WorldWideScience

Sample records for adverse reaction reporting

  1. 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.

  2. Clinical survey on adverse reaction of contrast media, final report

    International Nuclear Information System (INIS)

    This report is a final analysis of adverse reactions to iodinated contrast media examined in 33,440 patients from 11 hospitals during the period from October 1983 through June 1986. Adverse reactions, such as nausea, exanthema and vomiting, to contrast media occurred in 2,523 patients (7.5 %), with the higher number occuring in patients aged 40 - 60, irrespective of sex. There were no significant alternations in vital signs. Patients positive for pretesting and having a history of allergy had higher incidences of adverse reactions (48 % and 52 %, respectively). A history of allergy is the most potential predictor for adverse reactions to contrast media. There was no definitive correlation between prior medication of contrast media and the occurrence of their adverse reactions. The relationship between the occurrence of adverse reactions and both kinds and dosage of contrast media was unknown. (Namekawa, K.)

  3. Consumer reporting of adverse drug reactions

    DEFF Research Database (Denmark)

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

    2009-01-01

    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...... reported fewer ADRs from the ATC group B (blood and blood-forming organs) [OR = 0.04; 95% CI 0.006, 0.32] and the ATC groups J (anti-infective for systemic use) [OR = 0.44; 95% CI 0.33, 0.58], L (antioneoplastic and immunomodulating agents) [OR = 0.19; 95% CI 0.12, 0.30] and V (various) [OR = 0.03; 95% CI...

  4. Adverse drug reactions to ibuprofen: a case report

    Directory of Open Access Journals (Sweden)

    Khobragade Yadneshwar

    2016-02-01

    Full Text Available Ibuprofen is a commonly used drug available by prescription and over the counter for treatment of fever, joint pain, headache, migraine, inflammatory states. It is available in combination with paracetamol and various other drugs. Side effects associated with aspirin and non-steroidal anti-inflammatory drugs (NSAIDs are rash, gastrointestinal ulcers, hepatic toxicity, Steven Johnson syndrome, respiratory skin rashes, acute exacerbation of asthma and anaphylaxis. We have reported here severe distress hypersensitive reaction with ibuprofen induced hypersensitivity syndrome. Within two hours of consumption of ibuprofen patient developed severe bronchospasm, throat and laryngeal oedema leading to respiratory distress. He was treated with salbutamol, hydrocortisone, deriphylline and supportive oxygen, but did not respond and went into coma. Unlike acetaminophen, ibuprofen does not have any antidote hence managing adverse drug reactions (ADR due to ibuprofen is big challenge. Therefore understanding pathophysiology of ADR to Ibuprofen is necessary to manage the patient. Literature in the field of allergic drug reaction shows that epinephrine, a physiological antagonist of histamine is the first drug of choice for the treatment of allergic or drug induced angioedema, laryngeal oedema and bronchospasm due to its direct action on target organs. Such reactions should therefore be managed by epinephrine without loss of time. ADR due to ibuprofen could be prevented by (a avoiding unnecessary intake of drug, (b educating patients / families and public about adverse drug reactions (c surveillance and monitoring of drug reactions (d record keeping (e drug audit and (f reporting of ADR to state/central pharmacovigilance agency. We do observe doctors having misconception about adrenaline, its actions, usage and side effects especially cardio-vascular, hence are reluctant to use. But in severe violent adverse drug reaction we have to use our wisdom and judgement

  5. Information about adverse drug reactions reported in children

    DEFF Research Database (Denmark)

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

    2010-01-01

    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......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...... 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...

  6. Knowledge, Attitude and Practice of Adverse Drug Reaction Reporting among Health Professionals in Southwest Ethiopia

    OpenAIRE

    Mulugeta Tarekegn Angamo; Nasir Tajure Wabe

    2012-01-01

    AIM: Adverse drug reaction is noxious and unwanted reaction to drugs at dose used in humans for diagnosis, treatment or prophylaxis. Adverse drug reaction monitoring is an area of drug information that has been given little attention yet. Spontaneous reporting is currently the major back bone for the detection of adverse drug reactions. The objective of this study was to assess the knowledge, attitude and practices of adverse drug reaction reporting among health professionals in selected heal...

  7. Suspected adverse reactions to veterinary drugs reported in South Africa (January 1998 - February 2001 : special report

    Directory of Open Access Journals (Sweden)

    R. Gehring

    2001-07-01

    Full Text Available The Veterinary Pharmacovigilance Centre received 59 reports of suspected adverse drug reactions during the period January 1998 - February 2001. The number of reports received increased after the establishment of a formal procedure for recording and responding to reports. The number of reports received per species was: dogs 19, cats 15, cattle 7, sheep/ goats 6, chickens 4, pigs 3, horses 2 and giraffe 1. Many different types of adverse reactions were reported, including lack of efficacy, hypersensitivity, inappropriate use of products by non-veterinarians, known adverse effects and adverse effects encountered with extra-label use of products.

  8. Perception of Nigerian medical students on adverse drug reaction reporting.

    Science.gov (United States)

    Abubakar, Abdullahi Rabiu; Chedi, Bashir A Z; Mohammed, Khalid Garba; Haque, Mainul

    2015-01-01

    Spontaneous reporting (SPR) and intensive monitoring are the conventional systems used for detecting, recording, and reporting adverse drug reactions (ADRs). Using spontaneous reporting a lot of successes has been made as existing ADRs were identified and new ones prevented through this methods. The aim of this appraisal was to evaluate the knowledge, attitude, and the practice of medical students with regards to ADRs reporting and to see if differences exist between the level of study and genders. The questionnaire was adopted, modified, and validated from previous studies. It comprised of 25 questions. It was administered year-IV and V medical students of Bayero University Kano, Nigeria. The data collected were coded and analyzed using the Statistical Package for the Social Sciences (SPSS) version 20, currently known as IBM SPSS Statistics. The response rate was 74%. Among the 108 participants, 80% got the definition of ADRs correct; 63% of them knew the precise functions of pharmacovigilance (PV). In addition, 82% strongly agreed that ADR reporting is health care workers responsibility; 82% also said PV should be taught in detail. Meanwhile, 99% have noticed patient experiencing ADRs; 67% said even mild ADRs should be reported. The outcome of this study showed good knowledge and attitude with respect to ADRs and PV among the medical students surveyed. Unfortunately, the practice of medical students was found to be unsatisfactory. There is a need to upgrade the students teaching the curriculum with respect to ADRs monitoring. PMID:26605155

  9. Perception of Nigerian medical students on adverse drug reaction reporting

    Directory of Open Access Journals (Sweden)

    Abdullahi Rabiu Abubakar

    2015-01-01

    Full Text Available Spontaneous reporting (SPR and intensive monitoring are the conventional systems used for detecting, recording, and reporting adverse drug reactions (ADRs. Using spontaneous reporting a lot of successes has been made as existing ADRs were identified and new ones prevented through this methods. The aim of this appraisal was to evaluate the knowledge, attitude, and the practice of medical students with regards to ADRs reporting and to see if differences exist between the level of study and genders. The questionnaire was adopted, modified, and validated from previous studies. It comprised of 25 questions. It was administered year-IV and V medical students of Bayero University Kano, Nigeria. The data collected were coded and analyzed using the Statistical Package for the Social Sciences (SPSS version 20, currently known as IBM SPSS Statistics. The response rate was 74%. Among the 108 participants, 80% got the definition of ADRs correct; 63% of them knew the precise functions of pharmacovigilance (PV. In addition, 82% strongly agreed that ADR reporting is health care workers responsibility; 82% also said PV should be taught in detail. Meanwhile, 99% have noticed patient experiencing ADRs; 67% said even mild ADRs should be reported. The outcome of this study showed good knowledge and attitude with respect to ADRs and PV among the medical students surveyed. Unfortunately, the practice of medical students was found to be unsatisfactory. There is a need to upgrade the students teaching the curriculum with respect to ADRs monitoring.

  10. Adverse drug reaction reports of patients and healthcare professionals-differences in reported information

    NARCIS (Netherlands)

    Rolfes, Leàn; van Hunsel, Florence; Wilkes, Sarah; Grootheest, Kees van; Puijenbroek, Eugène van

    2015-01-01

    PURPOSE: This study aims to explore the differences in reported information between adverse drug reaction (ADR) reports of patient and healthcare professionals (HCPs), and, in addition, to explore possible correlation between the reported elements of information. METHODS: This retrospective study co

  11. Quality check of spontaneous adverse drug reaction reporting forms of different countries.

    Science.gov (United States)

    Bandekar, M S; Anwikar, S R; Kshirsagar, N A

    2010-11-01

    Adverse drug reactions (ADRs) are considered as one of the leading causes of death among hospitalized patients. Thus reporting of adverse drug reactions become an important phenomenon. Spontaneous adverse drug reaction reporting form is an essential component and a major tool of the pharmacovigilance system of any country. This form is a tool to collect information of ADRs which helps in establishing the causal relationship between the suspected drug and the reaction. As different countries have different forms, our aim was to study, analyze the suspected adverse drug reaction reporting form of different countries, and assess if these forms can capture all the data regarding the adverse drug reaction. For this analysis we identified 18 points which are essential to make a good adverse drug reaction report, enabling proper causality assessment of adverse reaction to generate a safety signal. Adverse drug reaction reporting forms of 10 different countries were collected from the internet and compared for 18 points like patient information, information about dechallenge-rechallenge, adequacy of space and columns to capture necessary information required for its causality assessment, etc. Of the ADR forms that we analyzed, Malaysia was the highest scorer with 16 out of 18 points. This study reveals that there is a need to harmonize the ADR reporting forms of all the countries because there is a lot of discrepancy in data captured by the existing ADR reporting forms as the design of these forms is different for different countries. These incomplete data obtained result in inappropriate causality assessment. PMID:20845409

  12. 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. PMID:27510377

  13. Adverse Reaction to Nicotine Gum in Malay Female Smoker: A Case Report

    Science.gov (United States)

    Noorzurani, Md Haris Robson; Bond, Alyson; Wolff, Kim

    2008-01-01

    Nicotine replacement therapies (NRT) are prescribed in smoking cessation programmes to help smokers stop smoking. The ideal dosage of NRT should control cravings and withdrawal symptoms but avoid adverse reactions. This report describes a case of adverse reaction to nicotine gum in a female Malay smoker. Assays taken 2 h after the gum, showed that…

  14. Adverse reactions to radiopharmaceuticals

    International Nuclear Information System (INIS)

    Full text. An adverse reaction can occur following administration of a radio pharmaceutical, but fortunately reactions are uncommon. They are usually mild and do not require intensive treatment. This is probably related to the fact that only small chemical quantities of material are administered to patients and that only one or a small number of doses are administered. Since symptoms are unrelated to any known pharmacology of the agents, they can be described as Type B reactions according to the classification of Rawlings and Thompson. Types of reaction that occur and possible mechanisms will be described. The reactions most commonly observed are skin rashes and vasomotor symptoms. It is important that, as far as possible, a cause - effect relationship can be established between the administration of the radio pharmaceutical and the symptoms caused. Some classification schemes therefore exclude vasomotor reactions such as hypotension and slow pulse, since such events can arise in a variety of clinical situations unrelated to radio pharmaceutical administration. It is important for nuclear medicine departments to be aware of the nature of reactions such that they can be recognized and appropriate re-assurance and/or prompt treatment can be given to their patients. Radio pharmaceuticals most frequently mentioned in reporting schemes are di phosphonates used for bone imaging. This probably reflect the fact that these agents are the most frequently used in current practice rather than that they cause more reactions. Problems in establishing the overall frequency of adverse reactions to radio pharmaceuticals include the fact that events may not be recognized if they occur after the patient has left the Nuclear Medicine Department and that reactions are never reported. Two recent studies have attempted to obtain more definitive information by performing prospective studies in a large number of departments. A study in the USA found that there was a rate of 2.3 events per

  15. Limitations and obstacles of the spontaneous adverse drugs reactions reporting: Two "challenging" case reports

    Directory of Open Access Journals (Sweden)

    Caterina Palleria

    2013-01-01

    Full Text Available Introduction: Nowadays, based on several epidemiological data, iatrogenic disease is an emerging public health problem, especially in industrialized countries. Adverse drugs reactions (ADRs are extremely common and, therefore, clinically, socially, and economically worthy of attention. Spontaneous reporting system for suspected ADRs represents the cornerstone of the pharmacovigilance, because it allows rapid detection of potential alarm signals related to drugs use. However, spontaneous reporting system shows several limitations, which are mainly related to under-reporting. In this paper, we describe two particular case reports, which emphasize some reasons of under-reporting and other common criticisms of spontaneous reporting systems. Materials and Methods: We performed a computer-aided search of Medline, PubMed, Embase, Cochrane library databases, national and international databases of suspected ADRs reports in order to identify previous published case reports and spontaneous reports about the ADRs reviewed in this paper, and to examine the role of suspected drugs in the pathogenesis of the described adverse reactions. Results: First, we reported a case of tizanidine-induced hemorrhagic cystitis. In the second case report, we presented an episode of asthma exacerbation after taking bimatoprost. Through the review of these two cases, we highlighted some common criticisms of spontaneous reporting systems: under-reporting and false causality attribution. Discussion and Conclusion: Healthcare workers sometimes do not report ADRs because it is challenging to establish with certainty the causal relationship between drug and adverse reaction; however, according to a key principle of pharmacovigilance, it is always better to report even a suspicion to generate an alarm in the interest of protecting public health.

  16. Self-reported adverse reactions among patients initiating antiretroviral therapy in Brazil

    Directory of Open Access Journals (Sweden)

    Cristiane A. Menezes de Pádua

    2007-02-01

    Full Text Available A cross-sectional analysis was carried out to describe adverse reactions to antiretroviral therapy (ART reported by HIV-infected patients initiating treatment at two public health AIDS referral centers in Belo Horizonte, Brazil, 2001-2003 and to verify their association with selected variables. Adverse reactions were obtained through interview at the first follow-up visit (first month after the antiretroviral prescription. Socio-demographic and behavioral variables related to ART were obtained from baseline and follow-up interviews and clinical variables from medical charts. Patients with four or more reactions were compared to those with less than four. Odds ratio with 95% confidence interval were estimated using logistic regression model for both univariate and multivariate analyses. At least one adverse reaction was reported by 92.2% of the participants while 56.2% reported four or more different reactions. Antiretroviral regimens including indinavir/ritonavir, irregular use of antiretrovirals and switch in regimens were independently associated with four or more adverse reactions (OR=7.92, 5.73 and 2.03, respectively. The initial period of ARV treatment is crucial and patients´ perception of adverse reactions should be carefully taken into account. Strategies for monitoring and management of adverse reactions including the choice of regimens and the prevention of irregular ART should be developed in AIDS/HIV referral centers in Brazil to promote better adherence to antiretroviral therapy.

  17. Low quality of reporting adverse drug reactions in paediatric randomised controlled trials

    NARCIS (Netherlands)

    de Vries, Tjalling W; van Roon, Eric N

    2010-01-01

    OBJECTIVE: Randomised controlled trials (RCT) offer an opportunity to learn about frequency and character of adverse drug reactions. To improve the quality of reporting adverse effects, the Consort group published recommendations. The authors studied the application of these recommendations in RCTs

  18. Self-reported adverse reactions among patients initiating antiretroviral therapy in Brazil

    OpenAIRE

    Cristiane A. Menezes de Pádua; Cibele C. César; Palmira F. Bonolo; Francisco A. Acurcio; Mark Drew C. Guimarães

    2007-01-01

    A cross-sectional analysis was carried out to describe adverse reactions to antiretroviral therapy (ART) reported by HIV-infected patients initiating treatment at two public health AIDS referral centers in Belo Horizonte, Brazil, 2001-2003 and to verify their association with selected variables. Adverse reactions were obtained through interview at the first follow-up visit (first month) after the antiretroviral prescription. Socio-demographic and behavioral variables related to ART were obtai...

  19. Knowledge, Attitude and Practice of Adverse Drug Reaction Reporting among Health Professionals in Southwest Ethiopia

    Directory of Open Access Journals (Sweden)

    Mulugeta Tarekegn Angamo

    2012-08-01

    Full Text Available AIM: Adverse drug reaction is noxious and unwanted reaction to drugs at dose used in humans for diagnosis, treatment or prophylaxis. Adverse drug reaction monitoring is an area of drug information that has been given little attention yet. Spontaneous reporting is currently the major back bone for the detection of adverse drug reactions. The objective of this study was to assess the knowledge, attitude and practices of adverse drug reaction reporting among health professionals in selected health facilities in southwest Ethiopia. METHOD: A cross-sectional study design was used among health professionals in selected health facilities in January 2010. Prescribers other than physicians, junior pharmacy technicians and also health assistants were excluded. Data was collected using self administered questionnaires from volunteered physicians (Medical interns and above, nurses (Diploma and above and Pharmacy professionals (Diploma and above and analyzed using SPSS version 16.0. RESULTS: A total of 82 health professionals were participated in the study. From those 82 participants, only 19 (23.17% and 21 (25.61% knew the existence of national reporting system and a yellow card of adverse drug reaction reporting form. Thirteen (15.85% participants encountered adverse drug reaction in the past 12 months in their clinical activities, but none of them reported to responsible body. Even though the participants’ knowledge and practice were inadequate, most of the respondents 47 (57.31% agreed that adverse drug reaction reporting is part of duty of them and important to the public in general and to the patient in particular. CONCLUSION: There was no documentation and reporting of adverse drug reaction, which might partly be explained by lack of knowledge and misconceptions about spontaneous reporting. Our study strongly suggests that there is a great need to create awareness and to promote the reporting of adverse drug reaction amongst health professionals

  20. 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...

  1. Adverse drug reactions to ibuprofen: a case report

    OpenAIRE

    Khobragade Yadneshwar; Khobragade Sujata

    2016-01-01

    Ibuprofen is a commonly used drug available by prescription and over the counter for treatment of fever, joint pain, headache, migraine, inflammatory states. It is available in combination with paracetamol and various other drugs. Side effects associated with aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) are rash, gastrointestinal ulcers, hepatic toxicity, Steven Johnson syndrome, respiratory skin rashes, acute exacerbation of asthma and anaphylaxis. We have reported here sever...

  2. Adverse reactions to cosmetics

    OpenAIRE

    Dogra A; Minocha Y; Kaur S

    2003-01-01

    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 ...

  3. Adverse Drug Reaction Reports of Patients and Healthcare Professionals : How Different Are They?

    NARCIS (Netherlands)

    Rolfes, Leàn; van Hunsel, Florence; van Puijenbroek, Eugène; van Grootheest, Adrianus

    2013-01-01

    Background: Changes in the European pharmacovigilance legislation make it possible for patients of all European member states to report concerns regarding drugs directly to the national reporting centre for adverse drug reactions (ADRs). Despite a number of studies that have been conducted on patien

  4. 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...

  5. Development Tool for Self-Reporting of Adverse Drug Reactions of Statin

    OpenAIRE

    Hadeer Akram AbdulRazzaq; Noorizan Abd Aziz; Syed Azhar Syed Sulaiman; Yahaya Hassan; Omar Ismail

    2011-01-01

    Introduction: Statins cause adverse drug reactions (ADRs) in patients on chronic use of medications. No specific tool available for patients to report these ADRs. Most of previous studies based on the doctors’ reports.Aim: development specific tool for reporting of satins-ADRs for cardiac outpatients, and to determine the incidences and correlations among these ADRs. Method: the questionnaire based on the commonly reported ADRs of statins, researchers' agreements and the consistent understan...

  6. Overview of suspected adverse reactions to veterinary medicinal products reported in South Africa (March 2004 - February 2006 : report

    Directory of Open Access Journals (Sweden)

    V. Naidoo

    2006-06-01

    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 2004 to February 2006 is presented. A total of 21 reports was received in the 2-year period, continuing the decline in the number of reports to a lower figure than in any previous year. This is surprising considering the legal obligation of the veterinary professionals to report all adverse drug reactions. Once again the majority of reports involved suspected adverse reactions that occurred in dogs and cats. Most of the products implicated were stock remedies. Veterinarians predominantly administered these products.

  7. 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

  8. Adverse reactions to cosmetics

    Directory of Open Access Journals (Sweden)

    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.

  9. Spontaneous Reporting of Adverse Drug Reactions through Electronic Submission from Regional Society Healthcare Professionals in Korea

    OpenAIRE

    Lee, Jae-Hyun; Park, Kyung Hee; Moon, Hyun Joo; Lee, Yong Won; Park, Jung-Won; Hong, Chein-Soo

    2012-01-01

    Purpose Pharmacovigilance Research Network built a spontaneous reporting system and collected adverse drug reactions (ADRs) by electronic submission (e-sub) in Korea. We analyzed ADRs spontaneously reported through e-sub from regional health professionals. Materials and Methods Nine hundred and thirty three ADR cases were collected and analyzed from January to December in 2008. "A matter" was defined as one symptom matched to one culprit drug included in an ADR case. We collected and analyzed...

  10. Preventable and potentially preventable serious adverse reactions induced by oral protein kinase inhibitors through a database of adverse drug reaction reports.

    Science.gov (United States)

    Egron, Adeline; Olivier-Abbal, Pascale; Gouraud, Aurore; Babai, Samy; Combret, Sandrine; Montastruc, Jean-Louis; Bondon-Guitton, Emmanuelle

    2015-06-01

    Antineoplastic drugs are one of the pharmacological classes more frequently involved in occurrence of "serious" adverse drug reactions. However, few epidemiological data are available regarding the preventability of adverse drug reactions with ambulatory cancer chemotherapy. We assessed the rate and characteristics of "preventable" or "potentially preventable" "serious" adverse drug reactions induced by oral protein kinase inhibitors (PKIs). We performed a retrospective study with all "serious" adverse drug reactions (ADRs) recorded from 1 January 2008 to 31 December 2009 in the French Pharmacovigilance Database with the eight oral protein kinase inhibitors marketed in France: sorafenib, imatinib, erlotinib, sunitinib, dasatinib, lapatinib, nilotinib and everolimus (Afinitor®) using the French adverse drug reactions preventability scale. This study was carried out on 265 spontaneous notifications. Most of adverse drug reactions were "unpreventable" (63.8 %). Around one third were "unevaluable" due to notifications poorly documented (medical history, dosage, use of drugs as first or second intention, concomitant drugs). One (0.4 %) adverse drug reaction was "preventable" with dasatinib (subdural hematoma) and three (1.1 %) were "potentially preventable" (hepatic adverse drug reactions): two with imatinib and one with sorafenib. For these four cases, we identified some characteristics: incorrect dosages, drug interactions and off-label uses. An appropriate prescription could avoid the occurrence of 1.5 % "serious" adverse drug reactions with oral PKIs. This rate is low and further studies are needed to compare our results by using other preventability instruments and to improve the French ADRs Preventability Scale. PMID:25056801

  11. 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

  12. Adverse reaction after hyaluronan injection for minimally invasive papilla volume augmentation. A report on two cases

    DEFF Research Database (Denmark)

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

    2016-01-01

    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...... directly above the mucogingival junction, (ii) injection into the attached gingiva/mucosa below the missing papilla, and (iii) injection 2-3 mm apically to the papilla tip. The whole-injection session was repeated once after approximately 4 weeks. RESULTS: Both patients presented with swelling and extreme...

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

    Directory of Open Access Journals (Sweden)

    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.

  14. 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

  15. The 34th report on survey of the adverse reaction to radiopharmaceuticals. The 37th survey in 2011

    International Nuclear Information System (INIS)

    This survey was performed in order to investigate the incidence of adverse reactions to radiopharmaceuticals in FY2011 in Japan. It was based on responses to questionnaires sent to nuclear medicine institutions. The reply was obtained from 999 institutions among 1,253 to which the questionnaire had been sent. Fourteen cases of adverse reactions were reported. A total of 1,068,833 radiopharmaceutical administrations was reported. The incidence of adverse reactions per 100,000 cases was 1.3. One case of defect products was reported, and the incidence of defect products per 100,000 cases was 0.1. (author)

  16. The 35th report on survey of the adverse reaction to radiopharmaceuticals. The 38th survey in 2012

    International Nuclear Information System (INIS)

    This survey was performed in order to investigate the incidence of adverse reactions to radiopharmaceuticals in FY2012 in Japan. It was based on responses to questionnaires sent to nuclear medicine institutions. The reply was obtained from 977 institutions among 1,251 to which the questionnaire had been sent. Eleven cases of adverse reactions were reported. A total of 1,060,526 radiopharmaceutical administrations was reported. The incidence of adverse reactions per 100,000 cases was 1.0. One case of defect products was reported, and the incidence of defect products per 100,000 cases was 0.1. (author)

  17. Musculoskeletal adverse drug reactions: a review of literature and data from ADR spontaneous reporting databases.

    Science.gov (United States)

    Conforti, Anita; Chiamulera, Christian; Moretti, Ugo; Colcera, Sonia; Fumagalli, Guido; Leone, Roberto

    2007-01-01

    The musculoskeletal system can be a target organ for adverse drug reactions (ADRs). Drug-induced muscle, bone or connective tissue injuries may be due to, i), primary direct drug action, or, ii), undirected consequence of generalized drug-induced disease. Musculoskeletal ADRs may be only temporarily disabling, such as muscle cramps, as well as in other cases may be serious and life-threatening, such as rhabdomyolysis. In the last few years there has been an increasing awareness of musculoskeletal ADRs. Some recent drug safety issues dealt with serious or uncommon musculoskeletal reactions like rhabdomyolysis associated to statins and tendon rupture associated to fluoroquinolones. In this review, we firstly selected those drug classes having a significantly high percentage of musculoskeletal disorder reports in the WHO adverse drug reaction database, maintained by the Uppsala Monitoring Centre. Secondly, the different musculoskeletal ADRs were closely analyzed through the data obtained from an Italian interregional ADRs spontaneous reporting database. The findings on drugs associated to different musculoskeletal disorders, have been integrated with a review of the epidemiological data available in the literature. For the most involved drugs (HMG-CoA reductase inhibitors, fluoroquinolones, corticosteroids, bisphosphonates, retinoids) the underlying musculoskeletal ADR mechanisms were also reviewed and discussed. PMID:18690950

  18. Safety of Cartrophen Vet in the dog: review of adverse reaction reports in the UK.

    Science.gov (United States)

    Hannon, R L; Smith, J G; Cullis-Hill, D; Ghosh, P; Cawdery, M J Hope

    2003-05-01

    Suspected adverse reactions (SARs) reported for Cartrophen Vet (100 mg sodium pentosan polysulphate/ml) to the Veterinary Medicines Directorate in the UK for the period January 1991 to October 1999 were reviewed. Of the 161 reports, 28 were probably product related, 54 were possibly product related, 71 were unlikely to be related and eight were unclassified. An estimated real incidence of adverse reactions probably and possibly associated with Cartrophen Vet of 0.074 per cent on an individual dose basis was calculated (assuming only 10 per cent were documented due to underreporting). Sixty-two SARs (38.5 per cent) documented emesis, 22 (35.5 per cent) of which were product related (onset five to 15 minutes after administration). Sixty-eight SARs (42.2 per cent) documented general changes to demeanour, 10 (14.7 per cent) were product related (lethargy and/or mild depression and/or mild inappetence lasting up to two days after administration). Six SARs were considered likely to be associated with concurrently administered carprofen. Cartrophen Vet had a low incidence of side effects that were mild and transitory. PMID:12779171

  19. 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

  20. 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.

  1. 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.

  2. Awareness and attitudes of healthcare professionals in Wuhan, China to the reporting of adverse drug reactions

    Institute of Scientific and Technical Information of China (English)

    李青; 张素敏; 陈华庭; 方世平; 于星; 刘东; 施侣元; 曾繁典

    2004-01-01

    Background A voluntary procedure for reporting adverse drug reactions (ADRs) was formally put in place in 1989. However, only a small proportion of ADR reports are actually forwarded to the national monitoring center. To identify the reasons for underreporting, the authors investigated the awareness and attitudes of healthcare professionals (doctors, nurses, and administrators) toward the ADR system in China. In addition, the authors sought to formulate approaches to improve the current ADR reporting system.Methods Structured interviews were carried out in 16 hospitals selected from 27 municipal hospitals in Wuhan, Hubei Province, China. A questionnaire survey of a stratified random sample of approximately 15% of healthcare professionals in each selected hospital was conducted during February to March 2003.Results The response rate of this survey was 85%. One thousand six hundred and fifty-three questionnaires were used in the final analysis. Only 2.7% of the healthcare professionals had a correct understanding to the definition of ADR. Eighty-nine point two percent of the healthcare professionals had encountered ADRs. Ninety-four percent of them were aware of the need to report these to the ADR monitoring center. However, only 28.5% of doctors, 22.8% of nurses, and 29.7% of administrators actually submitted a report. For the most part, they reported ADRs to the hospital pharmacy (66.0%), to other departments in the hospital (72.5%), and to the pharmaceutical industry (23.0%), rather than to the national monitoring center (2.9%) or regional monitoring center (9.5%). Severe or rare ADRs and ADRs to new products were generally perceived to be significant enough to report. Sixty-two point one percent of the healthcare professionals had encountered ADRs, yet not reported them to anybody. The major reasons for not reporting included no knowledge of the reporting procedure (71.4%), unavailability of the reporting center mailing address (67.9%), unavailability of the ADR

  3. 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.

  4. [Adverse reaction of pseudoephedrine].

    Science.gov (United States)

    López Lois, G; Gómez Carrasco, J A; García de Frías, E

    2005-04-01

    We present a case of a 7 years old girl who developed an episode of myoclonic movements and tremors after being medicated with a not well quantified amount of a pseudoephedrine/antihistamine combination. We want to highlight the potential toxicity of pseudoephedrine, usually administered as part of cold-syrup preparations which are used for symptomatic treatment of upper respiratory tract cough and congestion associated with the common cold and allergic rhinitis. Although these products are generally considered to be safe either by physicians and parents, we can't underestimate the potential adverse events and toxic effects that can occur when administering these medications. PMID:15826569

  5. 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. PMID:26935093

  6. 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.

  7. 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

  8. 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

  9. Adverse Drug Reaction Reporting Pattern in Turkey: Analysis of the National Database in the Context of the First Pharmacovigilance Legislation

    OpenAIRE

    Ozcan, Gulnihal; Aykac, Emel; KASAP, Yelda; Nemutlu, Nergiz T.; Sen, Ebru; Aydinkarahaliloglu, N. Demet

    2016-01-01

    Introduction In Turkey, pharmacovigilance began in 1985. A fully structured adverse drug reaction (ADR)-reporting system was established with the publication of the first pharmacovigilance regulation in 2005. Subsequent regulation published in 2014 brought further improvements to the system. Objective In this study, we aimed to analyse the ADR-reporting pattern in the context of the first pharmacovigilance legislation in Turkey. Methods We analysed ADR reports submitted to the Turkish Pharmac...

  10. Refill adherence and self-reported adverse drug reactions and sub-therapeutic effects : a population-based study

    OpenAIRE

    Hedna, Khedidja; Hägg, Staffan; Andersson Sundell, Karolina; Petzold, Max; Hakkarainen, Katja M

    2013-01-01

    PURPOSE: To assess refill adherence to dispensed oral long-term medications among the adult population and to investigate whether the percentages of self-reported adverse drug reactions (ADRs) and sub-therapeutic effects (STEs) differed for medications with adequate refill adherence, oversupply, and undersupply. METHOD: Survey responses on self-reported ADRs and STEs were linked to the Swedish Prescribed Drug Register in a cross-sectional population-based study. Refill adherence to antihypert...

  11. Life threatening biphasic adverse reactions to desmopressin: case report and review of the literature.

    Science.gov (United States)

    Wang, Lijun; Chen, Ruijun; Tian, Fang; Wang, Wei; Wang, Li; Yu, Baojun; Huang, Xianwen; Zhang, Yuehui; Su, Shengyuan; Ma, Guangnian; Wang, Kaichen

    2016-08-01

    Treatment with desmopressin diacetate arginine vasopressin (DDAVP) and its withdrawal are associated with side effects. We present a rare case of severe biphasic adverse reactions induced by DDAVP and its withdrawal in a 63-year-old female patient. A lump in the left axillary region was biopsied, and she received DDAVP after surgery. The following day, she lost consciousness, with foaming at the mouth and seizures. Hypotonic encephalopathy was considered. DDAVP was ceased, and she received electrolytes. On day 1, she displayed low blood pressure and increased urine output. She received DDAVP and dopamine as well as electrolytes. The patient was ambulatory on day 7 and was discharged without brain abnormalities on MRI. In conclusion, severe hyponatremia induced by DDAVP and massive polyuria and hypovolemic shock induced by DDAVP withdrawal are life-threatening conditions. This case underlines the need to be vigilant when administering DDAVP and to monitor for any side effects. PMID:27142268

  12. [Research on early warning signals of adverse drug reactions to parenterally administered xiyanping based on spontaneous reporting system (SRS) data].

    Science.gov (United States)

    Wang, Zhi-Fei; Xiang, Yong-Yang; Xie, Yan-Ming

    2013-09-01

    This article focused on early warning signals regarding the safety of parenterally administered Xiyanping. The study data was obtained from reports made between 2005-2012 from the national spontaneous reporting system (SRS). Proportion reporting ratio (PRR) and Bayesian confidence propagation neural network (BCPNN) algorithms were used to analyse: erythra, pruritus, anaphylactoid reactions and shiver with cold, these 4 adverse drug reactions had a total count of more than 500 events. The article found that Xiyanping's incidence rate of erythra was higher than for background-drugs in every year and in every season. Pruritus was an early warning signal in the second season of 2009, and anaphylactoid reaction was an early warning signal in the fourth season of 2011 and in the second season of 2012. There was however no early warning signal indicated by shiver with cold. This data indicates that erythra maybe an adverse drug reactions to parenterally administered Xiyanping, and if the incidence rate of pruritus and anaphylactoid reaction rises attention should be paid to its safety. PMID:24471321

  13. Report of thirty one admissions due to adverse drug reactions inBo-Ali Sina hospital, Sari, Iran

    Directory of Open Access Journals (Sweden)

    Mohammad Reza Rafati

    2009-01-01

    Full Text Available , (Received 16 May, 2009 ; Accepted 8 July, 2009AbstractBackground and purpose: Adverse drug reactions (ADRs are one of the leading causes of morbidity and mortality, worldwide. Mortality rate due to ADRs are ahead of pulmonary disease, AIDS, pneumonia and automobile accidents. This study evaluated the admission rates in a University teaching hospital related to ADRs.Materials and methods: During this retrospective study between 2001 and 2007, all patients admitted due to adverse drug reaction in Sari Bo-Ali Sina Hospital were evaluated.Results: In these years, 31 patients out of 71,680 were admitted, due to ADRs. Most common ADRs were skin reaction (74% and fever (22%. Phenobarbital and penicillin were the most common drugs causing ADRs.Conclusion: Only 0.04% of hospital admissions were drug related, while reported admission due to ADRs in other countries were 2.4 to 6.2%. It appears that less drug-depended hospital admissions in Iran rational drug administration, but are due to lack of enough detection, records and reporting procedures.J Mazand Univ Med Sci 2009; 19(71: 67-70 (Persian.

