p = 0.02). The most common AEs in the flumazenil group were agitation and gastrointestinal symptoms, whereas the most common SAEs were supraventricular arrhythmia and convulsions. No patients died during...

  6. Ginger for Prevention of Antituberculosis-induced Gastrointestinal Adverse Reactions Including Hepatotoxicity: A Randomized Pilot Clinical Trial.

    Science.gov (United States)

    Emrani, Zahra; Shojaei, Esphandiar; Khalili, Hossein

    2016-06-01

    In this study, the potential benefits of ginger in preventing antituberculosis drug-induced gastrointestinal adverse reactions including hepatotoxicity have been evaluated in patients with tuberculosis. Patients in the ginger and placebo groups (30 patients in each group) received either 500 mg ginger (Zintoma)(®) or placebo one-half hour before each daily dose of antituberculosis drugs for 4 weeks. Patients' gastrointestinal complaints (nausea, vomiting, dyspepsia, and abdominal pain) and antituberculosis drug-induced hepatotoxicity were recorded during the study period. In this cohort, nausea was the most common antituberculosis drug-induced gastrointestinal adverse reactions. Forty eight (80%) patients experienced nausea. Nausea was more common in the placebo than the ginger group [27 (90%) vs 21 (70%), respectively, p = 0.05]. During the study period, 16 (26.7%) patients experienced antituberculosis drug-induced hepatotoxicity. Patients in the ginger group experienced less, but not statistically significant, antituberculosis drug-induced hepatotoxicity than the placebo group (16.7% vs 36.7%, respectively, p = 0.07). In conclusion, ginger may be a potential option for prevention of antituberculosis drug-induced gastrointestinal adverse reactions including hepatotoxicity. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  7. Severe sleepiness and excess sleep duration induced by paroxetine treatment is a beneficial pharmacological effect, not an adverse reaction.

    Science.gov (United States)

    Murata, Yusuke; Kamishioiri, Yuko; Tanaka, Kenji; Sugimoto, Hiroko; Sakamoto, Shoko; Kobayashi, Daisuke; Mine, Kazunori

    2013-09-25

    Severe sleepiness and excess sleep duration, "Hypersomnia", induced by paroxetine treatment are generally considered adverse drug reactions, however, our experience indicates that patients with depressive disorder who experience "Hypersomnia" during paroxetine treatment have good clinical response. The aim of this study was to determine if "Hypersomnia" during paroxetine treatment is a beneficial pharmacological effect or an adverse drug reaction, and to investigate the impact of genetic polymorphisms on individual differences in the occurrence of "Hypersomnia" induced by paroxetine. A consecutive series of 46 Japanese patients with depressive disorder were treated with paroxetine. Patients who complained of great drowsiness or who slept for more than 12-h per day over seven days were identified as having experienced "Hypersomnia". For the clinical improvement rates and genotype distribution of the circadian locomotor output cycles kaput (CLOCK), serotonin transporter and cytochrome P450 2D6 (CYP2D6), the group that showed "Hypersomnia" induced by paroxetine treatment and the group that did not show "Hypersomnia" were compared statistically. Patients who experienced "Hypersomnia" (17.4%) showed a significantly higher response rate at two weeks than did patients who did not experience "Hypersomnia" (p=0.0127). No significant association between the occurrence of "Hypersomnia" and genetic polymorphisms was found. We cannot exclude the risk of false positive errors due to the relatively small sample sizes. "Hypersomnia" during paroxetine treatment for depression is a beneficial pharmacological effect, not an adverse drug reaction. © 2013 Elsevier B.V. All rights reserved.

  8. I'Adverse Drug Reactions in Children: TyPes, I ncidehbe,

    African Journals Online (AJOL)

    antigen-antibody reaction on the surface of mast cells . causes degranulation and release of pharmacologically ... Type IV (delayed, cell mediated) reactions: They are due to drug forming an antigenic conjugatewith .... organs and systems. A drug taken for a lung disease may affect the heart, and a drug taken to treat a cold.

  9. Adverse drug reactions to a cephalosporins in hospitalized patients with a history of penicillin allergy.

    Science.gov (United States)