  14. Patients views and experiences in online reporting adverse drug reactions: findings of a national pilot study in Japan

    Directory of Open Access Journals (Sweden)

    Yamamoto M

    2015-01-01

    Full Text Available Michiko Yamamoto,1 Kiyoshi Kubota,2 Mitsuhiro Okazaki,3 Akira Dobashi,3 Masayuki Hashiguchi,4 Hirohisa Doi,1 Machi Suka,5 Mayumi Mochizuki4 1Education Center for Clinical Pharmacy Practice, Showa Pharmaceutical University, Tokyo, Japan; 2Department of Pharmacoepidemiology, Graduate School of Medicine, University of Tokyo, Japan; 3Education and Research Institute of Information Science, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan; 4Division for Evaluation and Analysis of Drug Information, Faculty of Pharmacy, Keio University, Tokyo, Japan; 5Department of Public Health and Environmental Medicine, The Jikei University School of Medicine, Tokyo, Japan Background: Patients have been allowed to report adverse drug reactions (ADRs directly to the government in some countries, which would contribute to pharmacovigilance.Objective: We started a pilot study to determine whether web-based patient ADR reporting would work in Japan. This article aims to describe the characteristics of the patient reporters, and to clarify patient views and experiences of reporting.Methods: Patients who submitted online ADR reports were contacted to respond to an ADR reporting questionnaire; only consenting reporters were included. Subjects with multiple responses were excluded from analysis. The questionnaire consisted of both closed and open questions. Questionnaire responses were examined using Pearson’s chi-squared test.Results: A total of 220 web-based ADR reports were collected from January to December 2011; questionnaires were sent to 190 reporters, excluding those who gave multiple reports and those that refused to be contacted. Responses were obtained from 94 individuals (effective response rate: 49.5%. The median respondent age was 46.0 years. Sixty-three respondents found out about this pilot study on the Internet (67.0%. The numbers of respondents claiming that they had difficulty recalling the time/date of ADR occurrence were 16 patient

  15. Revisiting cutaneous adverse reactions to pemetrexed

    OpenAIRE

    Piérard-Franchimont, Claudine; Quatresooz, Pascale; Reginster, Marie‑Annick; Piérard, Gérald E.

    2011-01-01

    Pemetrexed (Alimta®) is a multitargeted antifolate drug approved as a single agent or in combination with cisplatin for the treatment of a small number of malignancies including advanced and metastatic non-squamous non-small cell lung cancer (NSCLC), and malignant pleural mesothelioma. This review reports the recent peer-reviewed publications and original findings regarding cutaneous adverse reactions (CARs) to pemetrexed. Pemetrexed-related CARs are frequently reported under the unspecific t...

  16. 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 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Adverse reaction file. (a) Records shall be maintained of any reports of complaints of adverse...

  17. Adverse reactions of Methylphenidate in children with attention deficit-hyperactivity disorder: Report from a referral center

    OpenAIRE

    Khajehpiri, Zahra; Mahmoudi-Gharaei, Javad; Faghihi, Toktam; Karimzadeh, Iman; Khalili, Hossein; Mohammadi, Mostafa

    2014-01-01

    Objective: The aim of the current study was to determine various aspects of methylphenidate adverse reactions in children with attention deficit-hyperactivity disorder (ADHD) in Iran. Methods: During the 6 months period, all children under methylphenidate treatment alone or along with other agents attending a university-affiliated psychology clinic were screened regarding all subjective and objective adverse drug reactions (ADRs) of methylphenidate. Causality and seriousness of detected ADRs ...

  18. An evaluation of knowledge, attitude, and practice of adverse drug reaction reporting among prescribers at a tertiary care hospital

    Directory of Open Access Journals (Sweden)

    Chetna K Desai

    2011-01-01

    Full Text Available Objectives: Spontaneous reporting is an important tool in pharmacovigilance. However, its success depends on cooperative and motivated prescribers. Under-reporting of adverse drug reactions (ADRs by prescribers is a common problem. The present study was undertaken to evaluate the knowledge, attitude, and practices (KAP regarding ADR reporting among prescribers at the Civil Hospital, Ahmedabad, to get an insight into the causes of under-reporting of ADRs. Materials and Methods: A pretested KAP questionnaire comprising of 15 questions (knowledge 6, attitude 5, and practice 4 was administered to 436 prescribers. The questionnaires were assessed for their completeness (maximum score 20 and the type of responses regarding ADR reporting. Microsoft Excel worksheet (Microsoft Office 2007 and Chi-Square test were used for statistical analysis. Results: A total of 260 (61% prescribers completed the questionnaire (mean score of completion 18.04. The response rate of resident doctors (70.7% was better than consultants (34.5% (P < 0.001. ADR reporting was considered important by 97.3% of the respondents; primarily for improving patient safety (28.8% and identifying new ADRs (24.6%. A majority of the respondents opined that they would like to report serious ADRs (56%. However, only 15% of the prescribers had reported ADRs previously. The reasons cited for this were lack of information on where (70% and how (68% to report and the lack of access to reporting forms (49.2%. Preferred methods for reporting were e-mail (56% and personal communication (42%. Conclusion: The prescribers are aware of the ADRs and the importance of their reporting. However, under reporting and lack of knowledge about the reporting system are clearly evident. Creating awareness about ADR reporting and devising means to make it easy and convenient may aid in improving spontaneous reporting.

  19. Cross-sectional study exploring barriers to adverse drug reactions reporting in community pharmacy settings in Dhaka, Bangladesh

    Science.gov (United States)

    Amin, Mohammad Nurul; Khan, Tahir Mehmood; Dewan, Syed Masudur Rahman; Islam, Mohammad Safiqul; Moghal, Mizanur Rahman

    2016-01-01

    Objectives To assess community pharmacists'/pharmacy technicians' knowledge and perceptions about adverse drug reactions (ADRs) and barriers towards the reporting of such reactions in Dhaka, Bangladesh. Method A cross-sectional study was planned to approach potential respondents for the study. A self-administered questionnaire was delivered to community pharmacists/pharmacy technicians (N=292) practising in Dhaka, Bangladesh. Results The overall response to the survey was 69.5% (n=203). The majority of the sample was comprised of pharmacy technicians (152, 74.9%) who possessed a diploma in pharmacy, followed by pharmacists (37, 18.2%) and others (12, 5.9%). Overall, 72 (35.5%) of the respondents disclosed that they had experienced an ADR at their pharmacy, yet more than half (105, 51.7%) were not familiar with the existence of an ADR reporting body in Bangladesh. Exploring the barriers to the reporting of ADRs, it was revealed that the top four barriers to ADR reporting were ‘I do not know how to report (Relative Importance Index (RII)=0.998)’, ‘reporting forms are not available (0.996)’, ‘I am not motivated to report (0.997)’ and ‘Unavailability of professional environment to discuss about ADR (RII=0.939)’. In addition to these, a majority (141, 69.46%) were not confident about the classification of ADRs (RII=0.889) and were afraid of legal liabilities associated with reporting ADRs (RII=0.806). Moreover, a lack of knowledge about pharmacotherapy and the detection of ADRs was another major factor hindering their reporting (RII=0.731). Conclusions The Directorate of Drug Administration in Bangladesh needs to consider the results of this study to help it improve and simplify ADR reporting in Bangladeshi community pharmacy settings. PMID:27489151

  20. Attitude of nurses and pharmacists on adverse drug reactions reporting in selected hospitals in Sokoto, Northwest Nigeria

    Science.gov (United States)

    Umar, Muhammad Tukur; Bello, Shaibu Oricha; Chika, Aminu; Oche, Oche Mansur

    2016-01-01

    Objective: Objective of this study was to assess the attitude of nurses and pharmacists towards adverse drug reactions (ADRs) reporting. Methods: The questionnaire was designed based on extended “Inman seven deadly sins.” Two hundred and seventy-two respondents were selected by stratified sampling technique. The questionnaires were delivered to the respondents at their places of practice. The data generated were analyzed by Sigma XL Software Inc. Findings: There was no statistically significant relationship between demographic profiles and reporting attitude except for qualification. On extended “Inman seven deadly sins” awareness of reporting protocol and nearby center for ADRs reporting were low 27.3 and 7.5%, respectively. However, respondents’ score on components of attitude of ADRs reporting is generally encouraging. On comparative basis, no statistical significance exists between pharmacists and nurses. Conclusion: The study showed that attitude of respondents towards ADRs reporting is good. However, there is a need for targeted health education intervention among these cadres of health-care professionals, especially on aspects of awareness of reporting protocol and reporting center.

  1. Adverse reactions to injectable aesthetic microimplants.

    Science.gov (United States)

    Requena, C; Izquierdo, M J; Navarro, M; Martínez, A; Vilata, J J; Botella, R; Amorrortu, J; Sabater, V; Aliaga, A; Requena, L

    2001-06-01

    New inert materials such as polymerized silicones, Bioplastique, Artecoll, and Dermalive are now being used as injectable aesthetic microimplants. These substances are better than the old ones because they tend not to migrate and do not usually produce much of a host immune response. Adverse reactions after injection of these materials are rare, although there are a few reported cases as a result of bad technique or anomalous granulomatous reactions. We report on four patients with unsightly results after cosmetic microimplants, including one of Artecoll, one of Dermalive (to the best of our knowledge, the latter is the first such case reported), and two of silicone. This report describes the histopathologic features of cutaneous reactions to these injectable aesthetic materials. PMID:11391099

  2. Monitoring Adverse Drug Reactions: A Preliminary Study

    OpenAIRE

    Reynolds, J. L.

    1981-01-01

    The feasibility of family physicians functioning as monitors of adverse drug reactions (ADR) was examined over one month in ten practices. This was done as a preliminary trial, before attempting to use the 200 family physicians of the National Reporting System of the College of Family Physicians of Canada to monitor ADRs on a national basis. Both of these trials were designed to examine the feasibility of family physicians acting as prospective monitors of ADRs in newly marketed drugs and to ...

  3. Adverse Reactions of Ferric Carboxymaltose

    OpenAIRE

    Thanusubramanian, Harish; Patil, Navin; Shenoy, Smita; Bairy, K. L.; Sarma, Yashdeep

    2014-01-01

    The author reports a 55-year-old female diagnosed of chronic kidney disease grade-5 with associated co-morbidities like type 2 diabetes mellitus, diabetic retinopathy and hypothyroidism was admitted for arteriovenous fistula construction. She was started on ferric carboxymaltose for the treatment of anaemia. She was given a test dose before administering the drug intravenously and she did not develop any reaction. The drug ferric carboxymaltose was then administered over a period of one hour....

  4. Abuse liability of flupirtine revisited: implications of spontaneous reports of adverse drug reactions.

    Science.gov (United States)

    Gahr, Maximilian; Freudenmann, Roland W; Connemann, Bernhard J; Hiemke, Christoph; Schönfeldt-Lecuona, Carlos

    2013-12-01

    Early studies suggested that the centrally acting non-opioid and non-steroidal analgesic flupirtine (FLP) has no potential for abuse. However, FLP's agonistic effects at the GABAA receptor might prime addictive behaviors, and literature provides some anecdotal reports on FLP abuse/dependence. To shed more light on this topic we acquired and evaluated data obtained from a national German pharmacovigilance database. We analyzed all reports of FLP abuse/dependence that were recorded in the database of the German Federal Institute for Drugs and Medical Devices (BfArM). A total of n = 48 reports of FLP abuse/dependence could be identified (mean age 45 years, 62.5% female). First reports were submitted to BfArM in 1991 with increasing numbers of annual reports from the year 2006 on. Mean daily FLP dosage was 805 mg (range 200-3,000 mg). Current or previous substance abuse/dependence was reported in 21% and 17%, respectively. Mean duration of FLP abuse/dependence until report to BfArM was 23 months (range 1-84 months). Withdrawal syndromes after discontinuation of FLP were reported in n = 9 (19%). Our findings strengthen the hypothesis that FLP features a potential to cause addictive behaviors. Female sex, age >40 years, and long-term FLP-treatment may be possible risk factors for the development of FLP abuse/dependence. PMID:24037995

  5. An evaluation of knowledge, attitude and practice of Indian pharmacists towards adverse drug reaction reporting: A pilot study

    Directory of Open Access Journals (Sweden)

    Akram Ahmad

    2013-01-01

    Full Text Available Background: Pharmacovigilance is a useful to assure the safety of medicines and protect consumers from their harmful effects. Healthcare professionals should consider Adverse Drug Reaction (ADR reporting as part of their professional obligation and participate in the existent pharmacovigilance programs in their countries. In India, the National PV Program was re-launched in July 2010. Objectives: This survey was conducted in order to assess the knowledge, attitude and practice of Indian pharmacists with the aim of exploring the pharmacists′ participation in ADR reporting system, identifying the reasons of under reporting and determining the steps that could be adopted to increase reporting rates. Materials and Methods: A cross-sectional survey was carried out among the pharmacists in India using a pretested questionnaire with 33 questions (10 questions on knowledge, 6 on attitude, 7 on practice, 7 on future of ADR reporting in India and 3 on benefits of reporting ADRs.. The study was conducted, over a period of 3 months from May 2012 to July 2012. Results: Out of the 600 participants to whom the survey was administered, a total of 400 were filled. The response rate of the survey was 67%. 95% responders were knowledgeable about ADRs. 90% participants had a positive attitude towards making ADRs reporting mandatory for practicing pharmacists. 87.5% participants were interested in participating in the National Pharmacovigilance program, in India. 47.5% respondents had observed ADRs in their practice, and 37% had reported it to the national pharmacovigilance center. 92% pharmacists believed reporting ADRs immensely helped in providing quality care to patients. Conclusion : The Indian pharmacists have poor knowledge, attitude, and practice (KAP towards ADR reporting and pharmacovigilance. Pharmacists with higher qualifications such as the pharmacists with a PharmD have better KAP. With additional training on Pharmacovigilance, the Indian Pharmacists

  6. An evaluation of knowledge, attitude, and practice of adverse drug reaction reporting in a tertiary care teaching hospital of Sikkim

    Directory of Open Access Journals (Sweden)

    Supratim Datta

    2015-01-01

    Full Text Available Aim: Spontaneous voluntary adverse drug reaction (ADR reporting is paramount to the success of the Pharmacovigilance Programme of India. There has however been minimal and sporadic voluntary reporting of ADR's at the ADR Monitoring Centre (AMC Gangtok, Sikkim. Knowledge, perception, attitude, and awareness of health professionals are determinants of reporting practices. This questionnaire study aims at evaluating these indicators in the teaching hospital attached to the Medical Institute and find out methods to improve existing reporting practices. Materials and Methods: This is a cross-sectional questionnaire-based observational study carried out in the Medical, Surgical and Pathology Departments of the Teaching Hospital, Gangtok, Sikkim over a period of 2 months. The questionnaires were filled by the respondents and returned back to us within the next 24 h. Data obtained from filled questionnaires were thereby analyzed. Results: The overall correct response rate to the knowledge-based questions was 56.3%. While 97% of respondents were of the view that ADR reporting was necessary, 35% of the respondents felt that the difficulty in deciding the causality of an ADR discouraged them from reporting. 79% of the respondents were not aware of the presence of an AMC affiliated to the hospital, and 87% of the respondents admitted that they were not sending filled ADR forms to the AMC. Conclusions: The study indicates that the respondents have an average knowledge and positive attitude toward ADR reporting and pharmacovigilance. There is however a lack of awareness and poor ADR reporting practices. Efforts are required to enhance awareness and attitude toward pharmacovigilance and ADR reporting.

  7. Adverse reactions of ferric carboxymaltose.

    Science.gov (United States)

    Thanusubramanian, Harish; Patil, Navin; Shenoy, Smita; Bairy, K L; Sarma, Yashdeep

    2014-10-01

    The author reports a 55-year-old female diagnosed of chronic kidney disease grade-5 with associated co-morbidities like type 2 diabetes mellitus, diabetic retinopathy and hypothyroidism was admitted for arteriovenous fistula construction. She was started on ferric carboxymaltose for the treatment of anaemia. She was given a test dose before administering the drug intravenously and she did not develop any reaction. The drug ferric carboxymaltose was then administered over a period of one hour. About half an hour after drug administration, the patient developed breathlessness and myalgia. After half hour of the above episode of breathlessness and myalgia she also developed vomiting (one episode). Patient was managed with oxygen therapy, IV fluids and other drugs like corticosteroids, phenaramine maleate and nalbuphine which controlled the above symptoms. PMID:25478369

  8. Adverse reaction to metal bearing leading to femoral stem fractures: a literature review and report of two cases

    Science.gov (United States)

    Al-Azzani, Waheeb A.K.; Iqbal, Hafiz J.; John, Alun

    2016-01-01

    Metal-on-metal (MoM) bearing in total hip replacement (THR) has a high failure rate due to adverse reaction to metal debris (ARMD). There is a spectrum of soft tissue and bony changes in ARMD including muscle necrosis and osteolysis. In our institution, more than 1500 MoM THRs were implanted since 2003. Recently, we have revised significant numbers of these. We report our experience and management of a mode of failure of MoM THR that has been infrequently reported—the distal femoral stem fracture. We report on two patients who presented with worsening pain attributable to fracture of the femoral stem. Severe femoral osteolysis led to loss of proximal stem support and eventual fatigue fracture of the component. Both patients were revised employing a posterior approach. Bone trephine was used to extract a well-fixed distal stem fragment without any windows. Both patients had successful outcome after revision with excellent pain relief and no complications. PMID:26846269

  9. Adverse Reactions to Radiographic Contrast Material

    OpenAIRE

    Bush, William H.; Mullarkey, Michael F.; Webb, D. Robert

    1980-01-01

    Major adverse reactions to radiographic contrast media will occur more often as contrast material is now also administered during computerized tomographic (CT) scanning. Differentiation of the two major contrast reactions, the vagus reaction and the anaphylactoid reaction, is essential. Bradycardia is the key finding for identifying the vagus reaction. The vagus reaction involving hypotension and bradycardia requires treatment with large doses of atropine given intravenously. The immediate ge...

  10. Analysis of 251 cases of adverse drug reactions in our hospital report%我院251例药品不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    唐锦辉

    2013-01-01

      purpose: to understand adverse drug reactions in our hospital (Adverse Drug Reaction) the incidence and relevant factors, provide reference for rational drug use, avoid the occurrence of adverse drug reactions. Methods: 251 cases on our 2011 colection statistics, analysis of ADR reports. Results 251 cases ADR report total involved 16 class drugs, vein drops note is caused ADR of main to drug way (201 cases); antibiotics occurred rate Supreme (142 cases), second is proprietary Chinese medicines (28 cases), and antipyretic analgesia drug (20 cases), and anti-tumor drug (16 cases), and effect blood and hematopoietic system of drug (12 cases); clinical performance main for skin and damage (99 cases), accounted for 39.44%, digestive system of of damage (75 cases) accounted for 29.88%. Conclusion: ADR is related to many factors relevant to clinical ADR monitoring work should be strengthened to reduce or avoid the occurrence of ADR.

  11. Seriousness, preventability, and burden impact of reported adverse drug reactions in Lombardy emergency departments: a retrospective 2-year characterization

    Directory of Open Access Journals (Sweden)

    Perrone V

    2014-12-01

    Full Text Available Valentina Perrone,1,* Valentino Conti,2,* Mauro Venegoni,2 Stefania Scotto,2 Luca Degli Esposti,3 Diego Sangiorgi,3 Lucia Prestini,4 Sonia Radice,1 Emilio Clementi,5,6 Giuseppe Vighi,2,4 1Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, University Hospital Luigi Sacco, Università di Milano, Milan, Italy; 2Regional Centre for Pharmacovigilance, Lombardy, Milan, Italy; 3CliCon Srl, Health, Economics and Outcomes Research, Ravenna, Italy; 4Unit of Clinical Pharmacology and Pharmacovigilance, Niguarda Ca’Granda Hospital, Milan, Italy; 5Unit of Clinical Pharmacology, CNR Institute of Neuroscience, Department of Biomedical and Clinical Sciences, University Hospital Luigi Sacco, Università di Milano, Milan, Italy; 6Scientific Institute, IRCCS Eugenio Medea, Lecco, Italy *These authors contributed equally to the work Objective: The purpose of this study was to determine the prevalence of adverse drug reactions (ADRs reported in emergency departments (EDs and carry out a thorough characterization of these to assess preventability, seriousness that required hospitalization, subsequent 30-day mortality, and economic burden. Methods: This was a retrospective cohort study of data from an active pharmacovigilance project at 32 EDs in the Lombardy region collected between January 1, 2010 and December 31, 2011. Demographic, clinical, and pharmacological data on patients admitted to EDs were collected by trained and qualified monitors, and deterministic record linkage was performed to estimate hospitalizations. Pharmacoeconomic analyses were based on Diagnosis-Related Group reimbursement. Results: 8,862 ADRs collected with an overall prevalence rate of 3.5 per 1,000 visits. Of all ADRs, 42% were probably/definitely preventable and 46.4% were serious, 15% required hospitalization, and 1.5% resulted in death. The System Organ Classes most frequently associated with ADRs were: skin and subcutaneous tissue, gastrointestinal

  12. Pharmacogenomics and adverse drug reactions in children

    OpenAIRE

    Rieder, Michael J; Carleton, Bruce

    2014-01-01

    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...

  13. Snake antivenoms: adverse reactions and production technology

    OpenAIRE

    VM Morais; H Massaldi

    2009-01-01

    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 ...

  14. Seriousness, preventability, and burden impact of reported adverse drug reactions in Lombardy emergency departments: a retrospective 2-year characterization

    Science.gov (United States)

    Perrone, Valentina; Conti, Valentino; Venegoni, Mauro; Scotto, Stefania; Degli Esposti, Luca; Sangiorgi, Diego; Prestini, Lucia; Radice, Sonia; Clementi, Emilio; Vighi, Giuseppe

    2014-01-01

    Objective The purpose of this study was to determine the prevalence of adverse drug reactions (ADRs) reported in emergency departments (EDs) and carry out a thorough characterization of these to assess preventability, seriousness that required hospitalization, subsequent 30-day mortality, and economic burden. Methods This was a retrospective cohort study of data from an active pharmacovigilance project at 32 EDs in the Lombardy region collected between January 1, 2010 and December 31, 2011. Demographic, clinical, and pharmacological data on patients admitted to EDs were collected by trained and qualified monitors, and deterministic record linkage was performed to estimate hospitalizations. Pharmacoeconomic analyses were based on Diagnosis-Related Group reimbursement. Results 8,862 ADRs collected with an overall prevalence rate of 3.5 per 1,000 visits. Of all ADRs, 42% were probably/definitely preventable and 46.4% were serious, 15% required hospitalization, and 1.5% resulted in death. The System Organ Classes most frequently associated with ADRs were: skin and subcutaneous tissue, gastrointestinal, respiratory thoracic and mediastinal, and nervous system disorders. The most common Anatomical Therapeutic Chemical classes involved in admissions were J (anti-infectives and immunomodulating agents), B (blood and blood-forming organs), and N (nervous system). Older age, yellow and red triage, higher number of concomitantly taken drugs, and previous attendance in ED for the same ADR were significantly associated with an increased risk of hospitalization. The total cost associated with ADR management was €5,184,270, with a mean cost per patient of €585. Fifty-eight percent of the economic burden was defined as probably/definitely preventable. Conclusion ADRs are a serious health/economic issue in EDs. This assessment provides a thorough estimation of their seriousness, preventability, and burden impact in a large population from a representative European region. PMID

  15. 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...

  16. Analysis of adverse reaction reports of penicillin drugs%青霉素类药物不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    张兵; 冯变玲; 赵晓红; 吉天天

    2013-01-01

    目的比较注射与口服青霉素类药物不良反应的差别。方法采用回顾性分析方法对2007~2012年江苏省不良反应中心收集到的青霉素类药品的不良反应报告进行分析。结果江苏省注射用青霉素的不良反应数为6082例,占92.98%;口服青霉素的不良反应数为454例,占6.94%。注射用青霉素有新的严重的不良反应2例。注射用青霉素不良反应病例经治疗后有9例死亡病例,3例病人留下后遗症;口服青霉素的不良反应经治疗后均痊愈或好转。结论口服青霉素类药物不良反应数量少,且严重程度低,经治疗后无死亡或留下后遗症的病例。%Objective Compare with injection penicillin drugs and oral penicillin drugs for ADR .Method The adverse reaction re-ports of penicillin drugs collected by Jiangsu adverse reaction center from 2007 to 2012 were analyzed retrospectively .Result The case number of adverse reactions of injection penicillin was 6 082 ,accounting for 92 .98% ;Oral penicillin adverse reactions num-ber was 454 cases ,accounting for 6 .94% ;The injection penicillin drugs had new serious adverse reactions in 2 cases ;After the treatment of injection penicillin adverse reaction ,9 cases were die and 3 cases left sequela ;On the other hand ,the cases of oral penicillin adverse reactions were recoveried or better after treatment .Conclusion For the adverse drug reactions of oral penicillin , the quantity was less and the serious degree was low and no death or sequela was reported after treatment .

  17. Evaluation of patient reporting of adverse drug reactions to the UK ‘Yellow Card Scheme’: literature review, descriptive and qualitative analyses, and questionnaire surveys

    OpenAIRE

    Avery, A J; Anderson, Claire; Bond, C M; Fortnum, H.; Gifford, A.; Hannaford, P. C.; Hazell, L; Krska, J; Lee, A. J.; McLernon, D. J.; Murphy, Elizabeth; Shakir, S; Watson, M. C.

    2011-01-01

    Background: The monitoring of adverse drug reactions (ADRs) through pharmacovigilance is vital to patient safety. Spontaneous reporting of ADRs is one method of pharmacovigilance, and in the UK this is undertaken through the Yellow Card Scheme (YCS). Yellow Card reports are submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) by post, telephone or via the internet. The MHRA electronically records and reviews information submitted so that important safety ...

  18. Adverse reactions to new anticonvulsant drugs.

    Science.gov (United States)

    Wong, I C; Lhatoo, S D

    2000-07-01

    A lack of systematic pharmacoepidemiological studies investigating adverse drug reactions (ADRs) to anticonvulsants makes it difficult to assess accurately the incidence of anticonvulsant-related ADRs. Most of the available information in this regard stems from clinical trial experience, case reports and postmarketing surveillance, sources that are not, by any means, structured to provide precise data on adverse event epidemiology. For various ethical, statistical and logistical reasons, the organisation of structured clinical trials that are likely to provide substantial data on ADRs is extremely difficult. This review concentrates on current literature concerning serious and life-threatening ADRs. As with the older anticonvulsants, the majority of ADRs to newer anticonvulsants are CNS-related, although there are several that are apparently unique to some of these new drugs. Gabapentin has been reported to cause aggravation of seizures, movement disorders and psychiatric disturbances. Felbamate should only be prescribed under close medical supervision because of aplastic anaemia and hepatotoxicity. Lamotrigine causes hypersensitivity reactions that range from simple morbilliform rashes to multi-organ failure. Psychiatric ADRs and deterioration of seizure control have also been reported with lamotrigine treatment. Oxcarbazepine has a safety profile similar to that of carbamazepine. Hyponatraemia associated with oxcarbazepine is also a problem; however, it is less likely to cause rash than carbamazepine. Nonconvulsive status epilepticus has been reported frequently with tiagabine, although there are insufficient data at present to identify risk factors for this ADR. Topiramate frequently causes cognitive ADRs and, in addition, also appears to cause word-finding difficulties, renal calculi and bodyweight loss. Vigabatrin has been reported to cause seizure aggravation, especially in myoclonic seizures. There have been rare reports of other neurological ADRs to

  19. Management of acute adverse reactions to contrast media

    Energy Technology Data Exchange (ETDEWEB)

    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, S5 7AU, Sheffield (United Kingdom)

    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. (orig.)

  20. 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. PMID:14740165

  1. 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.

  2. Study and evaluation of the various cutaneous adverse drug reactions in Kasturba hospital, Manipal

    Directory of Open Access Journals (Sweden)

    Ghosh S

    2006-01-01

    Full Text Available The present study emphasizes on implementation of the adverse drug reaction reporting and monitoring system, in the Dermatology department of Kasturba Hospital, Manipal, by a clinical pharmacist, using different promotional activities. Documented adverse drug reactions were assessed and analyzed for incidence, purpose of visit, types, drug classes, individual drug causing adverse drug reactions, type of cutaneous reaction, and various predisposing factors. Management and outcome of the adverse drug reactions were also studied. Adverse drug reactions were also assessed for causality, using Naranjo′s scale, severity, and preventability, using Hartwig et al. scale. Adverse drug reaction attributes to 77% of the hospital visit. Incidence of reported cutaneous adverse drug reactions, were 2.85%. Majority of the adverse drug reactions (96% were of type B. Antibiotics (30%, were the common class of drugs, causing a cutaneous adverse drug reactions. Maximum number of adverse drug reactions were due to Acetaminophen, Amoxicillin, antitubercular drugs, and Phenytoin. Most of the adverse drug reactions were managed by withdrawal of drug (81%, and 58% patients were recovered from the reaction. Naranjos scale classifies, 29 as probable, 21 as possible, and 3 as definite adverse drug reactions. Most of the adverse drug reactions were of moderate severity, however 13 adverse drug reactions were severe. All the adverse drug reactions were probably preventable on extreme caution.

  3. Prospective study of adverse reaction to intravenous administered contrast media

    International Nuclear Information System (INIS)

    This is a prospective study of the incidence of adverse reaction in those patients who accepted the intravenous urography (IVU) and enhanced computerized tomography (CT) at our hospital from September 1986 to January 1988. Of 7107 patients examined, complete records are available for 6917 (male 3760, female 3157). A record form of adverse reactions was constructed based on the symptoms reported by Ansell. Since some adverse reactions may occur with their own specific mechanism, they are sub-divided into four groups (physic, chemical toxic. Allergic and those that may involve multiple mechanisms are grouped as ''others'') according to the Felder's classification presented in the discussion. There was no record of the reactions belonging to the chemical toxic mechanism. The total incidence of the other groups are 82.4 % for physic, 4.8 % for allergic, 5.8 % for ''others'' and without any case of death. Two low-osmolality contrast media (LOCM) have significant lower incidence of adverse reaction than three high-osmolality contrast media (HOCM). Between two LOCM. Omnipaque is significant lower than Iopamiron in the incidence of either groups of mechanism (p < 0.01). Each LOCM and HOCM gives the same age distribution spectra of the incidence as reported, but the former have significant lower incidence of the adverse reaction than the latter. These results suggest that the LOCM may have a specific characteristics of the chemical property to induce the adverse reactions. (author)

  4. 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...

  5. Pharmacogenetics of idiosyncratic adverse drug reactions.

    Science.gov (United States)

    Pirmohamed, Munir

    2010-01-01

    Idiosyncratic adverse drug reactions are unpredictable and thought to have an underlying genetic etiology. With the completion of the human genome and HapMap projects, together with the rapid advances in genotyping technologies, we have unprecedented capabilities in identifying genetic predisposing factors for these relatively rare, but serious, reactions. The main roadblock to this is the lack of sufficient numbers of well-characterized samples from patients with such reactions. This is now beginning to be solved through the formation of international consortia, including developing novel ways of identifying and recruiting patients affected by these reactions, both prospectively and retrospectively. This has been led by the research on abacavir hypersensitivity - its association with HLA-B*5701 forms the gold standard of how we need to identify associations and implement them in clinical practice. Strong genetic predisposing factors have also been identified for hypersensitivity reactions such as are associated with carbamazepine, allopurinol, flucloxacillin, and statin-induced myopathy. However, for most other idiosyncratic adverse drug reactions, the genetic effect sizes have been low to moderate, although this may partly be due to the fact that only small numbers have been investigated and limited genotyping strategies have been utilized. It may also indicate that genetic predisposition will be dependent on multiple genes, with complex interactions with environmental factors. Irrespective of the strength of the genetic associations identified with individual idiosyncratic adverse drug reactions, it is important to undertake functional investigations to provide insights into the mechanism(s) of how the drug interacts with the gene variant to lead to a phenotype, which can take a multitude of clinical forms with variable severity. Such investigations will be essential in preventing the burden caused by idiosyncratic reactions, both in healthcare and in industry

  6. Adverse Event Reporting System (AERS)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all...

  7. A Survey of Adverse Drug Reactions in Family Practice

    OpenAIRE

    Reynolds, J. L.

    1984-01-01

    In this study, 232 Canadian family physicians recorded suspected adverse drug reactions (SADRs) in their practices for five months. Patients' age and sex, the drug(s) implicated, type of reaction and any disability were recorded on a card and sent to a central coordinating office each week. The number of SADRs in clinical practice seems to be small. An estimated 300,000 patients were involved in the study, and a total of 314 suspected adverse drug reactions in 314 patients were reported. A pr...

  8. Children and ADRs (Adverse Drug Reactions

    Directory of Open Access Journals (Sweden)

    Napoleone Ettore

    2010-01-01

    Full Text Available Abstract Many medicines are prescribed to the paediatric population on an unlicensed or 'off-label' basis because they have not been adequately tested and/or formulated and authorized for use in appropriate paediatric age groups. Regulatory authorities also need to remind health professionals about the importance of their contribution towards the process of paediatric pharmacovigilance thanks to their reporting of adverse drug reactions. The lack of reliable data in the paediatric population is associated with specific problems including: limited availability of safety data due to the lack of clinical trials in the paediatric population; under- or over-dosing in some age groups due to the lack of pharmacokinetics data or dose-finding studies; maturation, growth and development of the paediatric population susceptible to drug-induced growth and development disorders as well as to delayed ADRs not findable in adults. Pre-marketing trials are able to provide information about the benefits of drugs but do not manage to establish a safety profile. Spontaneous reporting of suspected ADRs become an important means to promote reasonable warning signs. Therefore some ADRs may be known in their qualitative aspect and quantitative aspect only after successful marketing and use in the population during a "normal" use. When the drug is used in clinical practice in large unselected populations, epidemiological post-marketing studies are useful as they find their major confirmation in recalling all the events that occur during monitoring, with estimates of incidence of ADRs that can not be obtained by spontaneous reports. In these studies a significant role can be played by the Family Pediatricians with the participation to active pharmacovigilance projects.

  9. Adverse drug reactions associated with asthma medications in children

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2014-01-01

    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...

  10. Adverse Drug Reactions Reported With Cholinesterase Inhibitors : An Analysis of 16 Years of Individual Case Safety Reports From VigiBase

    NARCIS (Netherlands)

    Kroeger, Edeltraut; Mouls, Marie; Wilchesky, Machelle; Berkers, Mieke; Carmichael, Pierre-Hugues; van Marum, Rob; Souverein, Patrick; Egberts, Toine; Laroche, Marie-Laure

    2015-01-01

    Background: No worldwide pharmacovigilance study evaluating the spectrum of adverse drug reactions (ADRs) induced by cholinesterase inhibitors (ChEI) in Alzheimer's disease has been conducted since their emergence on the market. Objective: To describe ChEI related ADRs in Alzheimer's disease (donepe

  11. Adverse reactions to milk in infants

    OpenAIRE

    Kvenshagen, Bente; Halvorsen, Ragnhild; Jacobsen, Morten

    2008-01-01

    Aim To study the age when symptoms of adverse reactions to milk occur, in premature and term children, the debut of various symptoms, immunoglobulin E (IgE)- and non-IgE-mediated reactions and the frequency of tolerance at 1 year. Methods Six hundred and eight children, 193 premature and 416 term infants, were followed. Symptomatic children were invited to a clinical examination. The criteria for the diagnosis were: histories of suspected cow's milk allergy (CMA) and proven IgE-mediated react...

  12. The Analysis of 358 Adverse Drug Reaction Reports in Children%358例儿童药品不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    陆晓彤; 刘海涛; 张健; 张春

    2011-01-01

    Objective: To summarize the results of adverse drug reaction supervision in our hospital from January in 2007 to June in 2010 in order to improve rational and safe clinical drug treatment for children. Methods: Methods of descriptive study, statistics and analysis were used to estimate some characteristics of medicine usage. This included patients' basic conditions, route of administtration, ding combination and clinic manifestations. Results: Alnong 358 reports about adverse dlug reactions, there were 169 cases aged between 0 and 3 years, which accounted for 47.2%. There were 327 cases relating to the use of antibiotics, taking up 91.34% , in which there were 296 cases relating to β-lactaln antibiotics. The lnost usual adverse ding reaction caused by β-lactaln antibiotics were skin rashes, urticaria and anaphylactoid reactions. Alnong those 358 cases, adverse drug reaction occurred more easily when administrated via intravenous dropping method, which accounted for 83.24% (298 cases). Conclusions: There are more adverse drug reactions taking place in neonates and children when antibiotics are administrated by intravenous dropping method. This method of treatment needs to be further studied.%目的:总结我院2007年~2010年6月药品不良反应监测情况,促进临床安全、合理用药.方法:采用描述性研究的方法,对我院上报的药品不良反应分别从患者的基本情况、给药途径、联合用药、临床表现等方面进行统计、分析与评价.结果:358例不良反应监测报告中,患儿年龄0~3岁169例,占47.20%;与抗菌药物有关的327例,占91.34%,其中β内酰胺类296例,β内酰胺类引起的ADR多为皮疹、荨麻疹、过敏样反应;以静脉滴注途径给药的发生频率最高,共298例占83.24%.结论:我院婴幼儿抗菌药物静脉注射时发生的不良反应较多,应予以重点关注.

  13. 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.)

  14. Late adverse reactions to intravascular iodinated contrast media

    International Nuclear Information System (INIS)

    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.)

  15. 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...

  16. Adverse blood transfusion reactions at tertiary care hospital

    OpenAIRE

    Surekha K. Chavan; Gorakhnath Patil; Pallavi Rajopadhye

    2016-01-01

    Background: The goal of hemovigilance is to increase the safety and quality of blood transfusion. It is necessary to recognize and prompt response to adverse transfusion reactions, which will help in taking appropriate steps to reduce their incidence and make blood transfusion process as safe as possible. The aim of the study was to determine the frequency and type of transfusion reactions (TRs) occurring in patients, reported to the blood bank at our institute. Methods: A retrospective r...

  17. Adverse reactions to acetylcysteine and effects of overdose.

    OpenAIRE

    Mant, T. G.; Tempowski, J H; Volans, G N; Talbot, J. C.

    1984-01-01

    Since the introduction in 1979 of intravenous acetylcysteine (Parvolex) as an antidote for overdosage of paracetamol the National Poisons Information Service and the manufacturer have been notified of 38 adverse reactions that were anaphylactoid in nature and 19 accidental overdoses. The most common feature of the anaphylactoid reaction to normal dosage was rash; other features reported included angioedema, hypotension, and bronchospasm; all the patients recovered. The features associated wit...

  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. PMID:8814889

  19. Self-Reported Prevalence of Symptomatic Adverse Reactions to Gluten and Adherence to Gluten-Free Diet in an Adult Mexican Population

    OpenAIRE

    Noe Ontiveros; López-Gallardo, Jesús A.; Vergara-Jiménez, Marcela J.; Francisco Cabrera-Chávez

    2015-01-01

    The prevalence of symptomatic adverse reactions to gluten and adherence to gluten-free diet in Latin American countries is unknown. These measurements are strongly linked to gluten-related disorders. This work aimed to estimate the prevalence of adverse reactions to oral gluten and the adherence to gluten-free diet in the adult Mexican population. To reach this aim, a self-administered questionnaire was designed and tested for clarity/comprehension and reproducibility. Then, a self-administer...

  20. Analysis of suspected adverse reactions following immunization against pandemic influenza

    Directory of Open Access Journals (Sweden)

    Petrović Vladimir

    2011-01-01

    Full Text Available Introduction. The surveillance on adverse reaction following immunization was aimed at recording all adverse events possibly related with vaccines. During the implementation of immunization strategy against pandemic influenza A(H1N1 in 2009, the post-marketing comprehensive surveillance was suggested to be conducted due to limited clinical experience in applying this particular vaccine and because of the fact that some vaccines had been licensed only on the basis of the data regarding their quality. Material and Methods. The passive surveillance on adverse events following immunization was conducted simultaneously with immunization campaign against pandemic influenza in the Autonomous Province of Vojvodina. Reporting of adverse events was conducted by health care service through a specially designed questionnaire Results. In the period from December 17th 2009 to February 7th 2010, of the total number of 55720 people who were vaccinated, 50433 received one dose and 5287 received two doses of vaccine. The total number of doses administered was 61007. During the observed period, some adverse reactions were recorded in 37 people, the rate of occurrence of adverse reactions being 6.6 per 10.000 vaccinated. Since the majority of patients had several symptoms and signs, the number of recorded clinical manifestations was much higher (140 than the number of patients with reactions. The dominant symptoms and signs were fever (51.4%, weakness/fatigue (48.6%, headache (40.5% and myalgia (31.5%. The reactions in the majority of patients were mild and transient. Only two patients sought medical care and one was hospitalized. Since the immunization coverage was very small, it was not possible to record rare adverse events, whose expected incidence is, anyway, very low. Conclusion. Surveillance on adverse reaction following immunization represents an important component of immunization program, especially when new vaccines are introduced. Therefore, this form

  1. Adverse reaction of topical etofenamate: petechial eruption.

    Science.gov (United States)

    Orbak, Z; Yildirim, Z K; Sepetci, O; Karakelleoglu, C; Alp, H

    2012-10-01

    Etofenamate is a non-steroidal anti-inflammatory drug (NSAID). Clinical findings caused by etofenamate are uncommon. Allergic contact dermatitis is the most common cutaneous reaction reported. But petechial eruption due to etofenamate had not been reported yet. This report concerns an 11-year old male with petechial eruption after application of topical etofenamate. Physicians need to be aware that patients can develop an asymptomatic purpuric eruption when etofenamate is ordered. PMID:23620980

  2. 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.

  3. 喹诺酮类药物的不良反应报告分析%Analysis of Quinolones Adverse Reaction Reports

    Institute of Scientific and Technical Information of China (English)

    王惠霞; 陆建平

    2012-01-01

      Objective:Explore the occurrence of adverse reactions of quinolones and clinical control measures.Method:A total of 27 cases of quinolone ADR reports collected in our hospital in 2009 were analyzed statistically in respect of patients age and sex,route of administration,drug varieties,organs or systems involved and the clinical manifestation.Result:Lesions of skin and its appendages were the most common damages of quinolone ADR.Conclusion:Importance should be attached to the reporting and monitoring of quinolone ADR reports in the clinic and reduce the incidence of adverse reactions.%  目的:探讨喹诺酮类药物不良反应(ADR)的发生情况与临床控制措施。方法:对笔者所在医院2011年1-12月上报的27例喹诺酮类药物 ADR 报告,按患者年龄、性别、药品类别、ADR 累及器官或系统及临床表现等进行统计、分析。结果:喹诺酮类抗菌药物药物的不良反应临床表现以皮肤及附件损害最多见。结论:临床应重视喹诺酮类药物的不良反应,加强 ADR 监测工作,促进临床合理用药,减少不良反应的发生。

  4. [Analysis of Spontaneously Reported Adverse Events].

    Science.gov (United States)

    Nakamura, Mitsuhiro

    2016-01-01

    Observational study is necessary for the evaluation of drug effectiveness in clinical practice. In recent years, the use of spontaneous reporting systems (SRS) for adverse drug reactions has increased and they have become an important resource for regulatory science. SRS, being the largest and most well-known databases worldwide, are one of the primary tools used for postmarketing surveillance and pharmacovigilance. To analyze SRS, the US Food and Drug Administration Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report Database (JADER) are reviewed. Authorized pharmacovigilance algorithms were used for signal detection, including the reporting odds ratio. An SRS is a passive reporting database and is therefore subject to numerous sources of selection bias, including overreporting, underreporting, and a lack of a denominator. Despite the inherent limitations of spontaneous reporting, SRS databases are a rich resource and data mining index that provide powerful means of identifying potential associations between drugs and their adverse effects. Our results, which are based on the evaluation of SRS databases, provide essential knowledge that could improve our understanding of clinical issues. PMID:27040337

  5. The occurrence of adverse drug reactions reported for attention deficit hyperactivity disorder (ADHD medications in the pediatric population: a qualitative review of empirical studies

    Directory of Open Access Journals (Sweden)

    Aagaard L

    2011-12-01

    Full Text Available Lise Aagaard1-3, Ebba Holme Hansen1-31Department of Pharmacology and Pharmacotherapy, Section for Social Pharmacy, Faculty of Pharmaceutical Sciences, University of Copenhagen, Denmark; 2FKL-Research Centre for Quality in Medicine Use, Copenhagen, Denmark; 3Danish Pharmacovigilance Research Project (DANPREP, Copenhagen, DenmarkBackground: To review empirical studies of adverse drug reactions (ADRs reported to be associated with the use of medications generally licensed for treatment of attention deficit hyperactivity disorder (ADHD symptoms in the pediatric population.Methods: PubMed, Embase, and PsycINFO® databases were searched from origin until June 2011. Studies reporting ADRs from amphetamine derivates, atomoxetine, methylphenidate, and modafinil in children from birth to age 17 were included. Information about ADR reporting rates, age and gender of the child, type, and seriousness of ADRs, setting, study design, ADR assessors, authors, and funding sources were extracted.Results: The review identified 43 studies reporting ADRs associated with medicines for treatment of ADHD in clinical studies covering approximately 7000 children, the majority of 6- to 12-year-old boys, and particularly in the United States of America (USA. The most frequently reported ADRs were decrease in appetite, gastrointestinal pain, and headache. There were wide variations in reported ADR occurrence between studies of similar design, setting, included population, and type of medication. Reported ADRs were primarily assessed by the children/their parents, and very few ADRs were rated as being serious. A large number of children dropped out of studies due to serious ADRs, and therefore, the actual number of serious ADRs from use of psychostimulants is probably higher. A large number of studies were conducted by the same groups of authors and sponsored by the pharmaceutical companies manufacturing the respective medications.Conclusion: Reported ADRs from use of

  6. Adverse reactions associated with aminopenicillins in Indian population.

    Science.gov (United States)

    Grover, J K; Tyagi, D

    1993-07-01

    The overall incidence of adverse drug reactions following ampicillin and amoxicillin administration to 439 and 169 indoor patients of All India Institute of Medical Sciences, New Delhi were 19.13% and 15.5% respectively. Ampicillin produced diarrhoea (7.74%), nausea and vomiting (7.74%) anorexia (5.46%) headache (4.10%) and allergic reactions (2.9%). With amoxicillin, anorexia was observed in 4.79%, epigastric distress in 5.9% headache in 6.58%, coating of tongue in 8.98% and dizziness in 1.79% of patients. Intramuscular route of administration of ampicillin produced least ADRs. Females were more susceptible to adverse reactions of ampicillin and males to amoxicillin. Incidence of ADRs by these two aminopenicillins is less than that reported from abroad. PMID:8276508

  7. Adverse reactions to intravenous iodinated contrast media: a prospective study

    Directory of Open Access Journals (Sweden)

    Dhruv J. Modi

    2012-06-01

    Full Text Available Background: Adverse reactions to intravenous iodinated contrast media may be classified as general and organ-specific, such as contrast-induced nephrotoxicity. General adverse reactions may be sub classified into acute and delayed types. Acute general adverse reactions can range from transient minor reactions to life-threatening severe reactions. This study was done to determine clinical adverse effects of the iodinated contrast media. Methods: Data of 899 consecutive patients at C.U. Shah Medical College and Hospital, Surendranagar, who received sodium meglumine diatrizoate intravenous iodinated contrast media during the period of May 2011 to April 2012, were collected for any adverse drug reactions. Results: Out of 899, 189 patients developed adverse contrast reactions. The incidences of mild, moderate and severe adverse reactions were 19.47%, 1.33% and 0.28%, respectively. There were no differences in the incidence of adverse reactions according to gender (males 21.1%; females 20.7%; p= >0.05 or age (p= >0.05. The incidence of adverse reactions was significantly higher in patients with a history of previous reactions (50% than in those with no history (21.25%; p= <0.05. Conclusions: The skin was the most commonly affected site of reactions. In reactions, mild forms were more common compared to moderate and severe. [Int J Basic Clin Pharmacol 2012; 1(3.000: 211-215

  8. Study and evaluation of the various cutaneous adverse drug reactions in Kasturba hospital, Manipal

    OpenAIRE

    Ghosh S; Acharya Leelavathi; Rao Padma

    2006-01-01

    The present study emphasizes on implementation of the adverse drug reaction reporting and monitoring system, in the Dermatology department of Kasturba Hospital, Manipal, by a clinical pharmacist, using different promotional activities. Documented adverse drug reactions were assessed and analyzed for incidence, purpose of visit, types, drug classes, individual drug causing adverse drug reactions, type of cutaneous reaction, and various predisposing factors. Management and outcome of the advers...

  9. DEVELOPMENT OF ADVERSE DRUG REACTION REPORTING CULTURE IN SECOND PROFESSIONAL MEDICAL UNDERGRADUATES AT TERTIARY CARE TEACHING HOSPITAL: A HEALTH IMPERATIVE

    OpenAIRE

    Deepak; Gitanjali; Rangeel Singh; Priyanka; Heenopama; Adit; Hemant Kumar

    2014-01-01

    BACKGROUND: Due to under reporting of ADRs by clinicians, second professional medical under graduates were sensitized about ADR reporting. METHODS: ‘Sensitization of Medical Under graduates for ADR Reporting’ (SMUAR Model) was introduced for promoting ADR notification by clinicians. One year prospective study was carried out in a tertiary care hospital with the help of 2nd Prof MBBS students. The students were asked to collect ADRs from clinical departments. Group of eight...

  10. 避孕药具不良反应监测报告分析%Analysis of monitoring report for contraceptive adverse reactions ZHONG

    Institute of Scientific and Technical Information of China (English)

    钟如玉

    2015-01-01

    Objective To analyze monitoring report for contraceptive adverse reactions, and to provide reference for clinical choice of appropriate contraceptive and development of family planning work. Methods There were 51802 people using contraceptive as study subjects, and analysis was made on monitoring report for their contraceptive adverse reactions. Results A total of 51802 cases of contraceptive were provided with follow-up in 50766 cases as 98.0%. There were 9260 cases of short-term effect oral contraceptive, 128 cases of emergency contraceptive, 16002 cases of nonoxinol external contraceptive, 24564 cases of male condoms, 192 cases of contraceptive foam, and 620 cases of intra uterine device (IUD). Follow-up showed that there were 124 cases with contraceptive adverse reactions of these contraceptives, except male condoms and contraceptive foam. Conclusion Contraceptive has an important role in family planning, while its adverse reactions have influence on clinical effect. Monitoring and follow-up of contraceptive can provide timely information of various contraceptives. Timely judgment and clinical treatment can be applied, thus clinical effects of contraceptives can be improved, and users’safety can also be ensured.%目的:对避孕药具不良反应监测报告进行分析,为临床选取合适的避孕药具提供依据,同时为临床开展计划生育工作提供参考。方法51802例使用避孕药具人员为研究对象,对其不良反应监测报告进行分析。结果共发放避孕药具51802例,随访50766例,随访率为98.0%。其中包括发放短效口服避孕药9260例,紧急避孕药128例,壬苯醇醚外用避孕药16002例,男用安全套24564例,隐形避孕套192例,节育环(IUD)620例,随访过程中发现避孕药具不良反应124例,除男用避孕套、女用隐形避孕套在随访过程中未发现明显的不良反应外,其余均出现不同的不良反应。结论避孕药具是落实节育措施的

  11. Spontaneous adverse drug reaction monitoring in oncology: Our experience

    Directory of Open Access Journals (Sweden)

    K Kaur

    2015-01-01

    Full Text Available Background: Adverse drug reaction (ADR monitoring is slowly developing as an important aspect of healthcare. The aim of the study was to study the pattern of adverse drug reactions in the Oncology department of a tertiary care hospital. Materials And Methods: This was a prospective study conducted in the Oncology department of a tertiary care hospital in which ADRs were reported spontaneously. The ADRs were noted from 1st January, 2007 to 30th June, 2011. Following were noted: demographics, premedication (if any, diagnosis, chemotherapy (regimen, cycles, medication history, and alteration in the treatment or co morbidities, ADRs (severity and management. Adverse drug reactions were noted by patient interview, collaborating with information on file, recording changes in the prescribing chart and investigations, consulting the doctor on duty. Results: During this study period, there were total of 14,475 visits of patients from which 2500 ADRs were recorded. Maximum number of ADRs were noted with platinum compounds (25.52% followed by pyrimidine antagonists (19.88%. The most common malignancy reported in our hospital was Carcinoma breast (20% followed by leukemia (12% and Ca ovary (12%. Alopecia (27.76% was the most common ADR followed by anemia (7.48%, thrombocytopenia (6.96% and constipation (6.16%. Conclusion: Alopecia is the most common ADR and platinum compounds were responsible for the maximum number of ADRs. The most common carcinoma reported during this period was carcinoma breast.

  12. Polysymptomatic syndromes and autonomic reactivity to nonfood stressors in individuals with self-reported adverse food reactions.

    Science.gov (United States)

    Bell, I R; Markley, E J; King, D S; Asher, S; Marby, D; Kayne, H; Greenwald, M; Ogar, D A; Margen, S

    1993-06-01

    This study compared symptom reports and cardiovascular reactivity of a group of 24 individuals recruited from the community who reported a cognitive or emotional symptom caused by at least one food (food-sensitivity reporters, FSR) vs those of 15 controls (C) without a history of food, chemical, drug, or inhalant sensitivities. The main findings were: 1) FSR indicated sensitivities not only to foods, but also to environmental chemicals, drugs, and natural inhalants, as well as significantly more symptoms than C in multiple systems; 2) more FSR than C noted recent state depression and anxiety, as well as higher trait anxiety on the Bendig form of the Taylor Manifest Anxiety Scale; 3) however, on multiple regression analysis, not only depression, but also the number of sensitivities (foods, chemicals, drugs, inhalants), accounted for part of the variance in total number of symptoms (38 and 17%, respectively), whereas none of the affective measures accounted for any of the variance in total number of sensitivities over all subjects; 4) after controlling for depression and anxiety, FSR still showed a trend toward poorer performance on a timed mental arithmetic task (p = 0.16); and 5) FSR and C showed opposite patterns of heart rate change to two different stressful tasks (mental arithmetic and isometric exercise) (group by task interaction, p foods, chemicals, drugs, and inhalants) and for salient psychological stress in the expression of psychophysiological dysfunctions of FSR. As in other chronically ill populations, negative affect in food-sensitive individuals may explain greater symptom reporting, but not necessarily account for the illness itself. For either a food or a psychological stimulus to begin to elicit sensitized responses, e.g., marked physiological differences from C, FSR may require multiple, intermittent exposures spaced over 5-28 days rather than on only 1 day. PMID:8409077

  13. Educational intervention to improve physician reporting of adverse drug reactions (ADRs in a primary care setting in complementary and alternative medicine

    Directory of Open Access Journals (Sweden)

    Ostermann Thomas

    2009-07-01

    Full Text Available Abstract Background Recent studies have shown that adverse drug reactions (ADRs are underreported. This may be particularly true of ADRs associated with complementary and alternative medicine (CAM. Data on CAM-related ADRs, however, are sparse. Objective was to evaluate the impact of an educational intervention and monitoring programme designed to improve physician reporting of ADRs in a primary care setting. Methods A prospective multicentre study with 38 primary care practitioners specialized in CAM was conducted from January 2004 through June 2007. After 21 month all physicians received an educational intervention in terms of face-to-face training to assist them in classifying and reporting ADRs. The study centre monitored the quantity and quality of ADR reports and analysed the results. To measure changes in the ADR reporting rate, the median number of ADR reports and interquartile range (IQR were calculated before and after the educational intervention. The pre-intervention and post-intervention quality of the reports was assessed in terms of changes in the completeness of data provided for obligatory items. Interrater reliability between the physicians and the study centre was calculated using Cohen's kappa with a 95% confidence interval (CI. We used Mann Whitney U-test for testing continuous data and chi-square test was used for categorical data. The level of statistical significance was set at P Results A total of 404 ADRs were reported during the complete study period. An initial 148% increase (P = 0.001 in the number of ADR reports was observed after the educational intervention. Compared to baseline the postinterventional number of ADR reportings was statistically significant higher (P P Conclusion The results of the present study demonstrate that an educational intervention can increase physician awareness of ADRs. Participating physicians were able to incorporate the knowledge they had gained from face-to-face training into their

  14. Amitriptyline adverse reactions reported by outpatients / Reacciones adversas a amitriptilina relatadas por pacientes ambulatoriales / Reações adversas a amitriptilina relatadas por pacientes ambulatoriais

    Directory of Open Access Journals (Sweden)

    Sebastião ECO

    2005-04-01

    Full Text Available Aim: The aim of the present study was to know the profile of adverse drug reactions (ADR, at ambulatory level, suffered by patients using amitrityline. Method: After an informed consent, 130 randomly chosen patients using pharmacy services from eight different health units in Riberão Preto - São Paulo (Brazil were interviewed. To gather socioeconomic, clinical data and ADR, an structured questionnaire was used. The latter were analyzed regarding their seriousness, frequency, causality and preventability. Results: All surveyed patients reported at least one ADR to amitriptyline, being doubtful (4%, possible (44% and probable (52%. From probable/possible, 29% were reported as moderate/serious, and among them, 67% were frequent. 79% of total ADR were considered as preventable. 5 more cited symptoms (29.5% were: dry mouth or taste disturbances, drowsiness, orthostatic hypotension and weakness. Conclusions: Reported amitriptylin ADRs could have been prevented or reduced their seriousness, or, at least, advised when occurring, because they may produce other drug-related problems, non-compliance or discomfort. Patients should be taken into account as ADR information sources, improving physician-patient relationship and their quality of life by improving medical care.

  15. CDC Wonder Vaccine Adverse Event Reporting System

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Vaccine Adverse Event Reporting System (VAERS) online database on CDC WONDER provides counts and percentages of adverse event case reports after vaccination,...

  16. [Adverse reaction induced by licorice preparations: clinical analysis of 93 cases].

    Science.gov (United States)

    Mao, Min; Li, Wei; Wang, Wei; Wang, Shu-Xia; Lu, Jin; Chang, Zhang-Fu

    2013-11-01

    Licorice is a traditional Chinese medicine commonly used in clinic. The products,what contain licorice or licorice extract, has early been involved in the field of cosmetics except for the field of pharmaceuticals and food. Consequently, the reporting on adverse reactions induced by licorice preparations are more frequent. Based on the clinical data of licorice preparations adverse reactions, we described the characteristics of the licorice-related adverse reactions, and proposed specific measures to reduce the incidence of adverse reactions, provided a reference for the rational use of licorice preparations. PMID:24494570

  17. Acute adverse reactions to magnetic resonance contrast media--gadolinium chelates.

    Science.gov (United States)

    Li, A; Wong, C S; Wong, M K; Lee, C M; Au Yeung, M C

    2006-05-01

    The objective of this study was to evaluate the clinical safety of intravenous gadolinium-based contrast media used in patients who underwent MRI at a single institution. Acute adverse reactions to intravenous gadolinium-based contrast media used for MRI at the Princess Margaret Hospital, Hong Kong, SAR, from January 1999 to November 2004 were recorded in an incidence log book. The medical records of patients' demographics were retrospectively reviewed and the nature, frequency and severity of the adverse reactions were investigated and documented. The incidence of acute adverse reactions to intravenous gadolinium-based contrast media was 0.48% (45 patients with 46 adverse reactions). The severity of these adverse reactions were 96% mild, 2% moderate (one patient developed shortness of breath that required oxygen supplementation and intravenous steroidal management) and 2% severe (one patient developed an anaphylactoid reaction, but successfully recovered through timely resuscitation). No patients were recorded as having contrast extravasation and none died as a result of any adverse reaction. Among the 45 patients who developed adverse reactions, three patients (6.7%) had prior adverse reactions to iodinated contrast media, three (6.7%) had prior reactions to a different gadolinium-based contrast agent, one (2%) had asthma and nine (20%) had a history of drug/food allergy. Overall, 41% of the adverse reactions were not documented in the final MRI report or the clinical medical records. Gadolinium-based contrast media are safe and well tolerated by the vast majority of patients. In our study, the adverse reaction rate (0.48%) and the incidence of severe anaphylactoid reaction (0.01%) concur with those reported in the literature. Although most of the symptoms are mild and transient, these adverse reactions must be accurately documented and managed. PMID:16632615

  18. EDITORIAL ADVERSE DRUG REACTIONS: A MULTIFORM PATHOLOGY RESPONSABILITY OF MANY

    OpenAIRE

    Joan-Ramon Laporte

    2009-01-01

    Possibly still are health professionals that when hearing about adverse drug reactions only think in cutaneous rash, blood dyscrasias, anaphylactic shock and congenital malformations. The mentioned adverse effects are real, but relatively infrequent. Furthermore, are unexpected, not related with the pharmacological mechanism of action, unpredictable and dose independent. These adverse drug reactions are like a therapeutic lottery, depending on «luck».However, when the pharmacological patholog...

  19. The role of Clinical Pharmacists in the improvement of a pharmacovigilance system: A review of the reported adverse drug reactions during 2004-2010 in Mazandaran Province of Iran

    Directory of Open Access Journals (Sweden)

    Elham Azhdari

    2013-02-01

    Full Text Available Background: Following establishment of Iranian Adverse Drug Reaction (ADR Monitoring Center in 1997, ADR committees were established in all hospitals of Mazandaran Province of Iran. Clinical pharmacists from Mazandaran University of Medical Sciences have been involved with these committees since 2007. The aim of this study was to compare the results of the pharmacovigilance system before and after active involvement of clinical pharmacists. Methods: This study included Yellow Cards filled out by healthcare providers in Mazandaran Province during 2004-2010. Frequency of Adverse Drug Reactions (ADRs, route of administration, reporters, number of reports in each years and damaged organs were focuses. Statistical analysis was performed by SPSS 16 software. P Results: A total of 793 yellow cards were completed during 2004 – 2010. Only 38 ADRs (4.8% were related to 2004-2007. Most of the reports generated by Nurses (49.3% followed by Pharmacists and Physicians (P Conclusion: Clinical pharmacists’ intervention regarding establishing ADR committees in the hospitals improved the output of the pharmacovigilance system, although under-reporting is still a major drawback of spontaneous reporting. Keywords: Pharmacovigilance, Adverse Drug Reaction, Mazandaran, Adverse Drug Reaction Reporting Systems

  20. 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 to....... Low-income countries reported relatively more ADRs for antiinfectives for systemic use than high-income countries, and high-income countries reported more ADRs for antineoplastic and immunomodulating agents than lower-income groups. Conclusion: This study showed that high-income countries had the...... 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...

  1. Precautions and Adverse Reactions during Blood Transfusion

    Science.gov (United States)

    ... fever and need another transfusion may be given acetaminophen before the next transfusion. Allergic reactions Symptoms of an allergic reaction include itching, a widespread rash, swelling, dizziness, and headache. Less common symptoms are breathing difficulties, ...

  2. 171例严重药品不良反应报告分析%ADR Report Analysis of 171 Cases of Serious Adverse Drug Reactions

    Institute of Scientific and Technical Information of China (English)

    文加勇; 张万智; 唐晓霞

    2015-01-01

    目的:了解严重药品不良反应(ADR)的发生特点,为ADR监测工作提供参考。方法:提取国家ADR监测系统中2011-2013年孝感市上报的ADR严重病例报告171份,对报告来源、患者性别、药品种类、给药途径、ADR累及器官/系统等进行分析。结果:严重ADR报告率与年龄因素和性别因素有关,且儿童和老年人高于中青年人(P <0.05),女性高于男性(男女之比为1∶1.44, P <0.05);171份严重 ADR 报告中,抗感染药(78,45.62%)、维生素、营养药、调节水电解质和酸碱平衡药(37,21.64%)和中药注射剂(15,8.77%)位居前三;静脉滴注给药125例(73.09%),口服给药26例(15.20%);过敏性反应82例(47.95%),皮肤及附件损害36例(21.05%)。结论:2011-2013年孝感市严重ADR高发于女性、儿童和老年人用药、抗感染药物和静脉滴注给药,在ADR监测中应引起注意。%ABSTRACTObjective:To investigate the characteristics of serious adverse drug reactions(ADRs)so as to pro-vide a reference for ADR monitoring.Methods:The reports of 171 cases of severe ADRs submitted by Xiaogan city from 2011 to 2013 were extracted from the National Adverse Drug Reaction Monitoring System. The data was analyzed such as the source of report, patient sex, drug species, route of administration and ADR involving or-gans/systems.Results:The serious ADR reporting rate was associated with age and gender factors, serious ADRs in children and the elderly were higher than young and middle-aged people(P<0.05)and higher in women than in men(the ratio of male to female was 1∶1.44,P<0.05). In 171 cases of severe ADRs, 78 cases(45.62%) ever used anti-infective drugs, 37 cases(21.64%)used Vitamins, nutritional supplements and the drugs of regulat-ing water-electrolyte and acid-base balance, and 15 cases(8.77%)were given traditional Chinese medicine injec-tions. About 125 cases(73.09%)received intravenous

  3. [Chinese medicine adverse reactions' literature statistical analysis in recent five years].

    Science.gov (United States)

    Xiang, Fei; Zhang, Xiaogang

    2011-10-01

    Since the state food and drug administration (SFDA) issued the first edition of adverse drug reaction(ADR) information in November, 2001, it has 32 edition, reported the drug 66 species of adverse reactions, involving the variety of 12 traditional Chinese medicines, it was effectively reminds all social concern of adverse drug reaction. For statistical analysis in recent years reported adverse drug reaction of prepared Chinese medicine, collected 462 literatures from 2005-09 CNKI Chinese journal full-text database of medicine health directory. In all the collections, about 94 literatures are closely related to adverse drug reaction report of prepared Chinese medicine. But there are only 7 references could identify traditional Chinese medicine and western medicine correctly in 72 literatures with the value of statistical analysis. That means only 8.9% of literatures can correctly identify western medicine and Chinese traditional medicine. So it proved that TCM workers' knowledge of ADR remains to be greatly improved. PMID:22242443

  4. Frequency of adverse reactions to radiopharmaceuticals in Europe

    International Nuclear Information System (INIS)

    A prospective survey was performed in 17 nuclear medicine departments during 1996 in an attempt to provide reliable data on the prevalence of adverse reactions to radiopharmaceuticals. All adverse events following radiopharmaceutical administration were recorded, irrespective of the severity or likelihood of causality, and subsequently analysed using an algorithm developed by Silberstein et al., designed to establish a cause-effect relationship. A prevalence of 11 events per 105administrations was obtained (95% confidence limits 3.3-19.2). No serious of life-threatening events were reported. This rate is slightly higher than that obtained in a larger scale study in the United States (2.3 events per 10 5administrations, 95% confidence limits 1.2-3.4). The difference may be due to the decision to include or exclude vasovagal events from the analysis, the way in which the algorithm was used and the comparative size and time scale of the two studies. The prevalence of adverse reactions is approximately 1000-fold than less that occurring with iodinated contrast media and drugs. (orig.). With 2 tabs

  5. 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...

  6. A study of adverse drug reactions in pediatric patients

    Directory of Open Access Journals (Sweden)

    R Priyadharsini

    2011-01-01

    Full Text Available Aim: To study the adverse drug reaction (ADR pattern in a pediatric population in a tertiary care hospital. Materials and Methods: An observational study was done in the department of pediatrics in a tertiary care hospital. The ADRs occurring in the inpatient wards and outpatient department of pediatrics were actively monitored. The collected reports were analyzed for ADR pattern, drug groups, demographic profile, causality, severity, and preventability of the ADR. Results: A total of 30 ADRs were documented during the mid period of 2009 among pediatric patients. Most of the ADRs (60% occurred below the age of 1 year. Antibiotics comprised the major group of drugs causing ADRs (67%. Rashes and urticaria were the most common type of ADR (37% followed by fever, anaphylactic shock, vomiting, chills, and rigors. A single case of death had been reported in the study period. There were more occurrences of ADRs with multiple drugs compared to single drug therapy. About 80% of the ADRs were of probable causality and 87% were of probable preventability. There were no mild reactions, with 77% of reactions being moderate and 23% of reactions being severe in the severity scale. Conclusions: ADRs occur more among infants and antibiotics were more commonly implicated. Most of the reactions were of moderate severity. This indicates the need for a rigid ADR monitoring among pediatric patients to ensure safety of drug therapy.

  7. Adverse Drug Reactions Reported in Our Hospital: Analysis of 560 Cases%我院560例药品不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    张夏华; 吴广通; 石玉岚; 米丽

    2009-01-01

    To probe into the status quo and characteristics of the adverse drug reactions (ADR) occurred in our hospital. METHODS: A total of 560 ADR cases collected in our hospital from 2004 to 2008 were analyzed statistically in respect of patients' age and sex, drug varieties, route of administration and clinical manifestation, etc. RESULTS: Of all the ADR cases reported in our hospital, 51.8% were induced by anti-infective drugs vs. 10.7% by traditional Chinese medicines; 51.8% manifested as lesions of skin and its appendants, but none of them died. CONCLUSION: Clinical importance should be attached to the monitoring of ADR, the indications of the anti-infective drugs and traditional Chinese medicines should be strictly followed in order to decrease the incidence of ADR.%目的:了解我院药品不良反应(ADR)的发生情况及特点.方法:将我院2004~2008年收集的ADR报告560例,按患者性别、年龄、涉及药品种类、给药途径、临床表现等进行统计、分析.结果:在我院上报的ADR中,抗感染药引发的ADR占51.8%,中药制剂占10.7%;ADR类型以皮肤及其附件损伤最常见,占51.8%,无死亡病例报道.结论:临床应加强ADR监测工作,尤其要严格把握抗感染药及中成药的使用指征,减少ADR的发生.

  8. 邢台市人民医院2009年药物不良反应报告分析%Analysis of adverse drug reaction report of Xingtai People' hospital in 2009

    Institute of Scientific and Technical Information of China (English)

    李福秀

    2012-01-01

    目的 通过对某院药物不良反应报告的分析和讨论,为临床安全用药提供参考.方法 对该院2009年度上报的120例不良反应报告进行收集、汇总、统计分析.结果 药物不良反应报告主要来源于医疗机构,涉及药物不良反应的药品中抗感染药居首位,给药途径以静脉滴注为主.不良反应主要累及消化系统,皮肤及其附件.结论 应加强和重视药品不良反应的检测,保障公众安全合理用药.%OBJECTIVE To analyze and discuss the adverse drug reactions of Xingtai people' hospital and refer to the clinical medication safety. METHODS We collected summarized and analyzed the adverse drug reactions with 120 patients in 2009. RESULTS The adverse drug reaction report mainly derives from medical institution. The adverse drug reactions in our hospital were chiefly caused by antiinfectives, which the primary route of administration was intravenous drip. The major adverse reaction involved the digestive system, skin and its appendage. CONCLUSION We should strengthen and attach importance to the adverse drug reaction in order to guarantee the public to use drug safely and reasonably.