    Fonacier, Luz; Hirschberg, Robert; Gerson, Steve

    2005-01-01

    Estimates on the cross-reactivity between cephalosporin and penicillin range from 1 to 16%. Patients with a history of penicillin allergy usually receive less optimal and more costly alternatives even if cephalosporins are a more viable alternative. One hundred eighty-six patients admitted to Winthrop University Hospital in a 7.5-month period, who reported penicillin allergy and received cephalosporin, were sent surveys. Eighty-three patients completed the survey and their charts were reviewed. Seven of 83 patients (8.4%) from a larger group of 186 penicillin-allergic patients developed a reaction to a cephalosporin. The exact 95% confidence interval is 3.5-16.6%. Six of seven (85.7%) penicillin-allergic patients who reacted to cephalosporin reported a definite history of an immediate reaction to penicillin, including hives. Only 1 of 62 (1.6%) patients who reported that their penicillin reaction was delayed, probable, or unknown had a cephalosporin reaction (p penicillin-allergic patients, who received a second-generation cephalosporin, had a reaction, whereas 5.5% (4 of 73 patients) of those patients given only a first-, third-, and fourth-generation cephalosporin reacted (p reaction, as compared with 3 of 68 (4.4%) patients who received a cephalosporin without the ring (p reactions had a rash, shortness of breath, difficulty swallowing, lightheadedness, and anaphylaxis. Patients who recall a definite history of an immediate type of penicillin allergy are more likely to develop a cephalosporin reaction compared with patients who reported a delayed, a probable, or an unknown penicillin reaction. Penicillin-allergic patients who receive second-generation cephalosporins, especially those with an amino benzyl side chain, are more likely to develop a reaction to cephalosporin. Although the incidence of reactions to cephalosporin in penicillin-allergic patients is low, those patients who reacted had more severe manifestations including anaphylaxis. Thus, continued

  10. A Review of Adverse Cutaneous Drug Reactions Resulting from the Use of Interferon and Ribavirin

    Directory of Open Access Journals (Sweden)

    Nisha Mistry

    2009-01-01

    Full Text Available Drug-induced cutaneous eruptions are named among the most common side effects of many medications. Thus, cutaneous drug eruptions are a common cause of morbidity and mortality, especially in hospital settings. The present article reviews different presentations of drug-induced cutaneous eruptions, with a focus on eruptions reported secondary to the use of interferon and ribavirin. Presentations include injection site reactions, psoriasis, eczematous drug reactions, alopecia, sarcoidosis, lupus, fixed drug eruptions, pigmentary changes and lichenoid eruptions. Also reviewed are findings regarding life-threatening systemic drug reactions.

  11. The importance of patch tests in the differential diagnosis of adverse drug reactions.

    Science.gov (United States)

    Travassos, Ana Rita; Pacheco, David; Antunes, Joana; Silva, Raquel; Almeida, Luís Soares; Filipe, Paulo

    2011-01-01

    Exudative erythema multiforme is an acute self-limited skin disease often associated with infections (usually viral), and also with systemic diseases and drugs. We report the case of a 39-year-old woman diagnosed with systemic lupus erythematosus, who presented at the emergency clinic with exudative erythema multiforme which started 10 days after taking amoxicillin and clavulanic acid for tonsillitis together (almost simultaneously) with the pneumococcal vaccine. Rowell's syndrome was also considered to be a possibility. Skin patch tests were carried with the standard battery of patches (GPEDC) and the active ingredients of the suspected drugs (Chemotechnique ®), with readings at D2 and D3. The tests were positive for amoxicillin 10% pet (++), ampicillin 10% pet (+ +) and penicillin G potassium 10% pet (+). We accepted the diagnosis of erythema multiforme due to amoxicillin, confirmed by patch testing.

  12. Patch testing and cross sensitivity study of adverse cutaneous drug reactions due to anticonvulsants: A preliminary report.

    Science.gov (United States)

    Shiny, T N; Mahajan, Vikram K; Mehta, Karaninder S; Chauhan, Pushpinder S; Rawat, Ritu; Sharma, Rajni

    2017-03-26

    To evaluate the utility of patch test and cross-sensitivity patterns in patients with adverse cutaneous drug reactions (ACDR) from common anticonvulsants. Twenty-four (M:F = 13:11) patients aged 18-75 years with ACDR from anticonvulsants were patch tested 3-27 mo after complete recovery using carbamazepine, phenytoin, phenobarbitone, lamotrigine, and sodium valproate in 10%, 20% and 30% conc. in pet. after informed consent. Positive reactions persisting on D3 and D4 were considered significant. Clinical patterns were exanthematous drug rash with or without systemic involvement (DRESS) in 18 (75%), Stevens-Johnsons syndrome/toxic epidermal necrolysis (SJS/TEN) overlap and TEN in 2 (8.3%) patients each, SJS and lichenoid drug eruption in 1 (4.2%) patient each, respectively. The implicated drugs were phenytoin in 14 (58.3%), carbamazepine in 9 (37.5%), phenobarbitone in 2 (8.3%), and lamotrigine in 1 (4.7%) patients, respectively. Twelve (50%) patients elicited positive reactions to implicated drugs; carbamazepine in 6 (50%), phenytoin alone in 4 (33.3%), phenobarbitone alone in 1 (8.3%), and both phenytoin and phenobarbitone in 1 (8.33%) patients, respectively. Cross-reactions occurred in 11 (92%) patients. Six patients with carbamazepine positive patch test reaction showed cross sensitivity with phenobarbitone, sodium valproate and/or lamotrigine. Three (75%) patients among positive phenytoin patch test reactions had cross reactions with phenobarbitone, lamotrigine, and/or valproate. Carbamazepine remains the commonest anticonvulsant causing ACDRs and cross-reactions with other anticonvulsants are possible. Drug patch testing appears useful in DRESS for drug imputability and cross-reactions established clinically.