  9. Assessment of adverse drug reactions based on spontaneous signals at secondary care public hospital

    Directory of Open Access Journals (Sweden)

    S Ponnusankar

    2015-01-01

    Full Text Available Adverse drug reactions are considered to be among the leading causes of morbidity and mortality. Approximately 5-25% of hospital admissions are due to adverse drug reactions and 6-15% of hospitalized patients experience serious adverse drug reactions, causing significant prolongation of hospital stay. Thus this study was aimed at determining adverse drug reactions by conducting spontaneous reporting in secondary care Govt. District Head Quarters Hospital at Ooty. A prospective Spontaneous Adverse Drug Reaction reporting study was conducted over a period of 12 months from July 2012 to June 2013. The assessment, categorization, causality, severity and preventability were assessed using standard criteria. A total of 47 suspected adverse drug reactions were reported during the study period. Over all incidences was 1.29% among the study population. Antibiotics (31.91% were the class of drug most commonly involved, while ciprofloxacin (14.89% was the most frequently reported. Type H (Hypersensitivity reactions (51.06% accounted for majority of the reports and a greater share of the adverse drug reactions are probable (89.36% based on causality assessment. Mild reactions accounted 82.97% based on modified Hartwig and Siegel severity scale. In 76.59% of the reports, the reaction was considered to be preventable based on Schumock and Thornton preventability scale. The implementation of monitoring based on spontaneous reporting will be useful for the detection and evaluation is associated with increase in morbidity and duration of hospitalization. This study also has established the vital role of clinical pharmacist in the adverse drug reaction monitoring program.

  10. Prevalence of adverse drug reactions at a private tertiary care hospital in south India

    Directory of Open Access Journals (Sweden)

    Shanmugam Sriram

    2011-01-01

    Conclusions: Measures to improve detection and reporting of adverse drug reactions by all health care professionals is recommended to be undertaken, to ensure, and improve patient′s safety. In this way, hospital/clinical pharmacists play the cornerstone role.

  11. Analysis of adverse drug reactions:on 93 cases report%药品不良反应93例分析

    Institute of Scientific and Technical Information of China (English)

    罗卿春

    2016-01-01

    目的:了解我院药品不良反应发生的特点及其引发的相关因素,为临床安全、合理用药提供依据。方法对该院2014年度收集上报的93例 ADR 报告进行回顾性分析。结果 ADR 93例,男性高于女性,50岁以上人群所占比例高于其他年龄段;引起 ADR 的因素以抗菌药物使用最高,占56.99%,其中又以β-内酰胺类居首,24例,占45.28%;损害器官、系统以皮肤及附件为主,引发 ADR 类型以一般药品不良反应为主,占94.62%。结论药品不良反应的发生与年龄、联合用药等因素有关,应加强 ADR 监测和报告工作,指导临床合理用药,减少药品不良反应的发生。%Objective To investigate the characteristics and the predisposing factors of adverse drug reactions(ADR) occurred in our hospital,the safety and rational use of drugs may be provided. Methods Analyzed 93 cases of ADRs,collected from a retrospective survey,in our hospital in 2014. Results Among 93 cases of ADRs,the male was more than the female in the ratio,proportion of people over the age of 50 was higher than other age groups;The incidence of ADR cases was mainly in-duced by the antimicrobial drugs,accounted for 56. 99% ,among which the cases that caused by β-lactamase antibiotics were acounted for the most(24cases,45. 28% );system-organ damages were common in skin and appendixes,the conventional ADR was most in the predisposing types of ADRs,accounting for 94. 62% . Conclusion Occurrence rate of ADR relates to the dis-tribution of patient age and approach of using drug. We should strengthen the monitoring and reporting work,in order to promote the rational drug use,and reduce ADRs.

  12. Mining Adverse Drug Reactions from online healthcare forums using Hidden Markov Model

    OpenAIRE

    Sampathkumar, Hariprasad; Chen, Xue-Wen; Luo, Bo

    2014-01-01

    Background Adverse Drug Reactions are one of the leading causes of injury or death among patients undergoing medical treatments. Not all Adverse Drug Reactions are identified before a drug is made available in the market. Current post-marketing drug surveillance methods, which are based purely on voluntary spontaneous reports, are unable to provide the early indications necessary to prevent the occurrence of such injuries or fatalities. The objective of this research is to extract reports of ...

  13. 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...

  14. 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.

  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. Linking Drugs to Obscure Illnesses: Lessons from Pure Red Cell Aplasia, Nephrogenic Systemic Fibrosis, and Reye’s Syndrome. A Report From the Southern Network on Adverse Reactions (SONAR)

    OpenAIRE

    Bennett, Charles L.; Starko, Karen M.; Thomsen, Henrik S; Cowper, Shawn; Sartor, Oliver; Macdougall, Iain C.; Qureshi, Zaina P; Bookstaver, P. Brandon; Miller, April D; Norris, LeAnn B.; Xirasagar, Sudha; Trenery, Alyssa; Lopez, Isaac; Kahn, Adam; Murday, Alanna

    2012-01-01

    Identification of serious adverse drug reactions (sADRS) associated with commonly used drugs can elude detection for years. Reye’s syndrome (RS), nephrogenic systemic fibrosis (NSF), and pure red cell aplasia (PRCA) among chronic kidney disease (CKD) patients were recognized in 1951, 2000, and 1998, respectively. Reports associating these syndromes with aspirin, gadodiamide, and epoetin, were published 29, 6, and 4 years later, respectively. We obtained primary information from clinicians who...

  17. Epidemiology and prevention of adverse drug reactions in the elderly

    Institute of Scientific and Technical Information of China (English)

    Lexin WANG

    2005-01-01

    Many studies have demonstrated a correlation between increasing age and adverse drug reactions. This increased risk is related to aged-related changes in pharmacokinetics and pharmacodynamics. In addition, chronic illnesses such as congestive heart failure, coronary artery disease and hypertension are more prevalent in the elderly who also have an increased risk of diabetes, arthritis and cancer. Consequently elderly patients are often treated with multiple medications, which may cause drug interactions and adverse drug reactions. Adequate undergraduate training in clinical pharmacology and continued professional development in evidence-based therapeutics will undoubtedly reduce inappropriate prescribing and improve the quality of medications. Good communications between physicians and patients are also critically important in avoidance or prevention of adverse drug reactions in the elderly.

  18. Standardizing adverse drug event reporting data

    OpenAIRE

    Wang, Liwei; Jiang, Guoqian; Li, Dingcheng; Liu, Hongfang

    2014-01-01

    Background The Adverse Event Reporting System (AERS) is an FDA database providing rich information on voluntary reports of adverse drug events (ADEs). Normalizing data in the AERS would improve the mining capacity of the AERS for drug safety signal detection and promote semantic interoperability between the AERS and other data sources. In this study, we normalize the AERS and build a publicly available normalized ADE data source. The drug information in the AERS is normalized to RxNorm, a sta...

  19. Adverse reactions to tattoos: a study from the hilly region in northern India

    OpenAIRE

    Subhash Kashyap; Ajay Kumar

    2016-01-01

    Background: Body art in the form of ornamental tattoos has been prevalent since ages and is followed with increased popularity in modern times. Tattoo prevalence ranges from 8.5% to 24%, higher among younger ages. Two third of such people who ever had a tattoo reported of being regretted of having a tattoo itself while 2% have adverse reactions. The aim was to study the adverse reaction to tattoos and histological variants in the chronic tattoos. Methods: An observational prospective stud...

  20. 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

    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......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...

  1. 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. PMID:26934738

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

    Directory of Open Access Journals (Sweden)

    Pierandrea Rende

    2013-01-01

    Full Text Available 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.

  3. Cutaneous adverse drug reactions in dogs treated with antiepileptic drugs

    Directory of Open Access Journals (Sweden)

    Tina eKoch

    2016-04-01

    Full Text Available Epilepsy is one of the most common neurologic disorders in dogs and life-long treatment with antiepileptic drugs (AED is frequently required. Adverse events of antiepileptic drugs targeting the skin are only rarely reported in veterinary medicine and the true incidence and spectrum of cutaneous reactions in epileptic dogs remains unknown. In this study we hypothesized that cutaneous reactions commonly occur in epileptic dogs and are related to AED treatment. A retrospective case review of 185 dogs treated for epilepsy identified 20.0% with simultaneous appearance of dermatologic signs. In a subsequent prospective case investigation (n=137 we identified newly appearing or distinct worsening of skin lesions following initiation of antiepileptic drug therapy in 10.9% of dogs treated for epilepsy (95% CI 6.8- 17.7%. Cutaneous lesions were classified as probably drug-induced in 40.0% of these cases. Patch-testing and intradermal testing was further investigated as potential diagnostic methods to confirm antiepileptic drug hypersensitivity. They were of high specificity but sensitivity and positive predictive value appeared inappropriate to recommend their routine use in clinical practice.

  4. Adverse reactions to cosmetics and methods of testing

    OpenAIRE

    Nigam P

    2009-01-01

    Untoward reactions to cosmetics, toiletries, and topical applications are the commonest single reason for hospital referrals with allergic contact dermatitis. In most cases, these are only mild or transient and most reactions being irritant rather than allergic in nature. Various adverse effects may occur in the form of acute toxicity, percutaneous absorption, skin irritation, eye irritation, skin sensitization and photosensitization, subchronic toxicity, mutagenicity/genotoxicity, and photot...

  5. 114例儿童药品不良反应报告分析%Analysis of 114 Pediatric Adverse Drug Reaction Reports in Our Hospital

    Institute of Scientific and Technical Information of China (English)

    李榕; 陈崇泽

    2011-01-01

    Objective:To investigate the adverse drug reactions that occurred in children. Methods: The ages, sex, drug usage, main manifestation, time of occurrence and level of severity of ADR were analyzed in 114 cases of children aged from 2 month to 15 years old. Results: Among 114 cases, 78 patients were male, 36 patients were female. There were fifty three drugs involved. Antibiotics held the first position (42. 11%) and the next was Chinese Anti-inffectives (25. 44%). The main manifestation of ADR was rash, anaphylactoid reaction and somnolence. The main route of administration was intravenous drip. Conclusions: Monitoring of ADR in children should be strengthened in order to ensure the safety of drug usage.%目的:了解儿童发生药品不良反应(ADR)的情况.方法:按患者的年龄、性别、用药情况及ADR的主要表现、发生时间、严重程度等进行统计分析.结果:114例ADR报告中,男78例,女36例,涉及药品53种,主要为抗感染药物(42.11%),其次为中药抗感染药物(25.44%).ADR主要表现是皮疹,其次是过敏样反应、嗜睡.主要给药途径是静脉滴注.结论:应加强对儿童ADR的监测工作,以保证用药安全.

  6. Adverse reactions in treatment with lithium carbonate and haloperidol.

    Science.gov (United States)

    Baastrup, P C; Hollnagel, P; Sorensen, R; Schou, M

    1976-12-01

    Hospital records of 425 patients who had been treated simultaneously with lithium carbonate and haloperidol were examined. Adverse reactions in these patients were the same as in patients given lithium alone or haloperidol alone. None of the patients developed a syndrome resembling that described by others in patients treated with a lithium and haloperidol combination. PMID:1036539

  7. Adverse drug reactions to contrast media in routine clinical practice

    International Nuclear Information System (INIS)

    In a multicenter trial over a 4-year period, three different contrast medium strategies were used in consecutive patients undergoing intravenous urography or CT. The first included ionic agents only; subsequently, iohexol (Omnipaque) or ionic agents plus two doses of oral steroid premedication were studied to compare the incidence and severity of adverse drug reactions. The results are presented in the paper

  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...

  9. 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.

  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

    skin tests (patch 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......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 other drug-induced skin reactions. To reduce the risk of repeat reactions avoidance of the relevant CM and any cross-reacting agents identified by skin testing is recommended....

  11. An overview on adverse drug reactions to traditional Chinese medicines.

    Science.gov (United States)

    Chan, Kelvin; Zhang, Hongwei; Lin, Zhi-Xiu

    2015-10-01

    The safe use of Chinese materia medica (CMM) and products in traditional Chinese medicine (TCM) practice conventionally relies on correct pharmacognostic identification, good agricultural and manufacturing practices based on pharmacopoeia standards and rational/correct CMM combinations with TCM-guided clinical prescribing. These experience-based principles may not absolutely ensure safety without careful toxicological investigations when compared with development of new pharmaceutical drugs. Clinically observed toxicity reports remain as guidance for gathering toxicological evidence, though essential as pharmacovigilance, but are considered as late events for ensuring safety. The overview focuses on the following factors: global development of TCM that has affected conventional healthcare; examples of key toxic substances in CMM; reported adverse drug reactions (ADRs) consequential to taking CMM and TCM products; and proposals on rational approaches to integrate the knowledge of biomedical science and the principles of TCM practice for detecting early ADRs if both TCM products and orthodox drugs are involved. It is envisaged that good control of the quality and standards of CMM and proprietary Chinese medicines can certainly reduce the incidence of ADRs in TCM practice when these medications are used. PMID:25619530

  12. Chemotherapy-induced adverse drug reactions in oncology patients: A prospective observational survey

    OpenAIRE

    Deepti Chopra; Rehan, Harmeet S.; Vibha Sharma; Ritu Mishra

    2016-01-01

    Background: Chemotherapy, a multimodal approach to oncological treatment, involves highly complex regimens and hence accounts to high susceptibility toward adverse drug reactions (ADRs). The present study aims to determine the prevalence of adverse events in patients treated with chemotherapy. Materials and Methods: Spontaneous ADR report of patients on antineoplastic drugs received in the past 2 years (January 2011-January 2013) were studied. These reports were analyzed for various carcinoma...

  13. 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

    2016-01-01

    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 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 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.

  14. 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. PMID:19745239

  15. The Severe Adverse Reaction to Vitamin K1 Injection Is Anaphylactoid Reaction but Not Anaphylaxis

    OpenAIRE

    Mi, Yan-Ni; Ping, Na-Na; Xiao, Xue; Zhu, Yan-Bing; Liu, Jing; Cao, Yong-xiao

    2014-01-01

    The severe adverse reaction to vitamin K1 injection is always remarkable and is thought to result from anaphylaxis. Paradoxically, however, some patients administered vitamin K1 injection for the first time have adverse reactions. Using beagle dogs, the present study tested the hypothesis that the response to vitamin K1 is an anaphylactoid reaction. The results showed that serious anaphylaxis-like symptoms appeared in beagle dogs after the administration of vitamin K1 injection for the first ...

  16. Vertigo/dizziness as a Drugs′ adverse reaction

    Directory of Open Access Journals (Sweden)

    Serafina Chimirri

    2013-01-01

    Full Text Available Introduction: Vertigo, dizziness, and nausea encompass a spectrum of balance-related symptoms caused by a variety of etiologies. Balance is affected by many systems: Proprioceptive pathways and visual, cerebellar, vestibulocochlear, and vascular / vasovagal systems. Vertigo is a subtype of dizziness, in which a subject, as a result to a dysfunction of the vestibular system, improperly experiments the perception of motion. The most useful clinical subdivision is to categorize vertigo into true vertigo and pseudovertigo, whereas from a pathophysiological point of view, vertigo can be classified into central, peripheral, and psychogenic. It is not easy to identify the cause of vertigo since the patients often are not able to precisely describe their symptoms. An impressive list of drugs may cause vertigo or dizziness. Materials and Methods: The aim of the present study was to analyze the data extracted from the reporting cards of the ADRs (adverse drug reactions, received at our Pharmacovigilance Regional Center (Calabria, Italy in 2012. In particular, the data concerning the occurrence of vertigo and dizziness, after taking certain classes of drugs, have been considered. Results: Our results show that, among the side-effects of different classes of drugs such as anti-convulsants, anti-hypertensives, antibiotics, anti-depressants, anti-psychotics, and anti-inflammatory, also vertigo or dizziness are included. Conclusions: Spontaneous reports of vertigo or dizziness, as side-effect of certain drugs, received at our Pharmacovigilance Center, represented the 5% of all reports in 2012. Considering the high incidence of such an ADR for several drugs′ classes, it can be speculated that under-reporting also affect vertigo and dizziness. Despite the fact that these ADRs might not represent a direct threaten for life, indirectly they can cause secondary damage to patients such as falls, fractures etc. Balance should be accurately monitored during drug use

  17. Reporting vaccine-associated adverse events.

    OpenAIRE

    Duclos, P.; Hockin, J; Pless, R; Lawlor, B.

    1997-01-01

    OBJECTIVE: To determine family physicians' awareness of the need to monitor and report vaccine-associated adverse events (VAAE) in Canada and to identify mechanisms that could facilitate reporting. DESIGN: Mailed survey. SETTING: Canadian family practices. PARTICIPANTS: Random sample of 747 family physicians. Overall response rate was 32% (226 of 717 eligible physicians). MAIN OUTCOME MEASURES: Access to education on VAAE; knowledge about VAAE monitoring systems, reporting criteria, and repor...

  18. 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.

  19. Safely Using TCM Herbs:Adverse Reaction and Precautions (Continued)

    Institute of Scientific and Technical Information of China (English)

    CHEN Kai(陈楷); Angela Berscheid

    2004-01-01

    @@ Chan su (Venenum Bufonis,蟾酥) Its main active and toxic constituent is bufotoxin, which has a function similar to digitalis glycosides. Adverse reactions and toxicity: Chan su, although it is used in patentpreparations, is traditionally known for its toxicity and is seldom used in decoctions. Toxicity is often due to over dosage of the patents, such as Liushenwan (六神丸) and Houzhengwan (喉症丸,). After administration one and a half to two hours, symptoms similar to digitalis toxicity appear, such as nausea, which is often the first indicator of toxicity, anorexia, vomiting, visual disturbances relating to colour vision, headache, weakness, psychosis, arrythmias, slowing of heart rate, AV block, and asystole.Severe cardiac damage is the major cause of death. It has al so been known to promote contraction of the uterus; therefore it should not be used in pregnant women(40,41). One paper has reported 27 cases intoxicated by Liushenwan, inclu ding one fatal(13).

  20. Safety profile and protocol prevention of adverse reactions to uroangiographic contrast media in diagnostic imaging.

    Science.gov (United States)

    Rossi, C; Reginelli, A; D'Amora, M; Di Grezia, G; Mandato, Y; D'Andrea, A; Brunese, L; Grassi, R; Rotondi, A

    2014-01-01

    The purpose of the study is to examine the incidence of adverse reactions caused by non-ionic contrast media in selected patients after desensitization treatment and to evaluate the safety profile of organ iodine contrast media (i.c.m.) in a multistep prevention protocol. In a population of 2000 patients that had received a CT scan, 100 patients with moderate/high risk for adverse reactions against iodinated contrast agents followed a premedication protocol and all adverse reactions are reported and classified as mild, moderate or severe. 1.7 percent of the pre-treated patients reported a mild, immediate type reaction to iodine contrast; of these five patients with allergy 0.71 percent had received iomeprol, 0.35 percent received ioversol and 0.71 percent received iopromide. The incidence of adverse reactions was reported to be higher (4 out of 5 patients) among those that referred a history of hypersensitivity against iodinated i.c.m. Although intravenous contrast materials have greatly improved, especially in terms of their safety profile, they should not be administered if there isn't a clear or justified indication. In conclusion, even if we know that the majority of these reactions are idiosyncratic and unpredictable we propose, with the aim of improving our knowledge on this subject, a multicenter study, based on skin allergy tests (prick test, patch test, intradermal reaction) in selected patients that have had previous experiences of hypersensitivity against parenteral organ iodine contrast media. PMID:24750802

  1. Antiepileptic Drug-Related Adverse Reactions and Factors Influencing These Reactions

    Directory of Open Access Journals (Sweden)

    Parvaneh KARIMZADEH

    2013-08-01

    ictal semiology: report of the ILAE task force on classification and terminology. Epilepsia 2001; 42: 1212Y1218. 2. Atlas:Epilepsy care in the world 2005.Available at: www.who.int/mental_health/neurology/epilepsy_atlas_introdion.pdf. Accessed October 9, 2010. 3. Noorbala AA, Bagheri Yazdi SA, Yasamy MT, et al. Mental health survey of the adult population in Iran. Br J Psychiatry 2004;184:70Y73. 4. Mohammadi MR, Ghanizadeh A, Davidian H, et al. Prevalence of epilepsy and comorbidity of psychiatric disorders in Iran. Seizure 2006;15:476Y482. 5. McAuley JW, Lott RS. Seizure disorders. In: Koda-Kimble MA, Young LY, Kradjan WA, et al, eds.Applied Therapeutics: The Clinical Use of Drugs. 9th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2008:54-1Y54-38. 6. Perucca E, Beghi E, Dulac O, et al. Assessing risk to benefit ratio in antiepileptic drug therapy. Epilepsy Res 2000; 41: 107Y139. 7. Mansur AT, Pekcan Yasar S, Goktay F. Anticonvulsant hypersensitivity syndrome. Clinical and laboratory features. Int J Dermatol 2008; 47: 1184-9. 8. Bahareh Malekafzali,Franak Najibi, Cutaneous reactions of anticonvulsant drugs, in Jdermatology 2012;47:1. 9. Brandon D. Newell, Maryam Moinfar,_ Anthony J. Mancini,_and Amy Jo Nopper. Retrospective Analysis of 32 Pediatric Patients with Anticonvulsant Hypersensitivity Syndrome   (ACHSS.2009; Pediatric Dermatology 26 : 5; 536–546. 10. Sharma VK, Sethuraman G, kumear B. Cotaneous adverse drug reactions: Clinical pattern and causative agents, A 6 years Series from chandigarh, India. Postgrad Med 2001; 47: 95-9. 11. Sushma M, Noel MV, Ripika MC, Jamef J,.Guido S. Cutaneous adverse drug reactions: A 9 Year Study from a sath Indian hospital. Safety 2005; 14(8: 567-70.

  2. Organizational liability for adverse reactions to the contrast media

    International Nuclear Information System (INIS)

    Contrast medium is a very useful tool for X-ray examinations. But contrast medium has some unavoidable adverse reactions. For those patients who have never received contrast medium before, it is impossible to predict whether they will suffer from certain kinds of adverse reactions. Thus, radiologists should use strategies to minimize adverse events and be prepared to promptly recognize and manage any reactions to the contrast media. If a radiologist commits medical malpractice, he will face civil responsibility. Medical malpractice means a tort or breach of contrast that occurs in a medical setting. Medical malpractices happen, despite the efforts of hospital staff. Many courts have applied the traditional doctrine of respondeat superior in actions against organizations for injuries caused by their employees. It is a legal doctrine, which states that an employer is responsible for employee actions performed within the course of the employment. A hospital is an organization for health purposes. An organization may be convicted of an offense committed by an employee of the organization acting in its behalf and within the scope of this office or employment. Organizational liability involves a wide variety of legal issues, including tort liability, wrongful employment practices, personal injury, breach of fiduciary duty, and so on. Many executive directors of organizations are aware of their personal and organizational risks of exposure to legal liabilities. The employer must have the right to control the physical conduct of the employee and must consent to receive the employee's services, while expecting some benefits from the services offered. Therefore, legal liability can be imposed for improper selection, assignment, training, and supervision of employees. In conclusion, the hospital itself has organizational liability for adverse reactions to the contrast medium

  3. Automagically encoding Adverse Drug Reactions in MedDRA

    OpenAIRE

    Combi, Carlo; Lora, Riccardo; Moretti, Ugo; Pagliarini, Marco; Zorzi, Margherita

    2015-01-01

    Pharmacovigilance is the field of science devoted to the collection, analysis and prevention of Adverse Drug Reactions (ADRs). Efficient strategies for the extraction of information about ADRs from free text resources are essential to support the work of experts, employed in the crucial task of detecting and classifying unexpected pathologies possibly related to drug assumptions. Narrative ADR descriptions may be collected in several way, e.g. by monitoring social networks or through the so c...

  4. Predicting risk of adverse drug reactions in older adults

    OpenAIRE

    Lavan, Amanda Hanora; Gallagher, Paul

    2016-01-01

    Adverse drug reactions (ADRs) are common in older adults, with falls, orthostatic hypotension, delirium, renal failure, gastrointestinal and intracranial bleeding being amongst the most common clinical manifestations. ADR risk increases with age-related changes in pharmacokinetics and pharmacodynamics, increasing burden of comorbidity, polypharmacy, inappropriate prescribing and suboptimal monitoring of drugs. ADRs are a preventable cause of harm to patients and an unnecessary waste of health...

  5. [Adverse drug reactions in multidrug-resistant tuberculosis].

    Science.gov (United States)

    Palmero, Domingo; Cruz, Víctor; Museli, Tomás; Pavlovsky, Hernán; Fernández, Juan; Waisman, Jaime

    2010-01-01

    Multidrug-resistant tuberculosis (MDRTB) poses difficulties in diagnosis and treatment, including increased frequency of adverse reactions to antituberculosis drugs (ADRAs), which compromise the effectiveness of treatment. This is specially complicated in the treatment of patients co-infected with HIV which includes the antiretroviral therapy plus the treatment of eventual comorbidities. A total of 121 MDRTB patients, 87 HIV-negative and 34 HIV positive, assisted in the Hospital F. J. Muñiz, Buenos Aires, during the period 2003-2007 were retrospectively studied. The incidence of ADRAs among the two groups of patients was compared. All the patients with adherence to treatment (no more than one abandon, recovered) were included in the study. Antituberculosis drugs used were: ethambutol, pyrazinamide, ofloxacin, moxifloxacin, cycloserine, ethionamide, PAS, streptomycin, kanamycin, amikacin and linezolid. The emergence of ADRAs and the proportion of severe reactions attributed to antituberculosis drugs were similar in both groups: 44.8% in HIV negative and 44.1% in HIV positive, but it was observed an additional 23.5% of adverse reactions to antiretroviral therapy in the second group. There were differences in the type of reactions and time of occurrence between the two groups. One HIV positive patient died of epidermolysis. The proportion of adverse reactions in HIV/AIDS patients increased 50% when those attributed to antiretroviral treatment were included. We conclude that the studied population showed a frequency of ADRAs higher than it would be expected in the treatment of susceptible TB, but there was no difference in its frequency among HIV-negative and positive patients. PMID:20920959

  6. Adverse reactions to iodinated contrast media administered at the time of endoscopic retrograde cholangiopancreatography (ERCP).

    Science.gov (United States)

    Pan, Jen-Jung; Draganov, Peter V

    2009-03-01

    Adverse reactions after intravascular administration of iodine contrast media are common and prophylactic regiments consisting of the use of steroids and low osmolality contrast media are highly effective in significantly decreasing the adverse reactions rate. The same type of contrast media are also used for opacification of the biliary tree and the pancreatic duct at the time of endoscopic retrograde cholangiopancreatography (ERCP). Systemic absorption of contrast media after ERCP routinely occurs. Although the adverse reaction rate appears to be very low the exact incidence remains unknown due to the retrospective nature of all reports. Despite the lack of formal recommendations, numerous prophylactic regiments are routinely used prior to ERCP in patients with history of prior reaction to intravascular contrast media. Moreover, the use of prophylaxis has even expanded to patients with no prior reaction to intravascular contrast media who are somehow perceived to be at increase risk (e.g. shellfish allergy). Recently, the first large scale prospective study reported exceedingly low incidence of adverse reaction to high oslmolality iodine-containing contrast media administered at the time of ERCP done without prophylactic premedication even in patients considered to be at the highest risk (prior severe reaction to intravascular contrast media administration). These data suggest that the use of prophylactic regiments prior to ERCP appears to be unnecessary. PMID:19275689

  7. Pharmacoepidemiological characterization of drug-induced adverse reaction clusters towards understanding of their mechanisms.

    Science.gov (United States)

    Mizutani, Sayaka; Noro, Yousuke; Kotera, Masaaki; Goto, Susumu

    2014-06-01

    A big challenge in pharmacology is the understanding of the underlying mechanisms that cause drug-induced adverse reactions (ADRs), which are in some cases similar to each other regardless of different drug indications, and are in other cases different regardless of same drug indications. The FDA Adverse Event Reporting System (FAERS) provides a valuable resource for pharmacoepidemiology, the study of the uses and the effects of drugs in large human population. However, FAERS is a spontaneous reporting system that inevitably contains noise that deviates the application of conventional clustering approaches. By performing a biclustering analysis on the FAERS data we identified 163 biclusters of drug-induced adverse reactions, counting for 691 ADRs and 240 drugs in total, where the number of ADR occurrences are consistently high across the associated drugs. Medically similar ADRs are derived from several distinct indications for use in the majority (145/163=88%) of the biclusters, which enabled us to interpret the underlying mechanisms that lead to similar ADRs. Furthermore, we compared the biclusters that contain same drugs but different ADRs, finding the cases where the populations of the patients were different in terms of age, sex, and body weight. We applied a biclustering approach to catalogue the relationship between drugs and adverse reactions from a large FAERS data set, and demonstrated a systematic way to uncover the cases different drug administrations resulted in similar adverse reactions, and the same drug can cause different reactions dependent on the patients' conditions. PMID:24534381

  8. [Adverse reactions to iodinated contrast media: how to prevent them?].

    Science.gov (United States)

    Berner, Jeanne; Poletti, Pierre-Alexandre; Becker, Christoph D; Nendaz, Mathieu

    2009-10-14

    The incidence of acute iodine contrast media reactions, appearing within the first hour after the procedure, is low but clinically important due to their daily use. Previous adverse reactions to iodinated contrast media, asthma and a history of allergic reaction are the most recognized risk factors, but the identification of patients at risk remains difficult. The efficacy of preventive measures such as corticosteroid and/or antihistaminic administration rests on low-level evidence. Practical recommendations are presented in this article. Rather than relying on the sole administration of a premedication, the importance of other measures must be stressed: assessing the relevance of the indication to the radiologic exam, use of low osmolarity contrast media, and ensuring a proper monitoring of the patient during and after the procedure. PMID:19911686

  9. Adverse blood transfusion reactions at tertiary care hospital

    Directory of Open Access Journals (Sweden)

    Surekha K. Chavan

    2016-06-01

    Conclusions: Not a single case of anaphylactic reactions, TRALI, acute immune hemolytic transfusion reaction, and Sepsis was observed. This can be an underestimation of the true incidence because of under reporting which can be improved by proper hemovigilence system to provide better patient care. [Int J Res Med Sci 2016; 4(6.000: 2402-2407

  10. Clinical Indications and Adverse Reactions of Platelet Apheresis

    International Nuclear Information System (INIS)

    Objective: To determine the clinical indications and adverse reactions of platelet apheresis procedure. Study Design: Cross-sectional, observational study. Place and Duration of Study: Blood Bank of Pakistan Atomic Energy Commission General Hospital, Islamabad, from January 2010 to December 2014. Methodology: 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. Results: Donor deferral rate in the study was 63.83 percentage. All the donors were males (100 percentage) and replacement donors. Most prevalent blood type was B-positive (n=63, 31.5 percentage), followed by O-positive (n=59, 29.5 percentage). Rh negative groups constituted 13.5 percentage (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/ micro L. The postprocedure average platelet count was approximately 200,000/ micro L. 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 percentage) final products were contaminated with red cells. Three (1.5 percentage) products were not issued and finally expired. Of the 125 patients for which plateletpheresis procedures were performed, 54 (43.2 percentage) patients were males and 71 (56.8 percentage) were females (M: F=0.76:1). Six donors (3 percentage) had adverse events: three donors (1.5 percentage) had mild reactions, two (1 percentage) moderate reaction, and one donor (0.5 percentage) developing

  11. 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

  12. Hyperglycemic adverse events following antipsychotic drug administration in spontaneous adverse event reports

    OpenAIRE

    Kato, Yamato; Umetsu, Ryogo; Abe, Junko; Ueda, Natsumi; NAKAYAMA, Yoko; Kinosada, Yasutomi; NAKAMURA, MITSUHIRO

    2015-01-01

    Background Antipsychotics are potent dopamine antagonists used to treat schizophrenia and bipolar disorder. The aim of this study was to evaluate the relationship between antipsychotic drugs and adverse hyperglycemic events using the FDA Adverse Event Reporting System (FAERS) database. In particular, we focused on adverse hyperglycemic events associated with atypical antipsychotic use, which are major concerns. Findings We analyzed reports of adverse hyperglycemic events associated with 26 an...

  13. Pharmaco-epidemiology of Sumatriptan : cardiovascular adverse reactions to a new antimigrainous drug

    NARCIS (Netherlands)

    J.P. Ottervanger (Jan Paul)

    1996-01-01

    textabstractThe rationale to study a potential adverse reaction of a specific drug mainly depends on three questions: 1) how serious is the adverse reaction? 2) what is the incidence of the adverse reaction among users of the dlUg?, and 3) what is the frequency of consumption of the specific dlUg in

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

    Directory of Open Access Journals (Sweden)

    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

  15. Adverse Reactions to Antituberculosis Drugs in Iranian Tuberculosis Patients

    Directory of Open Access Journals (Sweden)

    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.

  16. Immunologic basis for adverse reactions to radiographic contrast media

    International Nuclear Information System (INIS)

    The lymphocyte transformation test (LTT) was used to elucidate whether certain side effects induced by radiographic contrast media have an immunologic etiology. Groups studied were: 8 patients who had previously experienced adverse reactions in association with urography, 6 patients who underwent urography without notable side reactions, 17 occupationally exposed nurses, and 9 unexposed controls. The lymphocytes from 2 hypersensitive patients and from 11 nurses exhibited a positive proliferative response to amidotrizoate. Five nurses who had shown a positive response, had a previous history of hypersensitivity reactions when handling contrast media, whereas the remaining 6 were free of symptoms. Amidotrizoatespecific memory cells were absent in patients who underwent urography without signs of hypersensitivity and in 7/9 of unexposed control subjects. Lymphocytes from patients sensitive to amidotrizoate cross-reacted to structurally related ionic contrast media while nonionic contrast agents did not induce proliferation of the lymphocytes. Thus, ionic radiographic contrast agents have antigenic properties in man. Irradiated mixtures of radiographic contrast media and serum proteins were, in general, not effective in inducing an LTT response. (orig.)

  17. 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 reacti

  18. ARWAR: A network approach for predicting Adverse Drug Reactions.

    Science.gov (United States)

    Rahmani, Hossein; Weiss, Gerhard; Méndez-Lucio, Oscar; Bender, Andreas

    2016-01-01

    Predicting novel drug side-effects, or Adverse Drug Reactions (ADRs), plays an important role in the drug discovery process. Existing methods consider mainly the chemical and biological characteristics of each drug individually, thereby neglecting information hidden in the relationships among drugs. Complementary to the existing individual methods, in this paper, we propose a novel network approach for ADR prediction that is called Augmented Random-WAlk with Restarts (ARWAR). ARWAR, first, applies an existing method to build a network of highly related drugs. Then, it augments the original drug network by adding new nodes and new edges to the network and finally, it applies Random Walks with Restarts to predict novel ADRs. Empirical results show that the ARWAR method presented here outperforms the existing network approach by 20% with respect to average Fmeasure. Furthermore, ARWAR is capable of generating novel hypotheses about drugs with respect to novel and biologically meaningful ADR. PMID:26638149

  19. FDA Adverse Event Reporting System (FAERS): Latest Quartely Data Files

    Data.gov (United States)

    U.S. Department of Health & Human Services — The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database...

  20. CDC WONDER: Vaccine Adverse Event Reporting System (VAERS)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Vaccine Adverse Event Reporting System (VAERS) online database on CDC WONDER provides counts and percentages of adverse event case reports after vaccination, by...

  1. Adverse events due to the immunization: Case report

    Directory of Open Access Journals (Sweden)

    Medić Snežana

    2012-01-01

    Full Text Available Introduction. An adverse event after immunization is a medical incident following the administration of vaccine, which can be connected with vaccine usage. This event could be a reaction to a vaccine component or lapse in vaccine handling, transport and storage or coincidental event. The assessment of severity of this reaction and the decision about prospective permanent contraindications for futher immunization are to be made by the regional expert team for permanent contraindications. This is regulated by low. Case report. A series of adverse events after immunization in three children of a single family is reported. As regulated by law, all three children were vaccinated with different vaccines, from 2007. to 2010. Although the recorded events were diverse by their nature, way of clinical manifestation and severity they all required hospitalization. In addition to being siblings, the three children had the same atopic diseases in their personal and family anamnesis. All adverse events were explored including allergological/immunological tests. Thanks to the good cooperation of involved general practicioners, pediatricians, members of expert team for permanent contraindications and clinicians, two of three children received the full series of vaccines in optimal time. Discussion. Decision making about futher immunization of children with adverse event after vaccine administration depends on the nature and severity of developed medical condition, results of medical exploration, existing immunity and personal risk of getting disease and subsequent complications. Conclusion. Bearing in mind the significance of immunization for personal and collective immunity, good cooperation of all physicians and experts involved in each single case of adverse event is required.

  2. 21 CFR 600.80 - Postmarketing reporting of adverse experiences.

    Science.gov (United States)

    2010-04-01

    ... Evaluation and Research (see mailing addresses in § 600.2). Submit all vaccine adverse experience reports to: Vaccine Adverse Event Reporting System (VAERS) (see mailing addresses in § 600.2). FDA may waive the... history of actions taken since the last report because of adverse experiences (for example,...

  3. Toxic epidermal necrolysis: a severe cutaneous adverse drug reaction

    Directory of Open Access Journals (Sweden)

    K. N. Chidananda

    2015-02-01

    Full Text Available Toxic epidermal necrolysis (TEN is a rare but serious is a rare but potentially life-threatening condition. It is primarily a cutaneous reaction to various precipitating agents, characterized by wide spread erythema and detachment of the epidermis from the dermis. Among the various cutaneous adverse drug reactions, TEN occupy a primary place in terms of mortality. In TEN large sheets of skin are lost from the body surface, thereby decreasing the protecting function of the skin, which results in complications. Usually, TEN is self-limited in absence of complications. If complicated by sepsis, there will be increased chances of mortality. The main treatment would be cessation of the causative drug and early admission of the patient for supportive care and minimizing the occurrence of complications. The present articles reviews the etiology, pathophysiology, differential diagnosis and treatment protocol, with a case of TEN occurrence in a child of 4 years age after consuming phenytoin syrup for febrile convulsions. [Int J Basic Clin Pharmacol 2015; 4(1.000: 1-5

  4. [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. PMID:27177895

  5. Adverse reactions to cosmetics and methods of testing

    Directory of Open Access Journals (Sweden)

    Nigam P

    2009-01-01

    Full Text Available Untoward reactions to cosmetics, toiletries, and topical applications are the commonest single reason for hospital referrals with allergic contact dermatitis. In most cases, these are only mild or transient and most reactions being irritant rather than allergic in nature. Various adverse effects may occur in the form of acute toxicity, percutaneous absorption, skin irritation, eye irritation, skin sensitization and photosensitization, subchronic toxicity, mutagenicity/genotoxicity, and phototoxicity/photoirritation. The safety assessment of a cosmetic product clearly depends upon how it is used, since it determines the amount of substance which may be ingested, inhaled, or absorbed through the skin or mucous membranes. Concentration of ingredients used in the different products is also important. Various test procedures include in vivo animal models and in vitro models, such as open or closed patch test, in vivo skin irritation test, skin corrosivity potential tests (rat skin transcutaneous electrical resistance test, Episkin test, eye irritation tests (in vivo eye irritancy test and Draize eye irritancy test, mutagenicity/genotoxicity tests (in vitro bacterial reverse mutation test and in vitro mammalian cell chromosome aberration test, and phototoxicity/photoirritation test (3T3 neutral red uptake phototoxicity test. Finished cosmetic products are usually tested in small populations to confirm the skin and mucous membrane compatibility, and to assess their cosmetic acceptability.

  6. Analysis of the Reports of Adverse Drug Reactions Induced by PEG-interferon Alfa-2a Injection%聚乙二醇干扰素α-2a注射液不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    韩丹; 代菲; 储文功

    2013-01-01

    目的:探讨聚乙二醇干扰素α-2a注射液不良反应发生的特点及相关因素,为临床安全用药提供参考.方法:收集某省药品不良反应监测中心2004~2011年自发呈报系统上报的1 606例聚乙二醇干扰素α-2a注射液的不良反应(ADR)报告,对ADR所涉及的患者年龄、性别,以及ADR年份、类型、结果、临床表现等进行统计分析.结果:1606例报告中,男883例,女723例,30 ~60岁患者最多(72.6%);发生严重不良反应243例,新的严重ADR 86例;临床表现以血液系统损害为主占59.95%,其次为肝胆系统损害占10.76%.结论:临床在运用聚乙二醇干扰素α-2a治疗丙肝的过程中,应密切观察其ADR,制定周密的护理计划,积极干预和防治,以有效减少和防止ADR发生.%To probe into the characteristics of adverse drug reactions (ADR) caused by PEG-interferon alfa-2a injection to provide some rational clinical guidance. Methods: 1606 reports of adverse reactions caused by PEG-interferon alfa-2a injection were collected from January 2004 to December 2011 and statistically analyzed in respect of patients'sex and age, involved type, years, result, clinical manifestations, etc. Results:883 of the 1606 cases were male cases,723 were female cases, and 72. 6% were the adults at the age of 30 to 60.The incidence rate of severe ADR were 243 cases, and new and severe ADR were 86 cases. The blood system was the main lesion in ADR cases (59.95%) , and the second was liver and gall system(10.76%). Conclusion: The corresponding adverse reactions should be closely observed during the clinical use of PEG-interferon alfa-2a in the treatment of hepatitis C. The occurrence of adverse reactions could be effectively reduced and prevented by making a careful nursing plan and conducting an active intervention and control.

  7. Progressive multifocal leukoencephalopathy associated with brentuximab vedotin therapy: A report of 5 cases from the Southern Network on Adverse Reactions (SONAR) project

    Science.gov (United States)

    Carson, Kenneth R.; Newsome, Scott D.; Kim, Ellen J.; Wagner-Johnston, Nina D.; von Geldern, Gloria; Moskowitz, Craig H.; Moskowitz, Alison J.; Rook, Alain H.; Jalan, Pankaj; Loren, Alison W.; Landsburg, Daniel; Coyne, Thomas; Tsai, Donald; Raisch, Dennis W.; Norris, LeAnn B.; Bookstaver, P Brandon; Sartor, Oliver; Bennett, Charles L.

    2015-01-01

    Purpose Brentuxiumab vedotin (BV) is an anti-CD30 monoclonal antibody-drug conjugate approved in 2011 for treating anaplastic large cell and Hodgkin lymphomas. The product label indicates that three BV-treated patients developed progressive multifocal leukoencephalopathy (PML), a frequently fatal JC-virus induced central nervous system infection. Prior immunosuppressive therapy and compromised immune systems were postulated risk factors. We report 5 patients who developed BV-associated PML, including two immunocompetent patients. Patients Case information was obtained from clinicians (four patients) or a Food and Drug Administration database (one patient). Results All five patients had lymphoid malignancies. Two patients with cutaneous T-cell lymphomas had not previously received chemotherapy. PML developed after a median of three BV doses (range, 2 to 6) and within a median of 7 weeks following BV initiation (range, 3 to 34 weeks). Presenting findings included aphasia, dysarthria, confusion, hemiparesis, and gait dysfunction; JC virus in cerebrospinal fluid (two patients), or CNS biopsy (three patients); and brain MRI scans with white matter abnormalities (five patients). Four patients died a median of 8 weeks (range, 6 to 16 weeks) after PML diagnosis. The sole survivor developed immune reconstitution inflammatory syndrome. Conclusion PML can develop after a few BV doses and within weeks of BV initiation. Clinicians should be aware of this syndrome, particularly when neurologic changes develop following BV initiation. The decision to administer BV to patients with indolent cutaneous lymphomas should be based on consideration of risk-benefit profiles and of alternative options. PMID:24771533

  8. The role of the Australian Adverse Drug Reactions Advisory Committee (ADRAC) in monitoring drug safety

    International Nuclear Information System (INIS)

    The Australian adverse drug reaction reporting system is acknowledged as one of the best in the world. Despite its small population of less than 20 million people, Australia's current ADR reporting rate of over 12000 reports per year places it in the top few nations in terms of reports per capita. The ADRAC program has been in operation for over 30 years. Australia was a founding member of the WHO International Drug Monitoring Programme which commenced in 1968 and currently there are about 153000 reports in the ADRAC database. Reports from health professionals have uncovered a number of significant safety problems over the years. Of particular importance are flucloxacillin-induced hepatitis, amoxycillin/clavulanate-induced hepatitis, and the association of cystitis with tiaprofenic acid. The number and quality of the reports has allowed an understanding of the characteristics of the reactions and, using ADRAC reporters as a major source of cases, case-control studies have been completed which have identified risk factors. ADRAC's review of Australian reports has highlighted many important associations that have been disseminated through the Australian Adverse Drug Reactions Bulletin

  9. 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.

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

    International Nuclear Information System (INIS)

    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. 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.)

  12. EDITORIAL ADVERSE DRUG REACTIONS: A MULTIFORM PATHOLOGY RESPONSABILITY OF MANY

    Directory of Open Access Journals (Sweden)

    Joan-Ramon Laporte

    2009-09-01

    Full Text Available Possibly still are health professionals that when hearing about adverse drug reactions only think in cutaneous rash, blood dyscrasias, anaphylactic shock and congenital malformations. The mentioned adverse effects are real, but relatively infrequent. Furthermore, are unexpected, not related with the pharmacological mechanism of action, unpredictable and dose independent. These adverse drug reactions are like a therapeutic lottery, depending on «luck».However, when the pharmacological pathology resulting in medical care is analyzed, the perspective is very different. For instance, the predominant adverse drug reactions in emergency wards are those related with the pharmacological mechanism of action: severe hemorrhage due to anticoagulant and antiplatelet drugs; renal insufficiency and hyperkalemia by inhibitors of the renin-angiotensin axis; hyponatremia, fells and fractures by SSRI antidepressants, digitalis intoxication… These are relatively common pathologies, expectable, dose-related, and favored by patient comorbidity, preventable in many cases if the dose would have carefully individualized, if the patient complied better with the instructions (in case the patient understood the information or if a more carefully clinical surveillance were performed.A review of the literature reminds us other pathologies attended in other assistance levels, for example:- Breast cancer attributable to the hormone replacement therapy (HRT: three to four additional cases per 1.000 women treated during 5 years, this is translated in thousands of additional cases of breast cancer according to the sales data of these products between the years 1993 to 2003. Moreover, it was irresponsibly promoted for the prevention of cardiovascular events, dementia, and as the source of eternal youth without proven efficacy at that time (no evidence of efficacy exist today.- Non-steroidal anti-inflammatory drugs (NSAIDs - especially celecoxib and diclofenac -increase the

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

    OpenAIRE

    Hye Ran Na; Jeong Min Lee; Jo Won Jung; Soo-Young Lee

    2011-01-01

    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 ...

  14. Frequency and Pattern of Noninfectious Adverse Transfusion Reactions at a Tertiary Care Hospital in Korea

    OpenAIRE

    Cho, Jooyoung; Choi, Seung Jun; Kim, Sinyoung; Alghamdi, Essam; Kim, Hyun Ok

    2015-01-01

    Background Although transfusion is a paramount life-saving therapy, there are multiple potential significant risks. Therefore, all adverse transfusion reaction (ATR) episodes require close monitoring. Using the computerized reporting system, we assessed the frequency and pattern of non-infectious ATRs. Methods We analyzed two-year transfusion data from electronic medical records retrospectively. From March 2013 to February 2015, 364,569 units of blood were transfused. Of them, 334,582 (91.8%)...

  15. Consideration of Adverse Reaction to MDCT Contrast Media

    International Nuclear Information System (INIS)

    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.

  16. 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.

  17. Predicting risk of adverse drug reactions in older adults.

    Science.gov (United States)

    Lavan, Amanda Hanora; Gallagher, Paul

    2016-02-01

    Adverse drug reactions (ADRs) are common in older adults, with falls, orthostatic hypotension, delirium, renal failure, gastrointestinal and intracranial bleeding being amongst the most common clinical manifestations. ADR risk increases with age-related changes in pharmacokinetics and pharmacodynamics, increasing burden of comorbidity, polypharmacy, inappropriate prescribing and suboptimal monitoring of drugs. ADRs are a preventable cause of harm to patients and an unnecessary waste of healthcare resources. Several ADR risk tools exist but none has sufficient predictive value for clinical practice. Good clinical practice for detecting and predicting ADRs in vulnerable patients includes detailed documentation and regular review of prescribed and over-the-counter medications through standardized medication reconciliation. New medications should be prescribed cautiously with clear therapeutic goals and recognition of the impact a drug can have on multiple organ systems. Prescribers should regularly review medication efficacy and be vigilant for ADRs and their contributory risk factors. Deprescribing should occur at an individual level when drugs are no longer efficacious or beneficial or when safer alternatives exist. Inappropriate prescribing and unnecessary polypharmacy should be minimized. Comprehensive geriatric assessment and the use of explicit prescribing criteria can be useful in this regard. PMID:26834959

  18. Physician access to drug profiles to reduce adverse reactions

    Science.gov (United States)

    Yasnoff, William A.; Tomkins, Edward L.; Dunn, Louise M.

    1995-10-01

    Adverse drug reactions (ADRs) are a major source of preventable morbidity and mortality, especially among the elderly, who use more drugs and are more sensitive to them. The insurance industry has recently addressed this problem through the implementation of drug interaction alerts to pharmacists in conjunction with immediate online claims adjudication for almost 60% of prescriptions (expected to reach 90% within 5 years). These alerts are based on stored patient drug profiles maintained by pharmacy benefit managers (PBMs) which are updated whenever prescriptions are filled. While these alerts are very helpful, the pharmacist does not prescribe, resulting in time-consuming and costly delays to contact the physician and remedy potential interactions. We have developed and demonstrated the feasibility of the PINPOINT (Pharmaceutical Information Network for prevention of interactions) system for making the drug profile and interaction information easily available to the physician before the prescription is written. We plan to test the cost-effectiveness of the system in a prospective controlled clinical trial.

  19. Adverse allergic reactions to linear ionic gadolinium-based contrast agents: experience with 194, 400 injections

    International Nuclear Information System (INIS)

    Aim: To report the authors' experience with the administration of four gadolinium-based contrast agents (GBCA; gadopentetate dimeglumine, gadofosveset trisodium, gadoxetate disodium and gadobenate dimeglumine) in a large study population at a single, large academic medical centre. Materials and methods: The institutional review board approved this retrospective study in which data in the electronic incident reporting system were searched. A total of 194, 400 intravenous administrations of linear ionic GBCAs were assessed for the incidence of adverse reactions and risk factors from 1 January 2007 to 14 January 2014. The severity of reactions (mild, moderate, and severe), patient type (outpatients, inpatients, and emergency), examination type, and treatment options were also investigated. Results: In total, 204/194400 (0.1%) patients (mean age 45.7 ± 14.9) showed adverse reactions, consisting of 6/746 (0.80%), 10/3200 (0.31%), 14/6236 (0.22%) and 174/184218 (0.09%), for gadofosveset trisodium, gadoxetate disodium, gadobenate dimeglumine, and gadopentetate dimeglumine, respectively. An overall significant difference was found between different GBCAs regarding the total number of reactions (p < 0.0001). When comparing the GBCAs together, significant differences were found between gadofosveset trisodium versus gadopentetate dimeglumine (p < 0.0001), gadofosveset trisodium versus gadobenate dimeglumine (p = 0.0051), gadoxetate disodium versus gadopentetate dimeglumine (p < 0.0001) and gadopentetate dimeglumine versus gadobenate dimeglumine (p = 0.0013). Rate of reaction was higher in females (F: 146/113187, 0.13%/M: 58/81213, 0.07%; p < 0.0001). Rate of reactions was higher in outpatient (180/158885, 0.11%), emergency (10/10413, 0.10%), and inpatients (14/25102, 0.05%), respectively (p < 0.0001). Most of the patients had mild symptoms 171/204 (83.8%). Abdomen–pelvis, liver, and thoracic examinations had highest rates of reactions (0.17 versus 0

  20. The severe adverse reaction to vitamin k1 injection is anaphylactoid reaction but not anaphylaxis.

    Science.gov (United States)

    Mi, Yan-Ni; Ping, Na-Na; Xiao, Xue; Zhu, Yan-Bing; Liu, Jing; Cao, Yong-Xiao

    2014-01-01

    The severe adverse reaction to vitamin K1 injection is always remarkable and is thought to result from anaphylaxis. Paradoxically, however, some patients administered vitamin K1 injection for the first time have adverse reactions. Using beagle dogs, the present study tested the hypothesis that the response to vitamin K1 is an anaphylactoid reaction. The results showed that serious anaphylaxis-like symptoms appeared in beagle dogs after the administration of vitamin K1 injection for the first time. The plasma histamine concentration increased, and blood pressure decreased sharply. After sensitization, dogs were challenged with vitamin K1 injection and displayed the same degree of symptoms as prior to sensitization. However, when the vitamin K1 injection-sensitized dogs were challenged with a vitamin K1-fat emulsion without solubilizers such asTween-80, the abnormal reactions did not occur. Furthermore, there was no significant change in the plasma immunoglobulin E concentration after vitamin K1 challenge. Following treatment with vitamin K1 injection, the release of histamine and β-hexosaminidase by rat basophilic leukemia-2H3 cells as well as the rate of apoptosis increased. The Tween-80 group displayed results similar to those observed following vitamin K1 injection in vivo. However, the dogs in the vitamin K1-fat emulsion group did not display any abnormal behavior or significant change in plasma histamine. Additionally, degranulation and apoptosis did not occur in rat basophilic leukemia-2H3 cells. Our results indicate that the adverse reaction induced by vitamin K1 injection is an anaphylactoid reaction, not anaphylaxis. Vitamin K1 injection induces the release of inflammatory factors via a non-IgE-mediated immune pathway, for which the trigger may be the solubilizer. PMID:24594861

  1. The severe adverse reaction to vitamin k1 injection is anaphylactoid reaction but not anaphylaxis.

    Directory of Open Access Journals (Sweden)

    Yan-Ni Mi

    Full Text Available The severe adverse reaction to vitamin K1 injection is always remarkable and is thought to result from anaphylaxis. Paradoxically, however, some patients administered vitamin K1 injection for the first time have adverse reactions. Using beagle dogs, the present study tested the hypothesis that the response to vitamin K1 is an anaphylactoid reaction. The results showed that serious anaphylaxis-like symptoms appeared in beagle dogs after the administration of vitamin K1 injection for the first time. The plasma histamine concentration increased, and blood pressure decreased sharply. After sensitization, dogs were challenged with vitamin K1 injection and displayed the same degree of symptoms as prior to sensitization. However, when the vitamin K1 injection-sensitized dogs were challenged with a vitamin K1-fat emulsion without solubilizers such asTween-80, the abnormal reactions did not occur. Furthermore, there was no significant change in the plasma immunoglobulin E concentration after vitamin K1 challenge. Following treatment with vitamin K1 injection, the release of histamine and β-hexosaminidase by rat basophilic leukemia-2H3 cells as well as the rate of apoptosis increased. The Tween-80 group displayed results similar to those observed following vitamin K1 injection in vivo. However, the dogs in the vitamin K1-fat emulsion group did not display any abnormal behavior or significant change in plasma histamine. Additionally, degranulation and apoptosis did not occur in rat basophilic leukemia-2H3 cells. Our results indicate that the adverse reaction induced by vitamin K1 injection is an anaphylactoid reaction, not anaphylaxis. Vitamin K1 injection induces the release of inflammatory factors via a non-IgE-mediated immune pathway, for which the trigger may be the solubilizer.

  2. Adverse Events in the Netherlands Vaccination Programme : Reports in 2010 and Review 1994-2010

    NARCIS (Netherlands)

    Vermeer-de Bondt PE; Moorer-Lanser N; PHaff TAJ; Oostvogels B; Wesselo C; van der Maas NAT; LCI; cib

    2012-01-01

    In 2010, 800,000 children received one or more vaccines on 1.3 million dates, with more than 7 million vaccine components. There is always some chance of adverse reactions but these are usually not severe, though sometimes frightening. This year, RIVM received 1380 reports of adverse events followin

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

    OpenAIRE

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

    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...

  4. Analysis of 109 Reports of Adverse Drug Reaction of Cefoperazone Sodium and Sulbactam Sodium for Injection%109例头孢哌酮钠舒巴坦钠不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    刘宪军; 付娜

    2014-01-01

    Objective To investigate relevant factors of the adverse drug reaction induced by cefoperazone sodium and sulbactam sodium for injection to provide scientific reference for the safe and rational drug use in clinic. Methods 109 ADR reports of cefoperazone sodium and sulbactam sodium for injection collected by Beijing Center for ADR Monitoring from January 2010 to October 2010 were statistically analyzed retrospectively. Results The clinical manifestations of ADR involved skins and appendages damage, blood system damage, digestive system damage, hepatobiliary system damage and generalized lesion. Most ADR cases occurred in 30 minutes after medication, and drug combination maybe cause serious adverse reactions. Conclusion The ADR induced by cefoperazone sodium and sulbactam sodium for injection is associated with its chemical structure, individual diathesis, different diet, drug combination and so on. In order to avoid the occurrence of ADR induced by cefoporazone sodium and sulbactam sodium for injection, the drug must be used rationally and the patient should be intensively warded.%目的:探讨头孢哌酮钠舒巴坦钠致不良反应发生的相关因素,为临床安全合理用药提供参考。方法采用回顾性研究方法,对2012年1月~2012年10月北京市药品不良反应监测中心收集的109例注射用头孢哌酮钠舒巴坦钠不良反应报告进行统计分析。结果头孢哌酮钠舒巴坦钠致不良反应累及系统-器官主要为皮肤及其附件、血液系统、胃肠系统、肝胆系统及全身性损害。多数不良反应出现在用药后30 min 内,且以联合用药出现不良反应的症状较重。结论头孢哌酮钠舒巴坦钠致不良反应与其化学结构、患者个体体质、饮食、联合用药等有关。加强注射用头孢哌酮钠舒巴坦钠的合理使用及用药监护,可以避免或减少不良反应的发生。

  5. Optimal management of acute nonrenal adverse reactions to iodine-based contrast media

    Directory of Open Access Journals (Sweden)

    Nielsen YW

    2013-06-01

    Full Text Available Yousef W Nielsen, Henrik S Thomsen Department of Radiology, Copenhagen University Hospital Herlev, Copenhagen, Denmark Abstract: Acute adverse reactions to iodine-based contrast media occur within 60 minutes of administration. The reactions range from mild (flushing, arm pain, nausea/vomiting, headache to moderate (bronchospasm, hypotension, and severe (cardiovascular collapse, laryngeal edema, convulsions, arrhythmias. Most acute adverse reactions occur in an unpredictable manner. Use of the older group of ionic iodine-based contrast agents increases the risk of acute adverse reactions. Other risk factors include previous reactions to contrast media, asthma, and allergic conditions. The exact pathophysiology of the acute adverse reactions is unknown, but some of the reactions are pseudoallergic mimicking type 1 allergic reactions. As antibodies against contrast media have not been consistently demonstrated, the reactions are, in most cases, not truly allergic in nature. Most of the severe and fatal adverse reactions occur within the first 20 minutes after injection. Thus, it is important that patients are observed in the radiology department during this period. The radiologist should be near the room where contrast media is administered, and be ready to treat any acute nonrenal adverse reaction. Appropriate drugs and resuscitation equipment should be in/near the room where the contrast media is administered. The important first-line management of acute adverse reactions includes the establishment of an adequate airway, oxygen supplementation by mask, intravenous fluid administration, and measurement of blood pressure and heart rate. When severe anaphylactoid reactions occur, adrenaline should be given intramuscularly. Only one concentration of adrenaline (1:1000–1 mg/mL should be available in the radiology department to avoid dosing errors in stressful acute settings. Resuscitation team specialists should be the only ones giving intravenous

  6. Adverse Reactions to Field Vaccination Against Lumpy Skin Disease in Jordan.

    Science.gov (United States)

    Abutarbush, S M; Hananeh, W M; Ramadan, W; Al Sheyab, O M; Alnajjar, A R; Al Zoubi, I G; Knowles, N J; Bachanek-Bankowska, K; Tuppurainen, E S M

    2016-04-01

    Lumpy skin disease (LSD) is an emerging disease in the Middle East region and has been recently reported in Jordan. The aim of this study was to investigate the adverse reactions that were reported after vaccine administration. Geographical areas enrolled in the study were free of the disease and away from the outbreak governorate. Sixty-three dairy cattle farms, with a total of 19,539 animals, were included in the study. Of those, 56 farms reported adverse clinical signs after vaccine administration. The duration between vaccine administration and appearance of adverse clinical signs ranged from 1 to 20 days (Mean = 10.3, SD ± 3.9). Clinical signs were similar to those observed with natural cases of lumpy skin disease. These were mainly fever, decreased feed intake, decreased milk production and variable sized cutaneous nodules (a few millimetres to around 2 cm in diameter) that could be seen anywhere on the body (head, neck, trunk, perineum), udder, and/or teats. Nodules were raised and firm initially and then formed dry scabs that could be peeled off the skin. The characteristic deep 'sit fast' appearance was rarely seen and most lesions were superficial. Some cattle had swollen lymph nodes, while a few pregnant animals aborted. The percentage of affected cattle ranged from 0.3 to 25% (Mean = 8, SD ± 5.1). Fever, decreased feed intake, and decreased milk production were seen in 83.9, 85.7, and 94.6% in cattle on the affected farms, respectively. All affected cattle displayed skin nodules over their entire bodies, while 33.9 and 7.1% of the affected farms reported nodular lesions present on the udders and teats, respectively. No mortalities were reported due to vaccine adverse reactions. Duration (course) of clinical signs ranged from 3 to 20 days (Mean = 13.7, SD ± 4.1). Two types of LSD vaccines were used by the farmers in this study. The first one was a sheep pox virus (SPPV) vaccine derived from the RM65 isolate [Jovivac, manufactured by Jordan

  7. Adverse Reaction to Cetuximab, an Epidermal Growth Factor Receptor Inhibitor.

    Science.gov (United States)

    Štulhofer Buzina, Daška; Martinac, Ivana; Ledić Drvar, Daniela; Čeović, Romana; Bilić, Ivan; Marinović, Branka

    2016-04-01

    Dear Editor, Inhibition of the epidermal growth factor receptor (EGFR) is a new strategy in treatment of a variety of solid tumors, such as colorectal carcinoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck, and pancreatic cancer (1). Cetuximab is a chimeric human-murine monoclonal antibody against EGFR. Cutaneous side effects are the most common adverse reactions occurring during epidermal growth factor receptor inhibitors (EGFRI) therapy. Papulopustular rash (acne like rash) develop with 80-86% patients receiving cetuximab, while xerosis, eczema, fissures, teleangiectasiae, hyperpigmentations, and nail and hair changes occur less frequently (2). The mechanism underlying these skin changes has not been established and understood. It seems EGFRI alter cell growth and differentiation, leading to impaired stratum corneum and cell apoptosis (3-5). An abdominoperineal resection of the rectal adenocarcinoma (Dukes C) was performed on a 43-year-old female patient. Following surgery, adjuvant chemo-radiotherapy was applied. After two years, the patient suffered a metastatic relapse. Abdominal lymphadenopathy was detected on multi-slice computer tomography (MSCT) images, with an increased value of the carcinoembryonic antigen (CEA) tumor marker (maximal value 57 ng/mL). Hematological and biochemical tests were within normal limits, so first-line chemotherapy with oxaliplatin and a 5-fluorouracil (FOLFOX4) protocol was introduced. A wild type of the KRAS gene was confirmed in tumor tissue (diagnostic prerequisite for the introduction of EGFRI) and cetuximab (250 mg per m2 of body surface) was added to the treatment protocol. The patient responded well to the treatment with confirmed partial regression of the tumor formations. Three months after the patient started using cetuximab, an anti-EGFR monoclonal antibody, the patient presented with a papulopustular eruption in the seborrhoeic areas (Figure 1) and eczematoid reactions on the extremities

  8. Sex-related differences in hospital admissions attributed to adverse drug reactions in the Netherlands

    NARCIS (Netherlands)

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

    2011-01-01

    textabstractAIM Adverse drug reactions (ADRs) are a major burden in health care, regularly leading to hospital admission, morbidity or death. Women tend to have a higher risk of adverse drug reactions with a 1.5 to 1.7-fold greater risk than men. Our primary aim was to study differences in ADR-relat

  9. Adverse Reaction Following Intravenous Immunoglobulin in Primary Immunodeficiency Patients

    Directory of Open Access Journals (Sweden)

    J. Ghaffari, M.D.+

    2007-01-01

    Full Text Available AbstractBackground and Purpose: Intravenous immunoglobulin is used for primary immunodeficiency disorders. There have been some reports that intravenous immunoglobulin causes side effects. The aim of this study was to investigate intravenous immunoglobulin side effects in immunodeficiency patients.Materials and Methods: The study utilized the data of 29 primary immunodeficiency patients that were referred to allergy and immunology department in Medical Children Center in Tehran. 29 patients having completed record data files in the hospital, were the subjects of this study.Results: Of 29 immune deficiency patients (aged 15 months to 55 years, they were 19 Males (65/51% and 10(34/48% Females. Prevalence of disorders include common variable immunodeficiency 16(55/17%, Bruton disease 8(27/58%, hyper IgM 4 (13/79% and severe combind immunodeficiency 1 (3/44%. Based on the recorded data, the duration of infusion has been 5 months to 15 years. 15 patients had reported side effects (51/72%. 34 infusions from the total of 1,626 infusions accompanied with side effects (2/09%. Most side effects were occurred during 30 minutes onset of infusion and most were caused by rapid infusion. Most side effects were mild reactions (fever, chills and ….Conclusion: Intravenous immunoglobulin is a rather safe drug with mild side effects. With an appropriate technique and proper infusion, these side effects can be reduced.

  10. Adverse drug reactions to fluoroquinolones at a tertiary care hospital in northern India.

    Science.gov (United States)

    Uppal, R; Jhaj, R; Malhotra, S

    1998-11-01

    Use of fluoroquinolones has increased considerably in the last 5-6 years in our hospitals. With a view to ascertain their safety and the type of adverse drug reactions (ADRs) in our population, spontaneous reports were collected and analysed to ciprofloxacin (the most prescribed fluoroquinolone in our hospital) over a period of three and a half years. The pattern of reactions were rash in 18, severe reactions like Steven Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) in 4, gastritis and diarrhoea in 3, shivering and rigors in 2, hemorrhagic purpuric spots in 2 and oedema of eye and lids with topical application in 1 patient. Most cases recovered on stoppage of the drug and symptomatic treatment. However, one case of SJS and one of TEN proved fatal. Care needs to be exercised in their use and they do not appear to be innocuous to severe and disturbing ADRs. PMID:11229222

  11. Adverse reactions following two separate intravascular injections of contrast media in the same patient

    International Nuclear Information System (INIS)

    Adverse reactions following contrast medium injections in 26 non-comparative and parallel trials were extracted from the iohexol vascular clinical trial program in Northern Europe. Six hundred and forty-one patients (13-88 years old) in whom information was available about a vascular contrast medium examination before the iohexol clinical trials were included, enabling a retrospective within patient comparison of adverse reactions. Iohexol gave a low recurrence frequency (approximately 3.5 times) of reactions than ionic monomers in patients who previously experienced adverse reactions to vascular contrast media. In order to overcome some of the drawbacks with the present retrospective design, prospective comparative studies are recommended. (orig.)

  12. 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.

  13. Retrospective evaluation of adverse transfusion reactions following blood product transfusion from a tertiary care hospital: A preliminary step towards hemovigilance

    OpenAIRE

    Praveen Kumar; Rakesh Thapliyal; Poonam Coshic; Kabita Chatterjee

    2013-01-01

    Background: The goal of hemovigilance is to increase the safety and quality of blood transfusion. Identification of the adverse reactions will help in taking appropriate steps to reduce their incidence and make blood transfusion process as safe as possible. Aims : To determine the frequency and type of transfusion reactions (TRs) occurring in patients, reported to the blood bank at our institute. Materials and Methods : A retrospective review of all TRs reported to the blood bank at the All I...

  14. Adverse drug reactions in internal medicine units at a university hospital: A descriptive pilot study

    Directory of Open Access Journals (Sweden)

    Luis Carlos López

    2010-09-01

    Full Text Available Introduction: Adverse drug reactions (ADRs are an important cause of morbidity and mortality among hospitalized patients. Objectives: This study was designed to describe the frequency, severity, and causality of ADRs in internal medicine units at a third-level university hospital. Materials and methods: A descriptive study was performed at internal medicine units, by means of a structured format, review of clinical records, and interview of hospitalized patients. The Naranjo algorithm was applied to patient adverse events to define causality. Additionally, ADRs were classified according to the Rawlins and Thompson criteria. Results: One hundred patients (50 men and 50 women were included in the study. Ninety nine (99 adverse events were found among the patients. The Naranjo algorithm was applied to adverse events, resulting in twenty nine (29 probable ADRs, twenty (20 possible ADRs and fifty (50 doubtful ADRs. Cardiovascular drugs and antibiotics were the most frequent therapeutic groups associated with ADRs. In addition, two preventable medication errors were identified. Conclusions: Frequency of ADRs was similar to the number reported in other studies in internal medicine units. It is necessary to systematize efforts of pharmacological surveillance in hospital wards, toward an opportune detection and prevention of ADRs.

  15. Adverse drug reactions in internal medicine units at a university hospital: A descriptive pilot study

    Directory of Open Access Journals (Sweden)

    Luis Carlos López

    2010-03-01

    Full Text Available Introduction: Adverse drug reactions (ADRs are an important cause of morbidity and mortality among hospitalized patients.Objectives: This study was designed to describe the frequency, severity, and causality of ADRs in internal medicine units at a third-level university hospital.Materials and methods: A descriptive study was performed at internal medicine units, by means of a structured format, review of clinical records, and interview of hospitalized patients. The Naranjo algorithm was applied to patient adverse events to define causality. Additionally, ADRs were classified according to the Rawlins and Thompson criteria.Results: One hundred patients (50 men and 50 women were included in the study. Ninety nine (99 adverse events were found among the patients. The Naranjo algorithm was applied to adverse events, resulting in twenty nine (29 probable ADRs, twenty (20 possible ADRs and fifty (50 doubtful ADRs. Cardiovascular drugs and antibiotics were the most frequent therapeutic groups associated with ADRs. In addition, two preventable medication errors were identified.Conclusions: Frequency of ADRs was similar to the number reported in other studies in internal medicine units. It is necessary to systematize efforts of pharmacological surveillance in hospital wards, toward an opportune detection and prevention of ADRs.