  13. Adverse reactions following administration of contrast media for diagnostic imaging in anaesthetized dogs and cats: a retrospective study.

    Science.gov (United States)

    Scarabelli, Stefania; Cripps, Peter; Rioja, Eva; Alderson, Briony

    2016-09-01

    To evaluate incidences of adverse reaction after the administration of contrast media. Retrospective observational study. Animals included 356 dogs and 58 cats receiving non-ionic iodinated contrast agents, and 425 dogs and 49 cats receiving gadolinium-based contrast agents. Anaesthesia records of dogs and cats receiving intravenous (IV) gadobutrol for magnetic resonance imaging (MRI) or IV iohexol for computed tomography (CT) were reviewed. Changes in pulse rate, respiratory rate and mean arterial pressure at 5 minutes after administration of the contrast medium were evaluated. Changes of 10-20% were considered mild, those of >20% moderate, and reactions that required immediate treatment were considered severe. Associations of sex, age and weight with contrast reaction were investigated using logistic regression. Differences in the incidences of reactions to CT and MRI contrast media were examined with chi-squared tests. A p-value of  0.2). Of dogs receiving iohexol, 64 (18.0%) had mild, 65 (18.3%) had moderate and three (0.8%) had severe reactions. Of dogs receiving gadobutrol, 42 (9.9%) had mild, 87 (20.5%) had moderate and one (0.2%) had a severe reaction. When dogs receiving iohexol were compared with those receiving gadobutrol, the odds ratio of a moderate reaction was 2.0 (95% confidence interval 1.34-3.10; p = 0.001). These estimates did not change substantially after adjustment for age, weight and sex. Severe reactions to iohexol and gadobutrol are rare in dogs and cats; moderate reactions are more likely with iohexol than with gadobutrol. © 2015 Association of Veterinary Anaesthetists and the American College of Veterinary Anesthesia and Analgesia.

  14. Oral Adverse Reactions Caused by Over-the-Counter Oral Agents

    Directory of Open Access Journals (Sweden)

    Vanja Vucicevic Boras

    2015-01-01

    Full Text Available Over-the-counter products rarely cause unwanted reactions in the oral cavity. Oral reactions to these agents are not specific and might present with various clinical oral findings. Detailed medical history is a key to the proper diagnosis of these lesions and fortunately other diagnostic procedures are rarely needed. Lesions are usually managed with elimination of the offending agent and with topical steroids. In more severe cases systemic steroids should be applied.

  15. Adverse drug reactions associated with off-label use of ketorolac, with particular focus on elderly patients. An analysis of the Italian pharmacovigilance database and a population based study.

    Science.gov (United States)

    Viola, E; Trifirò, G; Ingrasciotta, Y; Sottosanti, L; Tari, M; Giorgianni, F; Moretti, U; Leone, R

    2016-12-01

    This study aims to evaluate the frequency of off-label use of ketorolac in Italy and the related suspected adverse drug reactions (ADRs) reported. All the suspected cases associated with ketorolac recorded in the Italian Pharmacovigilance database were retrieved. Case evaluations were carried out in order to identify the off-label use of ketorolac. Moreover, an analysis of the inappropriate use of ketorolac was conducted using the 'Arianna' database of Caserta local health unit. Up to December 2014, 822 reports of suspected ADRs related to ketorolac were retrieved in the database. The use of ketorolac was classified as off-label for 553 reports and on-label for 269. Among the off-label cases, 58.6% were serious compared to 39.0% of on-label cases. Gastrointestinal events were more frequently reported with off-label use. The analysis of Arianna database showed that 37,729 out of 61,910 patients, were treated off-label. The off-label use of ketorolac is widespread in Italy. This use increases the risk of serious ADR, especially in in case of prolonged duration of treatment and in elderly patients. The Italian Medicine Agency has decided to accurately monitor the appropriate use of the drug in Italy and, if necessary, take measures in order to minimize the risks.

  16. Atopic diseases: Risk factor in developing adverse reaction to intravenous N-Acetylcysteine

    Directory of Open Access Journals (Sweden)

    F Gheshlaghi

    2006-05-01