  16. Optimal management of acute nonrenal adverse reactions to iodine-based contrast media

    OpenAIRE

    Nielsen YW; Thomsen HS

    2013-01-01

    Yousef W Nielsen, Henrik S Thomsen Department of Radiology, Copenhagen University Hospital Herlev, Copenhagen, Denmark Abstract: Acute adverse reactions to iodine-based contrast media occur within 60 minutes of administration. The reactions range from mild (flushing, arm pain, nausea/vomiting, headache) to moderate (bronchospasm, hypotension), and severe (cardiovascular collapse, laryngeal edema, convulsions, arrhythmias). Most acute adverse reactions occur in an unpredictable manner. Use of ...

  17. Optimal management of acute nonrenal adverse reactions to iodine-based contrast media

    OpenAIRE

    Thomsen, Henrik

    2013-01-01

    Yousef W Nielsen, Henrik S Thomsen Department of Radiology, Copenhagen University Hospital Herlev, Copenhagen, Denmark Abstract: Acute adverse reactions to iodine-based contrast media occur within 60 minutes of administration. The reactions range from mild (flushing, arm pain, nausea/vomiting, headache) to moderate (bronchospasm, hypotension), and severe (cardiovascular collapse, laryngeal edema, convulsions, arrhythmias). Most acute adverse reactions occur in an unpredictable manner. Use of...

  18. Adverse drug reaction profile of oseltamivir in children

    Directory of Open Access Journals (Sweden)

    Prashant S Dalvi

    2011-01-01

    Full Text Available Aim: To monitor and evaluate the pattern of ADRs to oseltamivir in pediatric population suffering from H1N1 influenza at a tertiary care hospital. Materials and Methods: Children offered oseltamivir for treatment and chemoprophylaxis were monitored for adverse events by direct questioning for symptoms and clinical examination on day 5 and day 10. Assessment of neurological events was done by asking the parents or guardians regarding development of specific symptoms. Adverse events obtained were analyzed for severity, causality and age-group wise. Results: Out of 191 children (median age, 3 years, 69 (36.1% developed ADRs. Most common symptoms were vomiting (16.2% followed by diarrhea (12.0%, ear disorders (8.9%, and insomnia (6.8%. The incidence of neuropsychiatric symptoms was 12.6% which were mild-to-moderate on severity scale. There was no significant difference in the incidence of adverse events between children less than 1 year and other age groups. Conclusion: Oseltamivir is well tolerated in Indian children with suspected or confirmed H1N1 influenza. Our study also indicates safety of oseltamivir in infants.

  19. Cardiovascular adverse reactions associated with Guarana: is there a causal effect?

    Science.gov (United States)

    Baghkhani, Leila; Jafari, Mahtab

    2002-01-01

    Herbal supplements have been used as adjuncts to medical therapy for many years by various cultures. Many consumers believe that because herbal supplements are natural products, they are somewhat safer or more effective than traditional prescribed medications. This is also one reason that alternative medicine is growing and gaining more popularity. On the other hand, adverse reactions to herbal supplements or their interactions with patients' current medications are no different than pharmaceutical medicines. We report a case of premature ventricular contraction associated with two herbal supplements. These products contained multiple different herbs and both included large doses of guarana. Guarana, which is found in some supplements marketed in U.S., contains a substantial amount of caffeine. Although the exact cause of tachycardia in our report is not proven, a large amount of caffeine consumption is thought to be a possible causal effect. The purpose of this report is to remind health care professionals to evaluate and educate patients on the use of herbal products and any potential adverse reactions, drug interactions, or possible toxicities. PMID:15277107

  20. The mechanisms of delayed onset type adverse reactions to oseltamivir.

    Science.gov (United States)

    Hama, Rokuro

    2016-09-01

    Oseltamivir is recommended for the treatment and prophylaxis of influenza in persons at higher risk for influenza complications such as individuals with diabetes, neuropsychiatric illnesses, and respiratory, cardiac, renal, hepatic or haematological diseases. However, a recent Cochrane review reported that reduction of antibody production, renal disorders, hyperglycaemia, psychiatric disorders, and QT prolongation may be related to oseltamivir use. The underlying mechanisms are reviewed. There is decisive evidence that administration of a clinically compatible dose of oseltamivir in mice challenged by a respiratory syncytial virus (RSV) that lacks a neuraminidase gene showed symptom-relieving effects and inhibition of viral clearance. These effects were accompanied by decreased level of T cell surface sialoglycosphingolipid (ganglioside) GM1 that is regulated by the endogenous neuraminidase in response to viral challenge. Clinical and non-clinical evidence supports the view that the usual dose of oseltamivir suppresses pro-inflammatory cytokines such as interferon-gamma, interleukin-6, and tumour necrosis factor-alpha almost completely with partial suppression of viral shedding in human influenza virus infection experiment. Animal toxicity tests support the clinical evidence with regard to renal and cardiac disorders (bradycardia and QT prolongation) and do not disprove the metabolic effect. Reduction of antibody production and cytokine induction and renal, metabolic, cardiac, and prolonged psychiatric disorders after oseltamivir use may be related to inhibition of the host's endogenous neuraminidase. While the usual clinical dose of zanamivir may not have this effect, a higher dose or prolonged administration of zanamivir and other neuraminidase inhibitors may induce similar delayed reactions, including reduction of the antibody and/or cytokine production. PMID:27251370

  1. Developing a departmental culture for reporting adverse incidents.

    Science.gov (United States)

    Bhatia, R; Blackshaw, G; Rogers, A; Grant, A; Kulkarni, R

    2003-01-01

    A simple, reproducible model for reporting adverse events was developed in order to promote cultural awareness and acceptance of risk management within the authors' department. A departmental proforma was created and prospective reporting of adverse events was encouraged. In the six months prior to commencing this study only four adverse incidents were reported. Following the introduction of the proforma 64 critical incidents and near-misses were reported in the one-year period. In conclusion a simple model for reporting critical incidents and near-misses has been established. This has fostered a cultural change within the department and all members of staff feel more comfortable with reporting such incidents. The process is seen as educational and an important part of continuing professional and departmental development. Protocols and changes in organisational practice have been developed to reduce and prevent the occurrence of adverse events and offer patients continuous improvement in care. PMID:12870255

  2. [Analysis of adverse reactions and pharmacovigilance research to parenterally administered shuxuening].

    Science.gov (United States)

    Yang, Wei; Xiang, Yong-Yang; Xie, Yan-Ming; Shen, Hao

    2013-09-01

    Parenterally administered Shuxuening is a commonly used Chinese medicine. There is a need to understand the characteristics of adverse drug reactions (ADRs) to it. 9 601 ADR cases reports were collected from the national adverse drug reaction monitoring center reported between January, 2005 and December, 2012. These included 326 serious ADR cases, accounting for 3.93% of the total. It was found that ADR reports increased annually from 2005, reaching a peak in the third quarter of 2009. The number of ADR cases reports were greatest in the third quarter of each year. ADRs in patients aged 60-74, accounted for 3 348 (34.87%) of all cases. 9 391(97.81%) cases were administered by intravenous infusion. In 8 431 cases, the dosage was in accordance with instructions. 61.61% ADR cases occurred on first administration. The ten most frequent symptoms were, rashes, itching, dizziness, palpitations, chills, allergic reactions, shortness of breath, nausea, phlebitis and vomiting. Systemic damage mainly affected the skin and its accessories damage, or the nervous system damage. Through the use of proportional reporting ratio (PRR) and Bayesian confidence propagation neural network (BCPNN) and propensity score applying generalized boosted models (GBM) to control for 17 confounding factors, analysis of the 10 kinds of ADRs found that for the ADR signals of dizziness, palpitations, phlebitis, and vomiting, BCPNN found that dizziness and phlebitis were early warning signals. This research found that in the 60-89 age group, higher dosages of parenterally administered Shuxuening gave rise to more phlebitis. This study provides important information for parenterally administered Shuxuening research, and guidance for its risk management. PMID:24471322

  3. Multiple adverse effects of pyridium: a case report.

    Science.gov (United States)

    Haigh, Charles; Dewar, James C

    2006-01-01

    Pyridium (phenazopyridine hydrochloride) is often prescribed as an analgesic in patients following trauma, surgery, or infections of the urinary tract. Pyridium toxicity has been previously reported, however, most cases result in a single adverse effect. Herein the authors describe an elderly patient who presented with simultaneous multiple adverse effects, including a previously undocumented myelosuppressive pancytopenia. PMID:16466130

  4. 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.

  5. 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 variab

  6. Cutaneous adverse drug reaction profile in a tertiary care out patient setting in Eastern India

    Directory of Open Access Journals (Sweden)

    Abanti Saha

    2012-01-01

    Conclusions: Cutaneous adverse drug reaction profile in this study is similar in many ways to studies conducted earlier in India. Incidence of life-threatening reactions like SJS-TEN was higher compared with studies conducted abroad. Reaction time and lesion patterns are helpful in identifying an offending drug in the setting of multiple drug therapy.

  7. Expectations for feedback in adverse drug reporting by healthcare professionals in the Netherlands

    NARCIS (Netherlands)

    Oosterhuis, Ingrid; van Hunsel, Florence P. A. M.; van Puijenbroek, Eugene P.

    2012-01-01

    Background: In 2010, the Netherlands Pharmacovigilance Centre Lareb received more than 4000 reports from healthcare professionals (HCPs). All HCPs received individual personal feedback containing information about the reported drug-adverse drug reaction (ADR) association. It is unclear what type of

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

    OpenAIRE

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

    2016-01-01

    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 ...

  9. 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...

  10. [Suggestions for prevention of adverse reactions after intravasal administration of iodinated contrast media].

    Science.gov (United States)

    Kuefner, Michael A; Heinrich, Marc; Bautz, Werner; Uder, Michael

    2008-01-01

    Iodinated contrast media are widely used in computed tomography and angiography. Adverse reactions such as contrast-medium induced nephropathy (CIN), anaphylactoid reactions and iodine-induced thyrotoxicosis are associated with intravasal administration of contrast agents. Iodinated contrast agents are generally considered to be safe, but in rare cases they can cause severe life threatening situations. In this review we present an overview about the incidence, pathways, and risk factors of adverse reactions. Simple schemes including hydration protocols for prevention of CIN, medication for prophylaxis of iodine-induced thyrotoxicosis with thyreostatics and anaphylactoid reactions with histamine antagonists and corticosteroids are suggested. PMID:19294866

  11. 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 

  12. ADVERSE REACTIONS TO VACCINES AND WAYS OF ITS PREVENTION

    Directory of Open Access Journals (Sweden)

    Yelyseyeva I. V

    2011-04-01

    Full Text Available The overview concerns allergic reaction on vaccines and possible ways of increasing safety of immunization on basis of use of local specific immunotherapies (SIT experience, particularly the sublingual route. The use of chemically altered allergens, allergoids; alternative routes of administration, particularly the sublingual route; use of novel adjuvants, such as CpG oligonucleotides and mycobacterial vaccines; other approaches, such as allergenic peptides, relevant T-cell epitope peptide immunotherapy; DNA vaccination, recombinant and engineered allergens, chimeric molecules and combined therapy are all approaches that have yielded positive results to increase safety of SIT and improve its efficacy.

  13. Cutaneous adverse drug reaction type erythema multiforme major induced by eslicarbazepine.

    Science.gov (United States)

    Massot, Andreu; Gimenez-Arnau, Ana

    2014-10-01

    Severe skin reactions occur less frequently with eslicarbazepine (ESL) than with the other aromatic anticonvulsants. We report the first case of cutaneous adverse drug reaction (CADR) to ESL and co-sensitization between ESL and betalactams. A 41-year-old white woman developed focal epilepsy due to a meningioma that was removed. As post-operatory complication, she suffered meningitis as well as a maculo-papular erythema caused by the treatment with meropenem. Subsequently, ESL was started and gradually increased until 800 mg/day. Twenty-five days later, the patient developed an Erythema Multiforme Major (EMM). Strong positive immediate reaction was induced by prick test with carbamazepine (CBZ) and ESL at 0.01 and 0.1% within 15 and 30 minutes; however the delayed reading at 48 hours was negative. The patient was not carrier of the HLA alleles A3101 and B1502 associated with CBZ induced EMM. The hypersensitivity pathogenic mechanism of EMM is unclear and a delayed hypersensitivity process is speculated. However, the patch and intradermal tests in our patient did not show a delayed reaction but an immediate cutaneous one. A first allergic episode may elicit a massive nonspecific activation of the immune system, providing an enhanced expression of co-stimulatory molecules that decreases the level of tolerance to other drugs. When prescribing ESL, we suggest ruling out previous CADR, especially to CBZ and oxcarbazepine but also other chemically unrelated drugs such as beta-lactams. PMID:25422574

  14. Ethnic differences in adverse drug reactions to asthma medications

    DEFF Research Database (Denmark)

    Hu, Yusun; Cantarero-Arévalo, Lourdes

    2016-01-01

    and to examine the relationship between ethnic background and ADRs to asthma medications. METHODS: MEDLINE was searched until March 2014. All types of studies reporting ADRs to asthma medications involving more than one ethnic group were included. Extracted information includes study designs, ethnic...... minority groups, few studies disaggregated information by ethnic background, and reports of ADRs to asthma medications in different ethnic groups were rare. We suggest that the inclusion of ADR analysis by different ethnic backgrounds is desirable....

  15. 7690例药品不良反应报告中ADR性别差异的回顾性分析%Retrospective analysis of gender differences in ADR of 7 690 cases of reported adverse drug reactions

    Institute of Scientific and Technical Information of China (English)

    孙言才; 刘琳琳; 史天陆; 王崇薇; 张蕾; 苏丹; 姜玲

    2015-01-01

    Objective To understand certain basic characteristics of the presented gender factors during the occurrence of adverse drug reactions (ADR)in patients for the implementation of drug safety monitoring,and to provide a reference for clinical therapy. Methods National Adverse Drug Reaction Monitoring Center database of a hospital from January 2005 to December 2010 which reported 7 690 cases of ADR was collected. A retrospective analysis was performed on the 7 690 cases of ADR reports,and gender factors were analyzed and eval-uated in correlation with other indicators such as patient age,drug class,anterior drugs,drug dosage form,route of administration,involving system/ organ. Results In 7 690 cases of ADR reports,4,052 cases were male,accounting for 52. 69%,3,638 cases were female,ac-counting for 47. 31%,and the male to female ratio was 1. 11 ∶ 1. 4 years from 2007 to 2010 the proportion of males was higher than that of fe-males,and 2 years from 2005 to 2006,male lower than female. In people aged 0 to 20,over the age of 50 years,the number of ADR cases was more in male than in female,and in people aged 21 to 50,the number of ADR cases was more in female than in male. The number of ADR cases caused by drugs affecting the blood and blood-forming system,traditional Chinese medicine,vitamins,etc. ,was more in male than in female,and the number of ADR cases caused by drugs affecting allergy and immune function,cardiovascular system drugs,respirato-ry system drugs,etc. was more in female than in male. ADR cases caused by seven kinds of drugs such as oxaliplatin for injection,fluoroura-cil injection,dexamethasone sodium phosphate injection were more male than female. ADR cases caused by levofloxacin hydrochloride injec-tion,levofloxacin lactate and sodium chloride injection,injection of ceftriaxone sodium were more female than male. ADR cases caused by six kinds of formulations like application suspensions,oral solutions,powder,etc. appeared more in male than in female

  16. Adverse Drug Reaction Reporting” Knowledge, Attitude and Practices of Community Pharmacy Dispensers in Dar es salaam, Tanzania

    OpenAIRE

    Shimwela, Grace Mng’ong’o

    2011-01-01

    Under reporting of adverse drug reactions (ADRs) by healthcare personnel is a common problem of many Pharmacovigilence programs. Lack of involvement of healthcare professionals such as pharmacists and other pharmaceutical dispensers has been cited as one of the reasons for under reporting. Pharmaceutical dispensers in the community pharmacies are in unique position by virtue of their training and profession to observe ADRs in patients, as many patients often try to avoid doctor consultation f...

  17. 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...

  18. OBESITY IS AN UNAVOIDABLE ADVERSE DRUG REACTION TO ATYPICAL ANTIPSYCHOTICS

    Directory of Open Access Journals (Sweden)

    Hemlata

    2015-03-01

    Full Text Available Atypical antipsychotics are an important advance in the treatment of schizophrenia and other psychiatric illness, and have become widely used as first - line pharmacotherapy for psychosis. This study is a longitudinal prospective observational study of ADRs of Atypical Antipsychotic drugs in patients of psychiatric illness. Information of ADRs was data based and collected from OPD. The noted ADRs were assessed by using Naranjo’s probability assessment scale, and WHO (UMC causality assessment scale. Majority of patients in this study belonged to 21 - 30 years age group which was 24% of the total. According to the severity of ADRs, majority of cases were reported of having weight gain 38. 46% followed by sedation 19. 23%, dry mouth 13. 46% and orthostatic hypote nsion 5. 76%. 88. 47% were reported as type A and 11. 53% were reported as type B. Definite (certain relationship was established in 30. 40% patients while probable in 57. 62% and 11. 53% ADRs were categorized as possible. The ADRs can be prevented by col lecting reliable information about their frequencies and possible risk factors.

  19. Adverse drug reaction suggests by a clinical vignette

    Directory of Open Access Journals (Sweden)

    Finestone AJ

    2011-07-01

    Full Text Available Albert J FinestoneTemple University School of Medicine, Philadelphia, PA, USAI had a three-lobe pneumonia and toxic encephalopathy in 2004. A lumbar puncture did not show meningitis. Magnetic resonance imaging showed a macroadenoma of the pituitary gland. Prolactin level was significantly elevated, making the diagnosis a functioning prolactinoma requiring treatment. Initially, I was treated with the dopamineagonist cabergoline, which is also used in much larger doses to treat Parkinsonism. Recent reports have indicated heart valve damage in Parkinsonism patients treated with ergot-derived dopamine-receptor agonists.

  20. Diversity and severity of adverse reactions to quinine: A systematic review.

    Science.gov (United States)

    Liles, Nathan W; Page, Evaren E; Liles, Amber L; Vesely, Sara K; Raskob, Gary E; George, James N

    2016-05-01

    Quinine is a common cause of drug-induced thrombocytopenia and the most common cause of drug-induced thrombotic microangiopathy. Other quinine-induced systemic disorders have been described. To understand the complete clinical spectrum of adverse reactions to quinine we searched 11 databases for articles that provided sufficient data to allow evaluation of levels of evidence supporting a causal association with quinine. Three reviewers independently determined the levels of evidence, including both immune-mediated and toxic adverse reactions. The principal focus of this review was on acute, immune-mediated reactions. The source of quinine exposure, the involved organ systems, the severity of the adverse reactions, and patient outcomes were documented. One hundred-fourteen articles described 142 patients with definite or probable evidence for a causal association of quinine with acute, immune-mediated reactions. These reactions included chills, fever, hypotension, painful acral cyanosis, disseminated intravascular coagulation, hemolytic anemia, thrombocytopenia, neutropenia, acute kidney injury, rhabdomyolysis, liver toxicity, cardiac ischemia, respiratory failure, hypoglycemia, blindness, and toxic epidermal necrolysis. One hundred-two (72%) reactions were caused by quinine pills; 28 (20%) by quinine-containing beverages; 12 (8%) by five other types of exposures. Excluding 41 patients who had only dermatologic reactions, 92 (91%) of 101 patients had required hospitalization for severe illness; 30 required renal replacement therapy; three died. Quinine, even with only minute exposure from common beverages, can cause severe adverse reactions involving multiple organ systems. In patients with acute, multi-system disorders of unknown origin, an adverse reaction to quinine should be considered. PMID:26822544

  1. Adverse drug reactions and organ damage: The liver.

    Science.gov (United States)

    Licata, Anna

    2016-03-01

    Drug-induced liver injury (DILI) is among the most challenging acute or chronic liver conditions to be handled by physicians. Despite its low incidence in the general population, DILI is a frequent cause of acute liver failure. As such, the possibility of DILI should be considered in all patients who present with acute liver damage, independent of any known pre-existing liver disease. DILI can be classified as intrinsic/dose-dependent (e.g., acetaminophen toxicity) or idiosyncratic/dose-independent, with the latter form being relatively uncommon. Amoxicillin-clavulanate is the antimicrobial that is most frequently associated with idiosyncratic DILI. Large, ongoing, prospective studies in western countries have reported other drugs associated with DILI, including nonsteroidal anti-inflammatory drugs, statins, and herbal and dietary supplements. An important safety issue, DILI is one of the most frequently cited reasons for cessation of drug development during or after preclinical studies and for withdrawal of a drug from the market. This review summarizes the epidemiology, risk factors, commonly implicated drugs, clinical features, and diagnosis of DILI, with the aim of aiding physicians in the management of this debated problem. Old and new biomarkers for DILI and pharmacogenetic studies are also described. PMID:26827101

  2. The logic of surveillance guidelines: an analysis of vaccine adverse event reports from an ontological perspective.

    Directory of Open Access Journals (Sweden)

    Mélanie Courtot

    Full Text Available BACKGROUND: When increased rates of adverse events following immunization are detected, regulatory action can be taken by public health agencies. However to be interpreted reports of adverse events must be encoded in a consistent way. Regulatory agencies rely on guidelines to help determine the diagnosis of the adverse events. Manual application of these guidelines is expensive, time consuming, and open to logical errors. Representing these guidelines in a format amenable to automated processing can make this process more efficient. METHODS AND FINDINGS: Using the Brighton anaphylaxis case definition, we show that existing clinical guidelines used as standards in pharmacovigilance can be logically encoded using a formal representation such as the Adverse Event Reporting Ontology we developed. We validated the classification of vaccine adverse event reports using the ontology against existing rule-based systems and a manually curated subset of the Vaccine Adverse Event Reporting System. However, we encountered a number of critical issues in the formulation and application of the clinical guidelines. We report these issues and the steps being taken to address them in current surveillance systems, and in the terminological standards in use. CONCLUSIONS: By standardizing and improving the reporting process, we were able to automate diagnosis confirmation. By allowing medical experts to prioritize reports such a system can accelerate the identification of adverse reactions to vaccines and the response of regulatory agencies. This approach of combining ontology and semantic technologies can be used to improve other areas of vaccine adverse event reports analysis and should inform both the design of clinical guidelines and how they are used in the future. AVAILABILITY: Sufficient material to reproduce our results is available, including documentation, ontology, code and datasets, at http://purl.obolibrary.org/obo/aero.

  3. Pattern of adverse reactions of antipsychotics in a tertiary care hospital

    OpenAIRE

    Meenakshy T. Viswanathan; Asha Sisupalan; Vidhukumar Karunakaran

    2016-01-01

    Background: This study was undertaken to analyse the pattern of adverse drug reactions (ADR) of antipsychotics among patients attending the psychiatry outpatient department of a tertiary care centre. Methods: Patients attending the psychiatry outpatient department who have been on treatment with one or more antipsychotics for more than 6 weeks were included in the study. Details about the prescription given in the previous appointment were collected. Various adverse effects associated with...

  4. Spontaneous adverse event reports associated with zolpidem in Australia 2001-2008.

    Science.gov (United States)

    Ben-Hamou, Monsif; Marshall, Nathaniel S; Grunstein, Ronald R; Saini, Bandana; Fois, Romano A

    2011-12-01

    A prominent media publicity cluster during 2007-2008 in Australia linked the common hypnotic zolpidem to adverse drug reaction reports of parasomnias, amnesia, hallucinations and suicidality. The collection of adverse drug reaction data through spontaneous reporting systems is a mainstay of drug safety monitoring, but a stimulated reporting event such as this often renders such data uninterpretable. As such, we aimed to investigate whether these associations were present before the media cluster and then to quantify the effect of stimulated reporting on those four specific outcomes. Using disproportionality analyses we compared zolpidem to all other drugs in the database, and then separately to each of all hypnotics, then all benzodiazepines, and then temazepam alone, and did so in every year from 2001 to 2008. Year-by-year analyses of Reporting odds ratios for zolpidem exposure and adverse events of interest, adjusted for a number of covariates, revealed an association between zolpidem exposure and parasomnias, amnesia and hallucination both before and after the cluster of media publicity beginning in early 2007. The odds ratios increased significantly after the media publicity for only parasomnias and amnesia. Suicidality was increased in some analyses, but limited data make this outcome difficult to interpret. We conclude that zolpidem adverse drug reaction reports have higher odds for parasomnia, amnesia, hallucination and perhaps suicidality compared to either all other drugs or hypnotics, even before the media publicity cluster. However, the extant literature and the limitations of these spontaneously reported adverse drug reaction data do not allow us to conclude that these events are related causally to zolpidem. PMID:21481053

  5. Predicting and detecting adverse drug reactions in old age: challenges and opportunities.

    Science.gov (United States)

    Mangoni, Arduino A

    2012-05-01

    Increased, often inappropriate, drug exposure, pharmacokinetic and pharmacodynamic changes, reduced homeostatic reserve and frailty increase the risk of adverse drug reactions (ADRs) in the older population, thereby imposing a significant public health burden. Predicting and diagnosing ADRs in old age presents significant challenges for the clinician, even when specific risk scoring systems are available. The picture is further compounded by the potential adverse impact of several drugs on more 'global' health indicators, for example, physical function and independence, and the fragmentation of care (e.g., increased number of treating doctors and care transitions) experienced by older patients during their clinical journey. The current knowledge of drug safety in old age is also curtailed by the lack of efficacy and safety data from pre-marketing studies. Moreover, little consideration is given to individual patients' experiences and reporting of specific ADRs, particularly in the presence of cognitive impairment. Pending additional data on these issues, the close review and monitoring of individual patients' drug prescribing, clinical status and biochemical parameters remain essential to predict and detect ADRs in old age. Recently developed strategies, for example, medication reconciliation and trigger tool methodology, have the potential for ADRs risk mitigation in this population. However, more information is required on their efficacy and applicability in different healthcare settings. PMID:22512705

  6. Chemotherapy-induced adverse drug reactions in oncology patients: A prospective observational survey

    Directory of Open Access Journals (Sweden)

    Deepti Chopra

    2016-01-01

    Full Text Available Background: Chemotherapy, a multimodal approach to oncological treatment, involves highly complex regimens and hence accounts to high susceptibility toward adverse drug reactions (ADRs. The present study aims to determine the prevalence of adverse events in patients treated with chemotherapy. Materials and Methods: Spontaneous ADR report of patients on antineoplastic drugs received in the past 2 years (January 2011-January 2013 were studied. These reports were analyzed for various carcinomas under treatment, medications used, types of ADRs, organ system involvement, severity, causality assessment, and preventability. Results: Over a period of 2 years, a total 591 cases were received with an incidence of 58.6%. The prevalence of ADRs was more in female patients (73.6% as compared to men. ADRs mostly occurred in the age group of 41-50 years (27.4%. Patients treated for breast carcinoma (39.1% reported the highest incidence of ADRs. Cisplatin (19.6% was found to be the most common offending drug. The most common ADR reported was nausea and vomiting (23%. Gastroenterology (40.1% was the most affected system. About 50.2% of the ADRs required treatment and 12.9% ADRs were considered serious. Causality assessment revealed that 80% of the ADRs were possible. About 86.97% cases were found to be mild, and 51% were not preventable. Conclusion: The success of chemotherapy comes with the word of caution regarding toxicities of antineoplastic drugs. Pharmacovigilance of these drugs needs to be explored, and use of preventative measures needs to be enhanced in order to reduce the incidence and severity of ADRs.

  7. A Prospective Study of Adverse Drug Reactions in 1 Month–12 Years Old Pediatric Patients

    Directory of Open Access Journals (Sweden)

    Asawari Raut

    2015-03-01

    Full Text Available Adequate controlled clinical trials in pediatric population, especially in oncology and vaccinations are still insufficient due to ethical considerations. Certain conditions in children in general and in Indian children in particular, suggested the need for Adverse Drug Reaction (ADR monitoring. Thus this study was aimed to investigate the incidence of ADRs in pediatric populations. A prospective spontaneous reporting study was conducted over a period of six months from October 2012 to March 2013 in pediatric inpatients ward of Bharati Hospital in Pune. Reported ADRs were assessed for its causality by using WHO causality assessment scale, and its severity by using Hart wig Severity Scale. A total of 107 suspected ADRs were reported and evaluated from 54 patients, showing an overall incidence of 4.75%. Incidence rate of ADRs during hospitalization was 4.13%, while ADRs induced hospitalization was 0.62%. The gastrointestinal system (48.59% was the most affected, and antibiotics was the most common the drug class associated to ADRs. In term of causality, 55.14% of the reactions were classified as possible, while in term of severity, 64.49% were classified as moderate. Most patients (60.75% recovered from the incidence. Although the prevalence and severity of ADRs in pediatrics populations is reported to be higher than those of in adults, the incidence of ADRs in our study was only 4.75% which is lower than those of reported in adults, this may due to the spontaneous reporting system that used in this study.

  8. Identifying plausible adverse drug reactions using knowledge extracted from the literature.

    Science.gov (United States)

    Shang, Ning; Xu, Hua; Rindflesch, Thomas C; Cohen, Trevor

    2014-12-01

    Pharmacovigilance involves continually monitoring drug safety after drugs are put to market. To aid this process; algorithms for the identification of strongly correlated drug/adverse drug reaction (ADR) pairs from data sources such as adverse event reporting systems or Electronic Health Records have been developed. These methods are generally statistical in nature, and do not draw upon the large volumes of knowledge embedded in the biomedical literature. In this paper, we investigate the ability of scalable Literature Based Discovery (LBD) methods to identify side effects of pharmaceutical agents. The advantage of LBD methods is that they can provide evidence from the literature to support the plausibility of a drug/ADR association, thereby assisting human review to validate the signal, which is an essential component of pharmacovigilance. To do so, we draw upon vast repositories of knowledge that has been extracted from the biomedical literature by two Natural Language Processing tools, MetaMap and SemRep. We evaluate two LBD methods that scale comfortably to the volume of knowledge available in these repositories. Specifically, we evaluate Reflective Random Indexing (RRI), a model based on concept-level co-occurrence, and Predication-based Semantic Indexing (PSI), a model that encodes the nature of the relationship between concepts to support reasoning analogically about drug-effect relationships. An evaluation set was constructed from the Side Effect Resource 2 (SIDER2), which contains known drug/ADR relations, and models were evaluated for their ability to "rediscover" these relations. In this paper, we demonstrate that both RRI and PSI can recover known drug-adverse event associations. However, PSI performed better overall, and has the additional advantage of being able to recover the literature underlying the reasoning pathways it used to make its predictions. PMID:25046831

  9. Double-blind evaluation of two commercial hypoallergenic diets in cats with adverse food reactions.

    Science.gov (United States)

    Leistra, M; Willemse, T

    2002-12-01

    The aim of this study was to evaluate two commercially available selected-protein-source diets as maintenance diets in cats with dermatological manifestations of adverse food reactions. Twenty cats with a confirmed adverse food reaction were tested in a double-blind manner. An adverse food reaction was diagnosed when, after recovery with a home-cooked elimination diet, the signs relapsed after a challenge with their previous dietary components, and re-disappeared on a second elimination diet period. Hereafter the cats were blind and randomly challenged with two commercial hypoallergenic diets. Relapse of the clinical signs was seen in eight cats (40%) on a lamb and rice diet and in 13 cats (65%) on a chicken and rice diet (P>0.05). Neither one of the commercial diets was as effective in controlling the skin problems as the home-cooked elimination diet. The study confirms that commercial hypoallergenic diets are adequate for maintenance. PMID:12468310

  10. Prospective Observational Study of Adverse Drug Reactions of Anticancer Drugs Used in Cancer Treatment in a Tertiary Care Hospital

    OpenAIRE

    V. K. Saini; Sewal, R. K.; Ahmad, Yusra; B Medhi

    2015-01-01

    Adverse drug reactions associated with the use of anticancer drugs are a worldwide problem and cannot be ignored. Adverse drug reactions can range from nausea, vomiting or any other mild reaction to severe myelosuppression. The study was planned to observe the suspected adverse drug reactions of cancer chemotherapy in patients aged >18 years having cancer attending Postgraduate Institute of Medical Education and Research, Chandigarh. During the study period, 101 patients of breast cancer and ...

  11. Report on Adverse Drug Reactions Induced by Pediatric Intravenous Transfusion and Nursing Countermeasures%小儿静脉用药引发的药品不良反应报告及护理对策

    Institute of Scientific and Technical Information of China (English)

    党玉梅; 汪友兰; 张会娥

    2016-01-01

    OBJECTIVE:To investigate the adverse drug reactions ( ADR ) induced by pediatric intravenous transfusion and nursing countermeasures .METHODS:The clinical manifestation form of 125 cases of ADR induced by pediatric intravenous transfusion admitted into Xiaogan Municipal Central Hospital ( hereinafter referred to as “our hospital”) from Mar.2013 to Mar.2015 were analyzed, and the related nursing countermeasures were discussed . RESULTS:Of the 125 ADR cases, the primary disease was respiratory disease .The highest incidence of ADR was anti-infection drugs, and digestive system was the main involved organs and (or) systems.The clinical manifestations of ADR cases induced by pediatric intravenous transfusion were closely associated with the categories of drugs and pediatric individual differences , the medical and nursing staff were suppose to strengthen the observation and nursing measures.CONCLUSIONS: The incidence of ADR cases induced by pediatric intravenous transfusion is relatively high.It is necessary for the clinic to attach more importance to this aspect and take the nursing measures during the whole process of administration , so as to reduce the incidence of ADR .%目的:了解小儿静脉用药引发的常见不良反应(adverse drug reaction,ADR)及护理措施。方法:分析孝感市中心医院(以下简称“我院”)2013年3月—2015年3月125例小儿静脉用药引发的ADR临床表现形式,探讨护理对策。结果:在发生ADR的125例患儿中,主要原发性疾病为呼吸系统疾病,ADR发生率最高的药品为抗感染药,主要累及器官和(或)系统为消化系统。小儿静脉用药ADR的发生及其临床表现形式与药物的种类、儿童个体差异密切相关,要求医、护人员加强观察,并做好护理措施。结论:儿童在进行药物静脉用药时容易发生 ADR,需引起临床重视,采取给药前、给药中以及给药后全程护理措施,以降低ADR的发生率。

  12. Analysis of Adverse Reaction of Analgesics, Antipyretics and Non-Steroidal Anti-Inflammatory Drugs Prescribed by Physicians of Health Care Facilities in Podilskyi Region during 2015

    OpenAIRE

    Stepaniuk, N. H.; Hladkykh, F. V.; Basarab, O. V.

    2016-01-01

    The problem of medicines rational use exists all over the world. It concerns particularly analgesics, antipyretics and non-steroidal anti-inflammatory drugs (NSAIDs). In Ukraine the side effects caused by non-steroidal antiphlogistics rank the second place according to the prevalence among all registered cases.The objective of the research was to analyze adverse drug reaction report forms concerning adverse reactions caused by the use of NSAIDs, analgesics, antipyretics, and were submitted du...

  13. 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

  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. Knowledge, attitude and practices toward pharmacovigilance and adverse drug reactions in postgraduate students of Tertiary Care Hospital in Gujarat

    OpenAIRE

    Het B Upadhyaya; Vora, Mukeshkumar B.; Jatin G Nagar; Patel, Pruthvish B.

    2015-01-01

    Being key health care professional, physicians, pharmacist and nurses have immense responsibility in reporting adverse drug reaction (ADR). Therefore, the study objective was to evaluate the knowledge, attitude and practices (KAP) toward pharmacovigilance and ADRs of postgraduate students of our institute. A cross-sectional questionnaires based study was carried out in postgraduate students of the clinical department at tertiary care hospital attached with Govt. Medical College, Vadodara, Guj...

  16. Implant based differences in adverse local tissue reaction in failed total hip arthroplasties: a morphological and immunohistochemical study

    OpenAIRE

    Perino, Giorgio; Ricciardi, Benjamin F.; Jerabek, Seth A.; Martignoni, Guido; Wilner, Gabrielle; Maass, Dan; Goldring, Steven R.; Purdue, P Edward

    2014-01-01

    Background Adverse local tissue reaction (ALTR) is characterized by periprosthetic soft tissue inflammation composed of a mixed inflammatory cell infiltrate, extensive soft tissue necrosis, and vascular changes. Multiple hip implant classes have been reported to result in ALTR, and clinical differences may represent variation in the soft tissue response at the cellular and tissue levels. The purpose of this study was to describe similarities and differences in periprosthetic tissue structure,...

  17. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder

    DEFF Research Database (Denmark)

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn; Lundh, Andreas; Gøtzsche, Peter C

    2014-01-01

    OBJECTIVE: To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. DESIGN: Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in...... marketing approval. DATA SOURCES: Clinical study reports obtained from the EMA in 2011. RESULTS: Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly...

  18. 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.

  19. Analysis of adverse reactions and complications of transcatheter uterine artery embolization (TUAE) for uterine fibroids

    International Nuclear Information System (INIS)

    Objective: To investigate the adverse reactions and complications as well as their preventive and therapeutic measures of TUAE for uterine fibroids. Methods: One hundred and eighty-two patients with uterine fibroids were treated by TUAE. Bilateral uterine arteries were embolized using lipiodol-pingyangmycin emulsion (LPE), together with Gelfoam particles. All patients were hospitalized for 3 to 10 days after TUAE and were followed up for 1 to 24 months to observe the adverse reactions and complications. Results: Adverse reactions of TUAE included postembolization syndrome ( n 182); urinary irritation ( n = 24), and hyporrhea of vagina ( n = 25 ) . Complications of TUAE included expelling of necrotic fibroids per vagina ( n = 5 ); urinary retention ( n = 10); urinary tract infection ( n = 1 ); ulcer of labia minora ( n = 1 ); ecchymosis and ulceration on buttock ( n = 1), and secondary infection of chocolate cyst of ovary. ( n = 1 ). All the above-mentioned side effects of TUAE recovered to normal after expectant or especial treatment without any sequels left. Conclusion: The adverse reactions of TUAE are reversible and the complications of TUAE are preventable and curable

  20. 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 peop

  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. 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

  3. Ocular adverse effects of Topiramate: Two case reports

    Directory of Open Access Journals (Sweden)

    Mandal Ananya

    2008-01-01

    Full Text Available Topiramate, an antiepileptic drug is reported to cause various ocular adverse effects like acute onset myopia, glaucoma. Visual field defect is an uncommon, serious treatment emergent adverse effect. We are reporting two cases of suspected topiramate induced visual field defects. Both the cases were on topiramate for more than 6 months as add-on therapy at daily doses ranging from 100-150mg. The presenting complaints were insidious onset visual disturbances. Diagnosis was based of temporal association with drug intake, clinical examination and investigations. Automated perimetry revealed bilateral superior quadrantic and arcuate field defects in the two cases respectively. Marked improvement with drug dechallenge was noted which was also corroborated by perimetry. Using Naranjo′s ADR Probability Scale, both cases revealed a "probable" association with topiramate. This report intends to improve awareness amongst clinicians to facilitate early diagnosis and intervention.

  4. Retrospective evaluation of adverse transfusion reactions following blood product transfusion from a tertiary care hospital: A preliminary step towards hemovigilance

    Directory of Open Access Journals (Sweden)

    Praveen Kumar

    2013-01-01

    Full Text Available Background: The goal of hemovigilance is to increase the safety and quality of blood transfusion. Identification of the adverse reactions will help in taking appropriate steps to reduce their incidence and make blood transfusion process as safe as possible. Aims : To determine the frequency and type of transfusion reactions (TRs occurring in patients, reported to the blood bank at our institute. Materials and Methods : A retrospective review of all TRs reported to the blood bank at the All India Institute of Medical Sciences, between December 2007 and April 2012 was done. All the TRs were evaluated in the blood bank and classified using standard definitions. Results: During the study period a total of 380,658 bloods and blood components were issued by our blood bank. Out of the total 196 adverse reactions reported under the hemovigilance system, the most common type of reaction observed was allergic 55.1% (n = 108, followed by febrile non-hemolytic transfusion reaction (FNHTR 35.7% (n = 70. Other less frequently observed reactions were Anaphylactoid reactions 5.1% (n = 10, Acute non-immune HTRs 2.6% (n = 5, Circulatory overload 0.5% (n = 1, Transfusion related acute lung injury 0.5% (n = 1, Delayed HTRs 0.5% (n = 1. Not a single case of bacterial contamination was observed. Conclusion: The frequency of TRs in our patients was found to be 0.05% (196 out of 380,658. This can be an underestimation of the true incidence because of under reporting. It should be the responsibility of the blood transfusion consultant to create awareness amongst their clinical counterpart about safe transfusion practices so that proper hemovigilance system can be achieved to provide better patient care.

  5. Elucidating Reasons for Resident Underutilization of Electronic Adverse Event Reporting.

    Science.gov (United States)

    Hatoun, Jonathan; Suen, Winnie; Liu, Constance; Shea, Sandy; Patts, Gregory; Weinberg, Janice; Eng, Jessica

    2016-07-01

    Reasons for resident underutilization of adverse event (AE) reporting systems are unclear, particularly given frequent resident exposure to AEs and near misses (NMs). Residents at an academic medical center were surveyed about AEs/NMs, barriers to reporting, patient safety climate, and educational interventions. A total of 350 of 527 eligible residents (66%) completed the survey; 77% of respondents reported involvement in an AE/NM, though only 43% had used the reporting system. Top barriers to reporting were not knowing what or how to report. Surgeons reported more than other residents (surgery, 61%; medical, 38%; hospital-based, 15%; P systems were unlikely to change after reporting (surgery, 49%; medical, 28%; hospital-based. 18%; P system effectiveness, and educational preferences. PMID:25753451

  6. Serious adverse events reported for anti-obesity medicines

    DEFF Research Database (Denmark)

    Aagaard, L; Hallgreen, C E; Hansen, Ebba Holme

    2016-01-01

    BACKGROUND: Use of anti-obesity medicines has been linked with serious cardiac and psychiatric adverse events (AEs). Spontaneous reports can provide information about serious, rare and unknown AEs occurring after time of marketing. In Europe, information about AEs reported for anti...... to 2014 and located in EV were analysed. AE data were categorised with respect to time, age and sex of patient/consumer, type of reporter, category and seriousness of reported AEs and medicines. Consumer AE reports were compared with reports from other types of reporters with respect to age and sex...... to share and seriousness of AEs, type of AEs (SOC) and medicines (ATC level 5). CONCLUSIONS: Many serious AEs were found for anti-obesity medicines in EV, and consumers contributed with a relatively high share of reports. Although several products have been withdrawn from the market and new medicines...

  7. 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

    UNLABELLED: At present, there is no European report on clinically relevant systemic reactions due to the regular use of allergen immunotherapy (AIT), administered either subcutaneously or sublingually (SCIT and SLIT, respectively) outside clinical trials. Using an electronic survey and a "harmoni......UNLABELLED: At present, there is no European report on clinically relevant systemic reactions due to the regular use of allergen immunotherapy (AIT), administered either subcutaneously or sublingually (SCIT and SLIT, respectively) outside clinical trials. Using an electronic survey 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...... Activities) dictionary to harmonize the reporting of all adverse systemic reactions in this survey. The SurveyMonkey® online instrument was used by participant doctors to submit information directly to a blinded central database. THREE QUESTIONNAIRES WERE GENERATED: i) the Doctor Questionnaire, ii) the...

  8. Analysis of adverse drug reactions of atypical antipsychotic drugs in psychiatry OPD

    Directory of Open Access Journals (Sweden)

    Kiran G Piparva

    2011-01-01

    Full Text Available Background: Novel atypical antipsychotics are superior to conventional antipsychotics as they significantly reduce both positive and negative symptoms of schizophrenia and have lower risk of extrapyramidal symptoms (EPS. However, these drugs have separate set of adverse drug reactions (ADRs. Therefore, this study was carried out to assess these ADRs, which can have impact on long-term compliance and achieving successful treatment. Materials and Methods: A prospective study of analysis of ADR of atypical antipsychotic drugs was carried out in the psychiatry outpatient department. Patients of psychotic disorder (any age, either sex, who were prescribed atypical antipsychotic drugs, were included. Those who were prescribed conventional antipsychotics or combinations of antipsychotics were excluded from the study. Apart from spontaneously reported ADRs, a questionnaire related to the likely ADR was used and patients′ responses were recorded in the case record form. Results: Totally 93 ADRs were recorded from 84 prescriptions. Majority of the ADRs (82 out of 93 were seen with risperidone and olanzepine, as they were the commonly prescribed drugs. Weight gain, dizziness, sleep disturbance and appetite disturbance accounted for nearly 78% of the total events. With risperidone (at 4-6 mg/day and olanzepine (at 10-15 mg/day, gastrointestinal and sleep disturbance were observed in the initial (within 7 days to 2-3 months after treatment course of treatment, while EPS, fatigue, seizure, increased frequency of micturition and dizziness were observed after long-term (3-9 months use. Conclusion: The present study adds to the existing information on the prevalence of adverse effects of atypical antipsychotic drugs. Role of active surveillance in post-marketing phase is also emphasized.

  9. 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.

  10. Statin safety: an appraisal from the adverse event reporting system.

    Science.gov (United States)

    Davidson, Michael H; Clark, John A; Glass, Lucas M; Kanumalla, Anju

    2006-04-17

    The adverse event (AE) profiles of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin) agents are of great interest, in particular the most recently approved statin, rosuvastatin. The forwarding of reports of AEs has been shown to be influenced by several reporting biases, including secular trend, the new drug reporting effect, product withdrawals, and publicity. Comparative assessments that use AE reporting rates are difficult to interpret under these circumstances, because such effects can themselves lead to marked increases in AE reporting. Consequently, many comparative reporting rate analyses are best carried out in conjunction with other metrics that put reporting burden into context, such as report proportion. All-AE reporting rates showed a temporal profile that resembled those of other statins when marketing cycle and secular trend were taken into account. A before-and-after cerivastatin withdrawal comparison showed a substantial increase in the reporting of AEs of interest for the statin class overall. Report proportion analyses indicated that the burden of rosuvastatin-associated AEs was similar to that for other statin agents. Analyses of monthly reporting rates showed that the reporting of rosuvastatin-associated rhabdomyolysis and renal failure have increased following AE-specific mass media publicity. Postrosuvastatin AE reporting patterns were comparable to those seen with other statins and did not resemble cerivastatin. PMID:16581327

  11. Assessing the association between omalizumab and arteriothrombotic events through spontaneous adverse event reporting

    OpenAIRE

    Ali AK; Hartzema AG

    2012-01-01

    Ayad K Ali, Abraham G HartzemaDepartment of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, USABackground: Omalizumab is a monoclonal antibody, indicated for the treatment of severe allergic asthma. In Europe, there have been concerns about the cardiovascular safety of omalizumab. The objective of this study was to analyze the association between omalizumab and arterial thrombotic events in a spontaneous adverse drug reaction reporting database...

  12. A web resource for mining HLA associations with adverse drug reactions: HLA-ADR.

    Science.gov (United States)

    Ghattaoraya, Gurpreet S; Dundar, Yenal; González-Galarza, Faviel F; Maia, Maria Helena Thomaz; Santos, Eduardo José Melo; da Silva, Andréa Luciana Soares; McCabe, Antony; Middleton, Derek; Alfirevic, Ana; Dickson, Rumona; Jones, Andrew R

    2016-01-01

    Human leukocyte antigens (HLA) are an important family of genes involved in the immune system. Their primary function is to allow the host immune system to be able to distinguish between self and non-self peptides-e.g. derived from invading pathogens. However, these genes have also been implicated in immune-mediated adverse drug reactions (ADRs), presenting a problem to patients, clinicians and pharmaceutical companies. We have previously developed the Allele Frequency Net Database (AFND) that captures the allelic and haplotype frequencies for these HLA genes across many healthy populations from around the world. Here, we report the development and release of the HLA-ADR database that captures data from publications where HLA alleles and haplotypes have been associated with ADRs (e.g. Stevens-Johnson Syndrome/toxic epidermal necrolysis and drug-induced liver injury). HLA-ADR was created by using data obtained through systematic review of the literature and semi-automated literature mining. The database also draws on data already present in AFND allowing users to compare and analyze allele frequencies in both ADR patients and healthy populations. The HLA-ADR database provides clinicians and researchers with a centralized resource from which to investigate immune-mediated ADRs.Database URL: http://www.allelefrequencies.net/hla-adr/. PMID:27189608

  13. Hospitalization in older patients due to adverse drug reactions -the need for a prediction tool.

    Science.gov (United States)

    Parameswaran Nair, Nibu; Chalmers, Leanne; Peterson, Gregory M; Bereznicki, Bonnie J; Castelino, Ronald L; Bereznicki, Luke R

    2016-01-01

    Adverse drug reactions (ADRs) represent a major burden on society, resulting in significant morbidity, mortality, and health care costs. Older patients living in the community are particularly susceptible to ADRs, and are at an increased risk of ADR-related hospitalization. This review summarizes the available evidence on ADR-related hospital admission in older patients living in the community, with a particular focus on risk factors for ADRs leading to hospital admission and the need for a prediction tool for risk of ADR-related hospitalization in these individuals. The reported proportion of hospital admissions due to ADRs has ranged from 6% to 12% of all admissions in older patients. The main risk factors or predictors for ADR-related admissions were advanced age, polypharmacy, comorbidity, and potentially inappropriate medications. There is a clear need to design intervention strategies to prevent ADR-related hospitalization in older patients. To ensure the cost-effectiveness of such strategies, it would be necessary to target them to those older individuals who are at highest risk of ADR-related hospitalization. Currently, there are no validated tools to assess the risk of ADRs in primary care. There is a clear need to investigate the utility of tools to identify high-risk patients to target appropriate interventions toward prevention of ADR-related hospital admissions. PMID:27194906

  14. 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

  15. 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

    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...... 59 patients with adverse reactions to polyacrylamide gel, and 54 biopsies and 2 cytology specimens from 28 control subjects with no adverse reactions. Samples from 5 patients and 4 controls could not be investigated for presence of bacteria owing to limited material. Samples from the remaining 54...... in bacteriologically investigated samples from 53 of 54 patients (98%), and in none of the 24 controls (0%). The bacteria were lying in small clusters, which in symptomatic lesions were detected up to 5 years postinjection. Conclusions. Commensal bacteria of low virulence are capable of producing long-term infection...

  16. Genetic polymorphisms affect efficacy and adverse drug reactions of DMARDs in rheumatoid arthritis.

    Science.gov (United States)

    Zhang, Ling Ling; Yang, Sen; Wei, Wei; Zhang, Xue Jun

    2014-11-01

    Disease-modifying antirheumatic drugs (DMARDs) and biological agents are critical in preventing the severe complications of rheumatoid arthritis (RA). However, the outcome of treatment with these drugs in RA patients is quite variable and unpredictable. Drug-metabolizing enzymes (dihydrofolate reductase, cytochrome P450 enzymes, N-acetyltransferases, etc.), drug transporters (ATP-binding cassette transporters), and drug targets (tumor necrosis factor-α receptors) are coded for by variant alleles. These gene polymorphisms may influence the pharmacokinetics, pharmacodynamics, and side effects of medicines. The cause for differences in efficacy and adverse drug reactions may be genetic variation in drug metabolism among individuals. Polymorphisms in drug transporter genes may change the distribution and excretion of medicines, and the sensitivity of the targets to drugs is strongly influenced by genetic variations. In this article, we review the genetic polymorphisms that affect the efficacy of DMARDs or the occurrence of adverse drug reactions associated with DMARDs in RA. PMID:25144752

  17. Ontological representation of adverse drug reactions using the Foundational Model of Anatomy.

    Science.gov (United States)

    Bousquet, Cédric; Gasperina, Philippe; Trombert, Béatrice; Clavel, Lucienne; Kumar, Anand; Rodrigues, Jean Marie

    2009-01-01

    In a previous work we proposed a categorial structure for the representation of adverse drug reactions consisting of 16 semantic categories and 20 relations. We present an implementation of this categorial structure in Protégé based on four WHO-ART system organ classes: Gastro-intestinal system disorders, Liver and biliary system disorders, Central & peripheric nervous system disorders, and Psychiatric disorders. We compared classification according to anatomy using SNOMED CT within the PharmARTS tool and the FMA with the Pellet reasoner. This ontology contains 210 concepts for Gastroenterology, 66 concepts for Psychiatry and 85 concepts for Neurology. Classification of disorders located in the upper gastro intestinal tract was similar using both SNOMED CT and the FMA. This work is a first step towards the comparison of two models of anatomy within a common ontology of adverse drug reactions. PMID:19745363

  18. [Enlightenment of adverse reaction monitoring on safety evaluation of traditional Chinese medicines].

    Science.gov (United States)

    Song, Hai-bo; Du, Xiao-xi; Ren, Jing-tian; Yang, Le; Guo, Xiao-xin; Pang, Yu

    2015-04-01

    The adverse reaction monitoring is important in warning the risks of traditional Chinese medicines at an early stage, finding potential quality problems and ensuring the safe clinical medication. In the study, efforts were made to investigate the risk signal mining techniques in line with the characteristics of traditional Chinese medicines, particularly the complexity in component, processing, compatibility, preparation and clinical medication, find early risk signals of traditional Chinese medicines and establish a traditional Chinese medicine safety evaluation system based on adverse reaction risk signals, in order to improve the target studies on traditional Chinese medicine safety, effective and timely control risks and solve the existing frequent safety issue in traditional Chinese medicines. PMID:26281610

  19. Clinical Analysis of Adverse Drug Reactions between Vincristine and Triazoles in Children with Acute Lymphoblastic Leukemia

    OpenAIRE

    Yang, Lihua; Yu, Lihua; Chen, Xinxin; Hu, Yanqun; Wang, Bin(Department of Physics and Astronomy, Shanghai Jiao Tong University, Shanghai, 200240, China)

    2015-01-01

    Background Vincristine (VCR) is a major chemotherapy drug for treatment of childhood acute lymphoblastic leukemia (ALL). Triazole antifungal drugs (AFD) are the main agents for the prevention/treatment of invasive fungal infection (IFI), a common complication during the treatment of ALL. This study investigated the adverse drug reactions (ADRs) between VCR and AFD. Material/Methods A retrospective study was performed on 68 children with ALL (39 boys and 29 girls, median age: 5 years) who were...

  20. Biomarkers for cancer-related fatigue and adverse reactions to chemotherapy in lung cancer patients

    OpenAIRE

    Sha, Fei; ZHUANG, SHANSHAN; Zhou, Li; Zhang, Liqun; YANG, YUXIAN; ZHANG, SHENGQI; Jiang, Yi; QIU, GUODONG; Chen, Chen; ZHENG, JIETING; ZHANG, SHUYAO

    2014-01-01

    This study was conducted to investigate the biomarkers that appear to be correlated with cancer-related fatigue (CRF) and the adverse reactions (ADRs) to chemotherapy. A total of 100 lung cancer patients were selected and CRF prior to and following chemotherapy was evaluated. The plasma levels of tumor necrosis factor (TNF)-α and interleukin (IL)-1 and the level of 17-hydroxycorticosteroid (17-OHCS) in the urine were analyzed and correlated with CRF and the ADRs associated with chemotherapy. ...

  1. Treatments that generate higher number of adverse drug reactions and their symptoms

    OpenAIRE

    Lucía Fernández-López; Javier Navarro-Zaragoza; María Falcón; Aurelio Luna

    2015-01-01

    Objectives: Adverse drug reactions (ADRs) are an important cause of morbidity and mortality worldwide and generate high health costs. Therefore, the aims of this study were to determine the treatments which produce more ADRs in general population and the main symptoms they generate. Methods: An observational, cross-sectional study consisting in performing a self-rated questionnaire was carried out. 510 patients were asked about the treatments, illnesses and ADRs, they had suffered from. Resul...

  2. Concept Extraction to Identify Adverse Drug Reactions in Medical Forums: A Comparison of Algorithms

    OpenAIRE

    Metke-Jimenez, Alejandro; Karimi, Sarvnaz

    2015-01-01

    Social media is becoming an increasingly important source of information to complement traditional pharmacovigilance methods. In order to identify signals of potential adverse drug reactions, it is necessary to first identify medical concepts in the social media text. Most of the existing studies use dictionary-based methods which are not evaluated independently from the overall signal detection task. We compare different approaches to automatically identify and normalise medical concepts in ...

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

    OpenAIRE

    Orten-Luiten, van, A.C.B.; A. Janse; R. A. M. Dhonukshe-Rutten; 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 people. Furthermore, prevalences of drug use and vitamin D deficiency are estimated. Methods In a population of 873 community-dwelling Dutch geriatric outpatients, we explored the cross-sectional relations...

  4. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder

    DEFF Research Database (Denmark)

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn; Lundh, Andreas; Gøtzsche, Peter C

    2014-01-01

    identifiable in all formats of adverse event data in clinical study reports. Suicide attempts presented in tables included both definitive and provisional diagnoses. Suicidal ideation and preparatory behaviour were obscured in some tables owing to the lack of specificity of the medical coding dictionary......OBJECTIVE: To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. DESIGN: Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in...... marketing approval. DATA SOURCES: Clinical study reports obtained from the EMA in 2011. RESULTS: Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly...

  5. 药品不良反应行为主体利益博弈分析%Analysis of Benefit Game on Adverse Drug Reaction Subjects

    Institute of Scientific and Technical Information of China (English)

    刘花; 冯变玲; 杨世民

    2013-01-01

    目的:研究药品不良反应监测工作中监管部门和报告者的博弈关系.方法:采用博弈模型进行分析.结果:我国应对现行的处罚政策做适当调整,引入奖励制度.结论:我国应建立奖罚分明的药品不良反应报告制度.%Objective: To analyze the game relationship between the regulatory authorities and the reporters in the monitoring of adverse drug reaction. Method: A game model was used in the game analysis. Result: The punishment policy in the current regulation for adverse drug reaction monitoring needed some appropriate adjustments, and the reward system should be introduced. Conclusion: Strict rules for reward and punishment in adverse drug reaction reporting system should be established in our country.

  6. Relationship between serum acetaminophen concentration and N-acetylcysteine-induced adverse drug reactions.

    Science.gov (United States)

    Zyoud, Sa'ed H; Awang, Rahmat; Sulaiman, Syed Azhar Syed; Khan, Halilol Rahman Mohamed; Sawalha, Ansam F; Sweileh, Waleed M; Al-Jabi, Samah W

    2010-09-01

    Intravenous N-acetylcysteine is usually regarded as a safe antidote. However, during the infusion of the loading dose, different types of adverse drug reactions (ADR) may occur. The objective of this study was to investigate the relation between the incidence of different types of ADR and serum acetaminophen concentration in patients presenting to the hospital with acetaminophen overdose. This is a retrospective study of patients admitted to the hospital for acute acetaminophen overdose over a period of 5 years (1 January 2004 to 31 December 2008). Parametric and non-parametric tests were used to test differences between groups depending on the normality of the data. SPSS 15 was used for data analysis. Of 305 patients with acetaminophen overdose, 146 (47.9%) were treated with intravenous N-acetylcysteine and 139 (45.6%) were included in this study. Different types of ADR were observed in 94 (67.6%) patients. Low serum acetaminophen concentrations were significantly associated with cutaneous anaphylactoid reactions but not other types of ADR. Low serum acetaminophen concentration was significantly associated with flushing (p acetaminophen concentrations between patients with and without the following ADR: gastrointestinal reactions (p = 0.77), respiratory reactions (p = 0.96), central nervous reactions (p = 0.82) and cardiovascular reactions (p = 0.37). In conclusion, low serum acetaminophen concentrations were associated with higher cutaneous anaphylactoid reactions. Such high serum acetaminophen concentrations may be protective against N-acetylcysteine-induced cutaneous ADR. PMID:20374238

  7. Serious adverse event reporting in investigator-initiated clinical trials.

    Science.gov (United States)

    Wallace, Sophie; Myles, Paul S; Zeps, Nikolajs; Zalcberg, John R

    2016-04-01

    Reporting adverse events (AEs) and serious AEs (SAEs) are practical steps to ensure safety for volunteers and patients in medical research involving medications, treatments and devices. However, the burden and cost of reporting should be proportionate with the public health benefit of this information. Unfortunately, in Australia there is clear evidence of ever-increasing requirements from sponsors and ethics committees to report AEs and SAEs unnecessarily, leading to a decrease in the uptake of research, particularly less well funded investigator-initiated trials. We believe that individual AE reports to ethics committees serve no useful purpose, because in most cases the study group identity (drug exposure) is not known in studies with blinded treatment arms and their value is limited. Pragmatic, investigator-initiated Phase IV clinical trials of post-marketed drugs or devices are needed to understand their role in everyday clinical practice. In this setting, the workload and costs of systematic, complete reporting of all AEs and SAEs (independent of whether these are treatment-related) is wasteful, and mostly unnecessary. A trial data safety and monitoring committee is in the unique position of being able to review safety information according to the blinded treatment arms of the study. This enables safety data to be analysed appropriately and a summary report provided to the trial steering committee, principal investigators and the relevant ethics committees in a meaningful way. Defined trial endpoints do not need to be reported as safety events (because they are being properly monitored and analysed). PMID:27031396

  8. Adverse drug reactions in elderly patients with cognitive disorders: A systematic review.

    Science.gov (United States)

    Kanagaratnam, Lukshe; Dramé, Moustapha; Trenque, Thierry; Oubaya, Nadia; Nazeyrollas, Pierre; Novella, Jean-Luc; Jolly, Damien; Mahmoudi, Rachid

    2016-03-01

    Elderly subjects with cognitive disorders are at particularly high risk of adverse drug reactions (ADRs). The objectives of our systematic review were to describe the prevalence of ADRs in elderly patients with cognitive disorders, the different types of ADRs and the medications suspected of involvement; to describe whether the ADRs were preventable or not, and to identify risk factors for occurrence of ADRs in this population. A bibliographic search was performed in the following databases: PubMed, Embase, Google Scholar, Opengrey and Scopus. The search included all publications up to and including 4th February 2015, with no specific start date specified. Studies concerning ADRs in elderly patients with cognitive disorders or dementia were included. Two senior authors identified eligible studies and extracted data independently. In total, 113 studies were identified by the bibliographic search, of which six full-text articles were retained and analyzed. Prevalence of ADRs ranged from 4.8 to 37%. The main ADRs reported were neurological and psychological disorders, gastro-intestinal disorders, dermatological and allergic disorders, falls, renal and urinary disorders, cardiovascular disorders, metabolic disorders and electrolyte imbalance, and hemorrhagic events. The medications most commonly suspected of involvement in the ADRs were drugs affecting the nervous system, cardiovascular drugs, anticoagulants, and painkillers. Medical prescriptions should take into account the presence of Alzheimer's disease and related syndromes. Compliance should systematically be evaluated, and cognitive disorders need to be better recognized. Therapeutic education of patients and/or their caregiver is key to management of elderly patients with cognitive disorders. PMID:26857880

  9. Adverse Drug Reactions to First Line Anti-Tubercular Drugs - A Pharmacovigilance Study

    Directory of Open Access Journals (Sweden)

    Dr. Umeshchandra C Honnaddi

    2016-02-01

    Full Text Available Introduction: Tuberculosis is one of the major health problems in India and developing countries. It is the second leading infectious cause of morbidity and mortality in the world.Objective: The present study was undertaken to study the Adverse Drug Reactions (ADRs to first line Anti-tubercular drugs (ATTs prescribed to tuberculosis patients admitted to Medicine Department, BTGH, attached to M.R. Medical College, Gulbarga.Materials and Methods: A Prospective Observational study was carried among tuberculosis patients on Directly Observed Short Course Chemotherapy (DOTS, admitted to Medicine Department, BTGH, attached to M.R. Medical College; Gulbarga.120 Patients were included during the study period of 9 months from 1st October 2014 to 30th June 2015. The data was collected in a Proforma which included questionnaire.Results: A total of 120 tuberculosis patients on DOTS were enrolled for the study. Out of 107 patients, 63 patients (58.87% developed ADRs. Out of 63 patients, 32 patients (51% developed Gastro-intestinal problems, 14 patients developed CNS problems (22%, 11 patients (18% developed Hepatitis, 4 patients (6% developed Fever and 2 patients (3% developed Pancreatitis. The most serious ADR was Hepatitis.Conclusion: Results of the study reveals that about 58.87% of patients developed ADRs during the study period. These ADRs will lead to stoppage of drugs, development of Drug resistance and Therapeutic Failure. If a proper Pharmacovigilance system is implemented in the hospital, most of the patients may report their ADRs and thereby we can improve the patient adherence and treatment outcome.

  10. 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.

  11. To Discuss the Adverse reaction of Chinese Patent Drug%浅谈中成药的不良反应

    Institute of Scientific and Technical Information of China (English)

    刘伦栋

    2014-01-01

    To discuss the adverse reaction of Chinese patent drug, to study and analysis the adverse reaction of Chinese patent drug in clinic, Chinese patent drug, adverse reaction should be valued and prevent drug abusing.%探讨中成药的不良反应,分析研究中成药在临床应用中的不良反应,且对中成药的不良反应应重视并防止滥用。

  12. Pharmacogenetic potential biomarkers for carbamazepine adverse drug reactions and clinical response.

    Science.gov (United States)

    Jaramillo, Nancy Monroy; Galindo, Ingrid Fricke; Vázquez, Alberto Ortega; Cook, Helgi Jung; LLerena, Adrián; López, Marisol López

    2014-01-01

    Carbamazepine (CBZ) is a first-line widely used anticonvulsant. It has a narrow therapeutic index and exhibits considerable interindividual and interethnic variability in clinical efficacy and adverse drug reactions including potentially life-threatening hypersensitivity reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis. The most important pharmacogenetic finding is related to the association of CBZ-induced hypersensitivity with human leukocyte antigens (HLA class I and II alleles). Moreover, genotyping for HLA-B*15:02 allele is required prior to initiating CBZ in Asians and Asian ancestry patients, demonstrating the usefulness of biomarkers to avoid adverse drug reactions. On the other hand, in order to explain the differences in the clinical response to CBZ, genetic polymorphisms in phase I (CYP3A4, CYP3A5 and EPHX1) and phase II (UGT2B7) metabolising enzymes have been assessed; additionally, the influence of transporters (ABCB1 and ABCC2), receptors (PXR) and other drug targets (voltage- gated Na+ channels) in CBZ clinical response has been evaluated. To date, these studies are controversial and require further investigations to clarify the functional role of these polymorphisms as potential biomarkers in regard to CBZ therapy. PMID:24406279

  13. Telaprevir may induce adverse cutaneous reactions by a T cell immune-mediated mechanism.

    Science.gov (United States)

    Federico, Alessandro; Aitella, Ernesto; Sgambato, Dolores; Savoia, Alfonso; De Bartolomeis, Fabio; Dallio, Marcello; Ruocco, Eleonora; Pezone, Luciano; Abbondanza, Ciro; Loguercio, Carmela; Astarita, Corrado

    2015-01-01

    The HCV protease inhibitor telaprevir associated with peginterferon-alpha and ribavirin, was widely used in the recent past as standard treatment in HCV genotype-1 infected patients. Telaprevir improves the sustained virology response rates, but at the same time increases the frequency of adverse cutaneous reactions. However, mechanisms through which telaprevir induces cutaneous lesions are not yet defined. A 50-year-old woman, affected by HCV genotype 1b, was admitted to our Department for a telaprevir-related severe cutaneous eruptions, eight weeks after starting a triple therapy (telaprevir associated with Peginterferon-alpha and ribavirin). Mechanisms of cutaneous reactions were investigated by skin tests with non-irritating concentrations of telaprevir and by activating in vitro T lymphocyte with different concentrations. Immediate and delayed responses to skin testing were negative, but the drug-induced lymphocytes activation was significantly higher as compared to patient's baseline values and to parallel results obtained in three healthy subjects (p < 0.05). In conclusion, adverse cutaneous reactions of our patient were caused by a telaprevir-induced T-cell dependent immune mechanism. PMID:25864225

  14. Evaluation of adverse reactions in dogs following intravenous mesenchymal stem cell transplantation

    OpenAIRE

    Kang, Min Hee; Park, Hee Myung

    2014-01-01

    Background Recent studies have assessed the therapeutic potential and drawbacks of mesenchymal stem cells (MSCs). The adverse reactions of intravenous transplantation of bone marrow (BM)-derived MSCs were examined at varying doses and frequencies of administration. Nine healthy beagle dogs were purchased from a commercial laboratory. The dogs were distributed equally (n = 3 per group) and randomly into three groups. All dogs received allogeneic BM-derived MSCs: 2 × 106 once (group A), 2 × 107...

  15. Rapidly Progressing Severe Cutaneous Adverse Reaction With Acute Kidney Injury After Drug Exposure: An Uncommon Presentation.

    Science.gov (United States)

    Rodgers, Bradley K; Kumar, Avinash B

    2016-01-01

    Toxic epidermal necrolysis syndrome (TEN) is a rare severe cutaneous adverse drug reaction that involves skin and mucous membranes. We describe a case of TEN presenting with stage III acute kidney injury, rhabdomyolysis, and acute respiratory failure likely triggered by allopurinol for recently diagnosed gout. Prompt diagnosis, multidisciplinary management, including aggressive resuscitation, cardiorespiratory support, intravenous immunoglobulin therapy, and daily wound care resulted in a positive outcome despite a predicted mortality greater than 60%. Although allopurinol is a known triggering agent, TEN presenting with rhabdomyolysis and acute kidney injury is rare. PMID:24832386

  16. Adverse reactions associated with a Fuenzalida-Palacios rabies vaccine: a quasi-experimental study

    OpenAIRE

    Bonito Rosuita Fratari; Oliveira Neide Mattar de; Nishioka Sérgio Andrade

    2004-01-01

    The Fuenzalida-Palacios rabies vaccine has been used in South America for rabies post-exposure prophylaxis. To determine the frequency of adverse reactions associated with this vaccine compared to a control group a quasi-experimental study was carried out in Uberlândia, Brazil, from May 1997 to April 1998. Victims of bites or other injuries by dogs or other mammals and who received or not post-exposure prophylaxis with Fuenzalida-Palacios rabies vaccine were compared as to the occurrence of a...

  17. Surface Characterization of Retrieved Metal-on-Metal Total Hip Implants from Patients with Adverse Reaction to Metal Debris

    Directory of Open Access Journals (Sweden)

    Maria Burbano

    2014-03-01

    Full Text Available The use of metal-on-metal (MoM total hip implants has decreased recently due to reports of high failure rates and adverse local tissue reaction (ALTR. It has been hypothesized that wear metal debris released from CoCr bearing surfaces may provoke delayed hypersensitivity reactions. The goal of this study is to evaluate the microscopic bearing surface characteristics of implants revised due to evidence of ALTR. The bearing surface of each head and cup was analyzed using multiple microscopy techniques for characterization of the surface features. The presence of severe mechanical scratching was a common characteristic found in all of the implants evaluated. Mechanical factors seemed to be the prevalent failure mode related to the appearance of ALTR with this particular set of retrieved implants.

  18. Knowledge, Attitude and Practices towards Pharmacovigilance and Adverse Drug Reactions in health care professional of Tertiary Care Hospital, Bhavnagar

    Directory of Open Access Journals (Sweden)

    Dr.Mukeshkumar B Vora

    2014-11-01

    Full Text Available Purpose: Adverse drug reactions (ADRs are adverse consequences of drug therapy. ADRs are representing a major concern of health systems in terms of early recognition, proper management and prevention. Under reporting of Adverse Drug Reactions (ADRs is a common problem in Pharmacovigilance programs. Poor perceptions of doctors about ADRs and risk management have contributed to high rate of ADR under-reporting in India. Underreporting has also been attributed to lack of time to doctor, misconceptions about spontaneous reporting and lack of information on how to report, where to report and a lack of availability of report forms, and also physicians' attitudes to ADRs. The objective of our study was to evaluate the knowledge, attitude and practices (KAP of health care professional towards Pharmacovigilance and adverse drug reactions in a tertiary care hospital, Bhavnagar, Gujarat, India. Methods: A cross-sectional questionnaires based study was carried out in Post graduate students and faculties of tertiary care hospital attached with Govt. Medical College, Bhavnagar, Gujarat. Post graduate students and faculties of different clinical subjects working in the tertiary care teaching hospital, Bhavnagar, Gujarat (India were enrolled and present throughout in study. 22 questionnaires about knowledge, attitude and practices towards ADRs and Pharmacovigilance were developed and peer viewed of all questionnaires by expert faculties from Pharmacology department. We were contacted directly to post graduate students and faculties of respective clinical department, questionnaires were distributed, 30 minutes time given to filled form. Any clarification and extra time was needed, provided to them. The filled KAP questionnaires were analyzed in question wise and their percentage value was calculated by using Microsoft excel spread sheet and online statistical software. Results: In study, postgraduate residents (n=81 and faculties (n=63 from different clinical

  19. Anaphylaxis following intravenous ranitidine: A rare adverse reaction of a common drug

    Directory of Open Access Journals (Sweden)

    Deepti Chopra

    2014-01-01

    Full Text Available Ranitidine hydrochloride is a widely used drug that is generally well-tolerated. Anaphylaxis is rarely observed with ranitidine. We report a case who developed severe anaphylaxis following single dose of intravenous ranitidine. The article highlights the importance of recognition of this serious adverse event and re-emphasizes the need for cautious use of drugs, especially in those with known history of allergy.

  20. Thrombocytopenia induced by a taurine-containing energy drink: an adverse reaction to herbal medicine

    OpenAIRE

    Federico Pasin; Emanuela Porro; Francesco Frattini; Pierpaolo Vescovi; Massimo Franchini; Paolo Sansoni

    2014-01-01

    Thrombocytopenia is a well-recognized adverse effect of many drugs. The association of thrombocytopenia with herbal remedies, nutritional supplements, foods and beverages, complementary or alternative medicines, has been rarely described. There are reports of thrombocytopenia caused by quinine-containing beverages, cow�s milk, cranberry juice, Jui, a Chinese herbal tea, Lupinus termis bean and tahini. A definite evidence of a causal association with thrombocytopenia is warranted; nevertheless...

  1. Prescribing pattern and adverse drug reactions monitoring in patients with rheumatoid arthritis in a tertiary care hospital

    OpenAIRE

    Lakshmi Prabha M; Geetha Rani A; Meenakshi Balasubramanian; Ezhil Ramya J

    2016-01-01

    Background: Rheumatoid arthritis is a chronic inflammatory arthritis which requires lifelong treatment to prevent the damage to joints and to maintain day to day functioning of patients. All the drugs used in the treatment of rheumatoid arthritis show significant toxicity and hence it is very important that their use require regular monitoring for adverse reactions. The present study is designed to estimate the prescribing pattern and the occurrence of adverse drug reactions in patients with ...

  2. 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.

  3. Silicone gel breast implant adverse event reports to the Food and Drug Administration, 1984-1995.

    OpenAIRE

    Brown, S.L.; Parmentier, C M; Woo, E K; Vishnuvajjala, R L; Headrick, M L

    1998-01-01

    OBJECTIVES: To characterize the adverse event reports on silicone gel breast implants (SGBIs), including death reports, submitted to the Food and Drug Administration (FDA) from 1984 through 1995 and to analyze changes in the type and complexity of reports following extensive media coverage of breast implants. METHODS: The authors analyzed mandatory and voluntary reports from the adverse events reporting system for medical devices at the FDA. RESULTS: In 1988, adverse event reports related to ...

  4. Assessing the association between omalizumab and arteriothrombotic events through spontaneous adverse event reporting

    Directory of Open Access Journals (Sweden)

    Ali AK

    2012-05-01

    Full Text Available Ayad K Ali, Abraham G HartzemaDepartment of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, USABackground: Omalizumab is a monoclonal antibody, indicated for the treatment of severe allergic asthma. In Europe, there have been concerns about the cardiovascular safety of omalizumab. The objective of this study was to analyze the association between omalizumab and arterial thrombotic events in a spontaneous adverse drug reaction reporting database in the US.Methods and materials: Reports of arterial thrombotic events submitted to the US Food and Drug Administration's Adverse Event Reporting System (AERS between 2004 and 2011 were retrieved and analyzed by the reporting odds ratio data mining algorithm. The reporting odds ratio of arterial thrombotic events for omalizumab was compared with specific asthma medications and all drugs in the AERS. Values ≥2 were considered significant safety signals. The Medical Dictionary for Regulatory Activities Preferred Terms were used to identify arterial thrombotic events (eg, stroke, myocardial infarction.Results: In total, 293,783 reports of arterial thrombotic events were retrieved (about 2% of all adverse drug reaction reports, corresponding to 2274 asthma drug-arterial thrombotic events pairs (omalizumab, 222; inhaled corticosteroids [ICS], 131; long-acting beta-agonists [LABA], 102; single-device combination ICS-LABA, 506; inhaled short-acting beta-agonists [SABA], 475; oral SABA, 6; inhaled antimuscarinics [AMC], 477; single-device combination AMC-SABA, 127; xanthines, 50; leukotriene modifiers, 174; and mast cell stabilizers, 4. Reporting odds ratio and 95% confidence interval values for omalizumab compared with other asthma drugs and all drugs in AERS were 2.75 (2.39–316 and 1.09 (0.95–1.24, respectively. Omalizumab ranked second after ICS in the risk of arterial thrombotic events, followed by AMC, AMC-SABA, and ICS-LABA.Conclusion: Omalizumab is

  5. 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. PMID:27292007

  6. Developmental Regression and Autism Reported to the Vaccine Adverse Event Reporting System

    Science.gov (United States)

    Woo, Emily Jane; Ball, Robert; Landa, Rebecca; Zimmerman, Andrew W.; Braun, M. Miles

    2007-01-01

    We report demographic and clinical characteristics of children reported to the US Vaccine Adverse Event Reporting System (VAERS) as having autism or another developmental disorder after vaccination. We completed 124 interviews with parents and reviewed medical records for 31 children whose records contained sufficient information to evaluate the…

  7. Assessment of a self-designed protocol on patients with adverse reactions to beta-lactam antibiotics.

    Science.gov (United States)

    González, J; Guerra, F; Moreno, C; Miguel, R; Daza, J C; Sánchez Guijo, P

    1992-01-01

    Suspected adverse reactions to beta-lactam antibiotics are the most frequent reason for consultation in relation WMH drug allergy. Because of their therapeutical usefulness and wide use, we developed a protocol for confirmation or exclusion of this type of allergy. The proposed protocol is based on clinical, causal and laboratory criteria that are used to assign scores from 0 to 9 points. Patients with scores between 0 and 3 are considered to be highly prone to beta-lactam antibiotic allergy and are given an alternative therapy that is selected by applying skin provocation tests (SPT). Those with a score of 9 points are excluded. Finally, those with scores between 4 and 8 are subjected to skin tests with 5 antigens (penicillin G, ampicillin, cephalothin, Penkit PPL and Penkit MDM); if they give negative results they are subsequently subjected to oral provocation with beta-lactam antibiotics. In this work we report the results obtained from 150 patients analysed for 28 variables altogether. The results allowed us to rule out adverse reactions in 94 patients. Only 9 individuals yielded positive skin tests, and only one gave a positive oral provocation (bronchospasm, 6 hours after subjection to the test). The usefulness of the proposed protocol, the profitability of the test applied and the mechanisms involved are assessed. PMID:1292326

  8. Thrombocytopenia induced by a taurine-containing energy drink: an adverse reaction to herbal medicine

    Directory of Open Access Journals (Sweden)

    Federico Pasin

    2014-02-01

    Full Text Available Thrombocytopenia is a well-recognized adverse effect of many drugs. The association of thrombocytopenia with herbal remedies, nutritional supplements, foods and beverages, complementary or alternative medicines, has been rarely described. There are reports of thrombocytopenia caused by quinine-containing beverages, cow�s milk, cranberry juice, Jui, a Chinese herbal tea, Lupinus termis bean and tahini. A definite evidence of a causal association with thrombocytopenia is warranted; nevertheless not always there is provided probable or possible evidence in the association with thrombocytopenia. We report the first case, to our knowledge, of thrombocytopenia induced by taurine, present in an energy drink prescribed to our patient as tonic treatment.

  9. Study on the Application of Common Signal Detection Methods for Adverse Drug Reaction Reports%药品不良反应报告常用信号检测方法应用研究

    Institute of Scientific and Technical Information of China (English)

    汤榕; 李林贵; 孙维红; 顾希; 杜慧; 王晓霞

    2012-01-01

    OBJECTIVE: To provide reference for safe and rational use of drugs in the clinic and further drug safety risk evaluation. METHODS: 8 795 cases were collected from ADR monitoring network in our region from 2007 to 2010, and determined quantitatively by using proportional reporting ratio (PPR), Reporting odds ratio(ROR)and Bayesian confidence propagation neural network (BCPNN). The suspicious signal were compared and analyzed, and the quantitative signal detection method based on autonomous reporting system database and the scientific ADR signal detection way were explored. RESULTS & CONCLUSION: 3 common methods were all adopted to detect 869 types of Drug-ADR and 66 types of Drugs-ADR quantitatively. Part of signal could be detected. The results of PRR and ROR method were similar, and BCPNN method was different from them significantly. The signal strengths of 3 methods were not identical.%目的:为指导临床安全、合理用药和进一步评价药品安全风险提供参考.方法:通过收集我区2007-2010年药品不良反应(ADR)监测网络ADR报告8 795份,运用频数法中的比例报告(PRR)法、报告比值比(ROR)法和贝叶斯判别可信区间递进神经网络模型(BCPNN)法进行定量检测,对生成的可疑信号进行比较分析,探索以自发呈报系统数据库为基础的定量信号检测方法的运用和科学的ADR信号检测途径.结果与结论:通过对869种Drug-ADR组合和66种Drugs-ADR组合进行3种常用方法信号定量检测,发现对部分已知信号能够检出,PRR法、ROR法结果相近,BCPNN法差别较大,3种方法信号强度各不相同.

  10. Evaluation of adverse drug reactions in HIV positive patients in a tertiary care hospital

    Directory of Open Access Journals (Sweden)

    Anshu Kumar Jha

    2015-01-01

    Full Text Available Context: The advancement and development of new drugs and treatment strategies increase the risk of unusual Adverse Events (AEs in HIV patients. Aims: The objective of our study was to assess the incidence, types and nature of AEs in HIV positive subjects. Settings and Design: Patients with WHO stage IV disease irrespective of the CD4 cell count, or WHO stage III disease with a CD4 cell count <350 cell/cu. Mm, or, WHO stage I or II disease with a CD4 cell count of <200 cells/cu. mm, and on prior anti-retroviral therapy for not more than six months preceding the observation date, were included in the study. After initiation of therapy, the patients were examined for the occurrence any adverse events including the type and severity, or any other abnormal laboratory findings. Causality assessment of the adverse events was done using the Naranjo′s scale. Results: Out of 327 patients studied prospectively, 43 patients developed AEs. Out of these, 23 (53.5% were males and 20 (46.5% were females. A total of 53 (16.21% AEs were reported. Antitubercular drugs caused the maximum AEs (28.3% followed by zidovudine (20.7%, nevirapine (15.0% and efavirenz (5.6%. Stavudine, ethambutol, sulfamethoxazole and trimethoprim, and atazanavir were also responsible for 3.7% of AEs individually. Causality assessment done according to the Naranjo′s scale revealed that 66.04% AEs were ′probable′ and 33.96% were ′possible′. Conclusions: Anemia, hepatitis and dermatological adverse effects are the most common AEs. Antitubercular drugs contributed significantly for the incidence of AEs in these patients. Frequency of AEs was slightly more in males compared to females.

  11. Adverse reactions after cosmetic lip augmentation with permanent biologically inert implant materials.

    Science.gov (United States)

    Hoffmann, C; Schuller-Petrovic, S; Soyer, H P; Kerl, H

    1999-01-01

    Augmentation of lips is a common aesthetic procedure that is mostly performed with alloplastic materials or autologous tissue. Various alloplastic injectable implants have been developed for soft tissue augmentation without surgery. Most biologic materials are resorbed within a few months, fluid silicone may migrate, and autologous fat is not ideal for fine contouring of the lips. The search for a biocompatible, permanent, nontoxic, and biologically inert filler material led to the development of some new materials for subdermal or intradermal implantation. Recently Bioplastique, Artecoll, and Gore-Tex have been well established and recommended by many authors. Although these materials meet most of the characteristics that constitute an ideal injectable prosthetic material, we describe 3 examples of adverse reactions after their implantation into lips. PMID:9922021

  12. 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. PMID:26215671

  13. Pattern of adverse drug reactions due to cancer chemotherapy in a tertiary care hospital in South India

    Directory of Open Access Journals (Sweden)

    Ajitha Sharma

    2015-01-01

    Full Text Available Purpose: Studies regarding pattern of adverse drug reactions (ADRs in cancer chemotherapy patients are scarce in India. This study was conducted to evaluate the pattern of occurrence of ADRs due to cancer chemotherapy in hospitalized patients and to assess the causality, severity, predictability, and preventability of these reactions. Materials and Methods: This was a retrospective, descriptive study and the occurrence and nature of ADR, suspected drug, duration of hospital stay and outcome were noted from case records. These ADRs were assessed for causality using both World Health Organization (WHO causality assessment scale and Naranjo′s algorithm. The severity and preventability of the reported reactions were assessed using modified Hartwig and Siegel scale and modified Schumock and Thornton scale respectively. Results: Five hundred ADRs were recorded from 195 patients. Most common ADRs were infections (22.4%, nausea/vomiting (21.6% and febrile neutropenia (13%. Platinum compounds, nitrogen mustards, taxanes, antibiotics and 5-fluorouracil were the most common drugs causing ADRs. WHO causality assessment scale showed 65% of the reactions to be "probable" and 35% to be "possible," while Naranjo′s algorithm indicated that 65.6% of ADRs were "probable" and 34.4% were "possible". Modified Hartwig and Siegel scale showed most reactions (41.4% to be of "moderate level 4(a" severity, while 30.6% of reactions were of "mild level 1" severity. About 30.8% of the ADRs were "definitely preventable" according to the modified Schumock and Thornton scale. Conclusion: ADRs are most important causes of morbidity and mortality and increase the economic burden on patient and society. By careful ADR monitoring, their incidence can be decreased.

  14. Knowledge, attitude and practices toward pharmacovigilance and adverse drug reactions in postgraduate students of Tertiary Care Hospital in Gujarat

    Directory of Open Access Journals (Sweden)

    Het B Upadhyaya

    2015-01-01

    Full Text Available Being key health care professional, physicians, pharmacist and nurses have immense responsibility in reporting adverse drug reaction (ADR. Therefore, the study objective was to evaluate the knowledge, attitude and practices (KAP toward pharmacovigilance and ADRs of postgraduate students of our institute. A cross-sectional questionnaires based study was carried out in postgraduate students of the clinical department at tertiary care hospital attached with Govt. Medical College, Vadodara, Gujarat (India. A total of 22 questionnaires about KAP toward ADRs and pharmacovigilance were developed and peer viewed of all questionnaires by expert faculties from our institute. We were contacted directly to postgraduate students of respective clinical department; questionnaires were distributed and taken back after 30 min. The filled KAP questionnaires were analyzed in question wise and their percentage value was calculated by using Microsoft Excel spreadsheet. Postgraduate residents (n = 101 from different clinical departments were enrolled in the study. Average 34.83% correct and 64.08% incorrect knowledge about ADRs and pharmacovigilance and an average 90.76% students were agreed to reporting ADRs is necessary, mandatory and increased patient′s safety. Only 7.92% of postgraduate doctors were reported ADR at institute or ADR reporting center. We concluded that postgraduate students have a better attitude toward reporting ADRs, but have lack of knowledge and poor practices of ADRs. The majority of postgraduate students were felt ADR reporting and monitoring is very important, but few had ever reported ADRs because of lack of sensitization and knowledge of pharmacovigilance and ADR.

  15. Jinlong capsule decreases adverse reactions after transcatheter arterial chemoembolization (TACE) in patients with hepatocellular carcinoma

    Institute of Scientific and Technical Information of China (English)

    Wukui Huang; Dengyao Liu; Lina You; Shufa Yang; Mo Liu; Peng Gu; Pingju Wang; Baikere Pahaerding; Xiwen Fan

    2015-01-01

    Objective The aim of this study was to analyze whether Jinlong capsule could decrease adverse reac-tions after transcatheter arterial chemoembolization (TACE) in patients with hepatocel ular carcinoma. Methods Eighty-two patients with hepatocel ular carcinoma were randomly divided into the control group and experimental group. On the first day after TACE, the experimental group started receiving four Jinlong capsules oral y three times daily, whereas the control group did not receive the treatment. Results The incidences of erythropenia and thrombocytopenia in the experimental group was lower than those in the control group (P = 0.040 and 0.033, respectively). The dif erences in serum levels of amino-transferase, albumin, potassium, and sodium between the two groups were significant (P = 0.034, 0.034, 0.013, and 0.044, respectively). The mean durations of stomachache and abdominal distension in the experimental group was significantly shorter than those in the control group (P = 0.004 and 0.021, respec-tively). However, there were no significant dif erences in the incidences of nausea, fever, and vomiting between the two groups (P = 0.490, 0.495, and 0.585, respectively). Conclusion The reduction in the incidence rate and duration of partial adverse reactions after TACE was observed in hepatocel ular carcinoma patients treated with Jinlong capsule compared to untreated patients, suggesting possible beneficial ef ects exerted by Jinlong capsule on the reduction of TACE-induced liver damage, thereby improving liver function and, consequently, the quality of life.

  16. A possible role for cysteinyl-leukotrienes in non-ionic contrast media induced adverse reactions

    International Nuclear Information System (INIS)

    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-FcεRI 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

  17. 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.

  18. Adverse reactions of HMG—CoA reductase inhibitors as a consequence of drug—drug interaction

    Institute of Scientific and Technical Information of China (English)

    IkedaT

    2002-01-01

    Use of HMG-CoA reductase inhibitors in treating hypercholesterolemia is a well-established therapy.Presently,atorvastatin,fluvastatin,lovastatin,simvastatin and pravastatin are used clinically.Cerivastatin was pulled from the market in 2001 due to its higher risk of inducing rhabdomyolysis than all other drugs.Hepatotoxicity and rhabdomyolysis are the known adverse reactions by these drugs.However,the hepatotoxicity has been regarded to be mild,and is now referred to as transaminitis.Rhadomyolysis occurs in rare instances but is sometimes life threatening as a result of renal failure caused by myoglobinemia.The mechanism leading to rhabdomyolysis is unknown but in many of the reported cases,increased plasma concentratinos of thes drugs have been observed,most likely as a consequence of drug interaction.Inhibition of CYP 3A4 and UGT is believed to be the reason for this interaction.

  19. Acute disseminated encephalomyelitis onset: evaluation based on vaccine adverse events reporting systems.

    Directory of Open Access Journals (Sweden)

    Paolo Pellegrino

    Full Text Available OBJECTIVE: To evaluate epidemiological features of post vaccine acute disseminated encephalomyelitis (ADEM by considering data from different pharmacovigilance surveillance systems. METHODS: The Vaccine Adverse Event Reporting System (VAERS database and the EudraVigilance post-authorisation module (EVPM were searched to identify post vaccine ADEM cases. Epidemiological features including sex and related vaccines were analysed. RESULTS: We retrieved 205 and 236 ADEM cases from the EVPM and VAERS databases, respectively, of which 404 were considered for epidemiological analysis following verification and causality assessment. Half of the patients had less than 18 years and with a slight male predominance. The time interval from vaccination to ADEM onset was 2-30 days in 61% of the cases. Vaccine against seasonal flu and human papilloma virus vaccine were those most frequently associated with ADEM, accounting for almost 30% of the total cases. Mean number of reports per year between 2005 and 2012 in VAERS database was 40±21.7, decreasing after 2010 mainly because of a reduction of reports associated with human papilloma virus and Diphtheria, Pertussis, Tetanus, Polio and Haemophilus Influentiae type B vaccines. CONCLUSIONS: This study has a high epidemiological power as it is based on information on adverse events having occurred in over one billion people. It suffers from lack of rigorous case verification due to the weakness intrinsic to the surveillance databases used. At variance with previous reports on a prevalence of ADEM in childhood we demonstrate that it may occur at any age when post vaccination. This study also shows that the diminishing trend in post vaccine ADEM reporting related to Diphtheria, Pertussis, Tetanus, Polio and Haemophilus Influentiae type B and human papilloma virus vaccine groups is most likely not [corrected] due to a decline in vaccine coverage indicative of a reduced attention to this adverse drug reaction.

  20. Acute Disseminated Encephalomyelitis Onset: Evaluation Based on Vaccine Adverse Events Reporting Systems

    Science.gov (United States)

    Perrone, Valentina; Pozzi, Marco; Antoniazzi, Stefania; Clementi, Emilio; Radice, Sonia

    2013-01-01

    Objective To evaluate epidemiological features of post vaccine acute disseminated encephalomyelitis (ADEM) by considering data from different pharmacovigilance surveillance systems. Methods The Vaccine Adverse Event Reporting System (VAERS) database and the EudraVigilance post-authorisation module (EVPM) were searched to identify post vaccine ADEM cases. Epidemiological features including sex and related vaccines were analysed. Results We retrieved 205 and 236 ADEM cases from the EVPM and VAERS databases, respectively, of which 404 were considered for epidemiological analysis following verification and causality assessment. Half of the patients had less than 18 years and with a slight male predominance. The time interval from vaccination to ADEM onset was 2-30 days in 61% of the cases. Vaccine against seasonal flu and human papilloma virus vaccine were those most frequently associated with ADEM, accounting for almost 30% of the total cases. Mean number of reports per year between 2005 and 2012 in VAERS database was 40±21.7, decreasing after 2010 mainly because of a reduction of reports associated with human papilloma virus and Diphtheria, Pertussis, Tetanus, Polio and Haemophilus Influentiae type B vaccines. Conclusions This study has a high epidemiological power as it is based on information on adverse events having occurred in over one billion people. It suffers from lack of rigorous case verification due to the weakness intrinsic to the surveillance databases used. At variance with previous reports on a prevalence of ADEM in childhood we demonstrate that it may occur at any age when post vaccination. This study also shows that the diminishing trend in post vaccine ADEM reporting related to Diphtheria, Pertussis, Tetanus, Polio and Haemophilus Influentiae type B and human papilloma virus vaccine groups is most likely due to a decline in vaccine coverage indicative of a reduced attention to this adverse drug reaction. PMID:24147076

  1. Adverse Drug Reactions in a Complementary Medicine Hospital: A Prospective, Intensified Surveillance Study

    Directory of Open Access Journals (Sweden)

    M. Süsskind

    2012-01-01

    Full Text Available Background. Anthroposophic medicine is one of the widely used approaches of complementary and alternative medicine. However, few prospective studies have generated safety data on its use. Objectives. We aimed to assess adverse drug reactions (ADRs caused by anthroposophical medicines (AMEDs in the anthroposophical Community Hospital Havelhoehe, GERMANY. Study Design and Methods. Between May and November 2007, patients of six medical wards were prospectively assessed for ADRs. Suspected ADRs occurring during hospitalization were documented and classified in terms of organ manifestation (WHO SOC-code, causality (according to the Uppsala Monitoring Centre WHO criteria, and severity. Only those ADRs with a severity of grade 2 and higher according to the CTCAE classification system are described here. Results. Of the 3,813 patients hospitalized, 174 patients (4.6% experienced 211 ADRs (CTCAE grade 2/3 n=191, 90.5%, CTCAE grade 4/5 n=20, 9.5% of which 57 ADRs (27.0% were serious. The median age of patients with ADRs (62.1% females was 72.0 (IQR: 61.0; 80.0. Six patients (0.2% experienced six ADRs (2.8% of ADRs caused by eight suspected AMEDs, all of which were mild reactions (grade 2. Conclusion. Our data show that ADRs caused by AMEDs occur rarely and are limited to mild symptoms.

  2. Severe cutaneous adverse drug reactions:a review on epidemiology,etiology,clinical manifestation and pathogenesis

    Institute of Scientific and Technical Information of China (English)

    Tomy Martin; LI Hui

    2008-01-01

    Purpose To review the current progress in epidemiology, etiology, clinical manifestation, and pathophysiology of severe cutaneous adverse drug reactions(SCADRs). Data sources Data were acquired by using Blackwell-Synergy, PubMed, original articles published in the main Chinese journals and related medical textbooks materials. Study-selection and date extraction Throughout the literature review 49 articles were selected. Results SCADRs cases are rare, however, the implication is life threatening with significant mortatity rates. Epidemiology studies have shown various incidences from different regions, gender, age, race and concurrent illness. There are typical signs and symptoms for each type of SCADRs, but this is not always so. Drugs associated with inducing SCADRs are anticonvulsants, antibiotics, NSAIDs and antirheumatic drugs. In some countries, especially in Asia, traditional drugs are offen the cause of SCADRs. Genetic polymorphisms and viral infections are predisposition factors of SCADRs. Patients with certain genetic alleles and underlying diseases are vulnerable to SCADRs. The exact pathogenesis of SCADRs is not well defined. Nonetheless, recent study showed that reactive metabolites and immunological processes have a significant role in SCADRs. Conclusions The different SCADRs reactions are attributed by different intrinsic factors, such as genetic polymorphisms, gender, age and race as well as extrinsic factors, such as underlying diseases. Different regions and culprit drugs also play a role in the various types of SCADRs.

  3. 基于 HIS 的药品不良反应快速上报与智能搜索系统研究与应用%Research and Application of Adverse Drug Reaction Rapid Reporting and Intelligent Searching System Based on HIS

    Institute of Scientific and Technical Information of China (English)

    邓剑雄; 王玲; 陈文戈; 舒婷; 张业象

    2015-01-01

    solved under reporting, misinformation, delay reporting and other issues of adverse drug reactions, achieved rapid reporting and intelligent searching functions, improved the hospital's ADR reporting rate and the reporter's initiative, and let the adverse drug reaction monitoring mode turn from the traditional"passive" to the "active". Conclusion The ADR rapid reporting and intelligent searching system effectively enhances the capacity of drug post-marketing surveillance, and greatly improves the rational drug use in medical institutions, and it is of significant importance to strengthen drug safety monitoring and evaluation in our country.

  4. Atopic diseases: Risk factor in developing adverse reaction to intravenous N-Acetylcysteine

    Directory of Open Access Journals (Sweden)

    F Gheshlaghi

    2006-05-01

    Full Text Available Background: N-acetylcysteine (NAC is the choice treatment for acetaminophen overdose. The main side effect of intravenous NAC therapy is anaphylaxis or anaphylactoid reactions. We investigated the prevalence of anaphylactoid or anaphylaxis reactions to IV-NAC therapy in acetaminophen poisoned patients with atopic disease. Methods: A case series antrograde and descriptive–analytic study was done on acetaminophen poisoned patients who treated with IV-NAC from September 2003 to September 2004 in Isfahan, Iran. Results: Of 173 infused IV-NAC patients, 77 patients (44.5% developed an anaphylactoid reaction. Its side effects was nausea and vomiting (n=49, 63.15%, flashing (n=23, 30.26%, bronchospasm (n=20, 26.31%, vertigo (n=18, 23.68%, skin rash (n=25, 32.36% and hypotension (n=12, 15.75%. Also, 71 patients (41% had history of atopic disease. Atopic diseases were asthma (n=12, 6.9%, atopic dermatitis (n=7, 4%, allergic rhinitis (n=5, 2.8% and allergic conjunctivitis (n=1, 0.5%. Among 71 atopic patients, 59 patients (83.13 % developed side effects to NAC. There was a relation between previous history of atopic disease and anaphylactoid reaction to NAC. Conclusions: We report substantially higher incidence of anaphylactoid reactions to IV-NAC than previous studies. Different atopic diseases must be considered as a risk factor in the development of side effects to IV-NAC-therapy. Keywords: Poisoning, Acetaminophen, Anaphylactoid reaction, N-acetylcysteine, Atopic disease

  5. An intensive monitoring of adverse drug reaction in indoor patients of medicine department at tertiary care teaching hospital

    OpenAIRE

    Nishita H. Darji; Shilpa Jadav; Chintan Doshi; Rutvij Hedamba; Rusva Mistry; Hiren Trivedi

    2016-01-01

    Background: Use of drugs itself may result into illness and death due to their adverse effects. In India 10-20% of inpatients developed adverse drug reactions. Most of these problems can be overcome by undertaking hospital based intensive monitoring. Objective of this study was to estimate the incidence and document the spectrum of ADRs in studied patients in terms of causality, severity, frequency, type and preventability. A prospective, observational, single centre study conducted among the...

  6. The Effect of Prophylactic Antipyretic Administration on Post-Vaccination Adverse Reactions and Antibody Response in Children: A Systematic Review

    OpenAIRE

    Rashmi Ranjan Das; Inusha Panigrahi; Sushree Samiksha Naik

    2014-01-01

    Background Prophylactic antipyretic administration decreases the post-vaccination adverse reactions. Recent study finds that they may also decrease the antibody responses to several vaccine antigens. This systematic review aimed to assess the evidence for a relationship between prophylactic antipyretic administration, post-vaccination adverse events, and antibody response in children. Methods A systematic search of major databases including MEDLINE and EMBASE was carried out till March 2014. ...

  7. 莫西沙星引起不良反应及分析%Adverse reaction and analyse the causes of Moxifloxacin

    Institute of Scientific and Technical Information of China (English)

    罗耀群

    2013-01-01

    Objective To summarize analysis of adverse reactions caused by moxifloxacin, to guide the rational use of clinical. Methods The domestic literature in recent years, the reported adverse reactions of moxifloxacin, summary, analysis and summary. Results The main adverse reactions of gastrointestinal system, central nervous system, cardiovascular system, etc;The elderly are adverse reactions of high-risk groups;Dosage has no significant gender differences, injected more than the oral medicine. Conclusion Moxifloxacin is the fourth generation of new fluoroquinolone antibiotic, by a large number of applications in recent years, adverse reaction is increasingly outstanding, should strengthen the management and reasonable use.%目的总结分析莫西沙星引起的不良反应,以指导临床合理使用。方法查阅近年来国内文献,对报道莫西沙星的不良反应,进行总结、分析、汇总。结果不良反应主要表现为胃肠道系统、心血管系统等;老年人是发生不良反应的高危人群;无明显的的性别差异,给药途径为注射给药多于口服给药。结论莫西沙星是第四代新型氟喹诺酮类抗菌药物,近年来被大量的应用,不良反应日益突出,应加强管理合理使用。

  8. Hospitalization in older patients due to adverse drug reactions – the need for a prediction tool

    Directory of Open Access Journals (Sweden)

    Parameswaran Nair N

    2016-05-01

    Full Text Available Nibu Parameswaran Nair, Leanne Chalmers, Gregory M Peterson, Bonnie J Bereznicki, Ronald L Castelino, Luke R Bereznicki Division of Pharmacy, School of Medicine, Faculty of Health, University of Tasmania, Hobart, TAS, Australia Abstract: Adverse drug reactions (ADRs represent a major burden on society, resulting in significant morbidity, mortality, and health care costs. Older patients living in the community are particularly susceptible to ADRs, and are at an increased risk of ADR-related hospitalization. This review summarizes the available evidence on ADR-related hospital admission in older patients living in the community, with a particular focus on risk factors for ADRs leading to hospital admission and the need for a prediction tool for risk of ADR-related hospitalization in these individuals. The reported proportion of hospital admissions due to ADRs has ranged from 6% to 12% of all admissions in older patients. The main risk factors or predictors for ADR-related admissions were advanced age, polypharmacy, comorbidity, and potentially inappropriate medications. There is a clear need to design intervention strategies to prevent ADR-related hospitalization in older patients. To ensure the cost-effectiveness of such strategies, it would be necessary to target them to those older individuals who are at highest risk of ADR-related hospitalization. Currently, there are no validated tools to assess the risk of ADRs in primary care. There is a clear need to investigate the utility of tools to identify high-risk patients to target appropriate interventions toward prevention of ADR-related hospital admissions. Keywords: adverse drug reactions, hospital admission, prediction, older patients, primary care, risk factors

  9. Analysis of Stevens-Johnson syndrome and toxic epidermal necrolysis using the Japanese Adverse Drug Event Report database

    OpenAIRE

    Abe, Junko; Umetsu, Ryogo; Mataki, Kanako; Kato, Yamato; Ueda, Natsumi; NAKAYAMA, Yoko; Hane, Yuuki; Matsui, Toshinobu; Hatahira, Haruna; Sasaoka, Sayaka; Motooka, Yumi; Hara, Hideaki; Kato, Zenichiro; Kinosada, Yasutomi; Inagaki, Naoki

    2016-01-01

    Background Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are severe cutaneous adverse reactions associated with fatal disorders. Although many causes of SJS/TEN have been proposed, the time-to-onset for SJS/TEN and the relationship between aging and SJS/TEN are still not clear. Therefore, the aim of this study was to determine the relationship between aging and SJS/TEN using the Japanese Adverse Drug Event Report (JADER) database and analyze the time-to-onset profile of ...

  10. Reporting of adverse events for marketed drugs: Need for strengthening safety database

    Science.gov (United States)

    Apte, Aditi Anand

    2016-01-01

    Pharmacovigilance is an evolving discipline in the Indian context. However, there is limited regulatory guidance for adverse event reporting outside the purview of clinical trials. There are number of deficiencies in the framework for adverse event reporting from the perspective of pharma industry, health-care professional and general public due to which adverse events for marketed drugs are highly underreported. This article discusses the need to strengthen national safety database by promoting and mandating reporting of adverse events by all the stakeholders. PMID:27453826

  11. Dystonia as acute adverse reaction to cough suppressant in a 3-year-old girl.

    Science.gov (United States)

    Polizzi, A; Incorpora, G; Ruggieri, M

    2001-01-01

    Cough suppressant preparations containing mixtures of dextromethorphan or codeine with antihistamines, decongestants (sympathomimetic), expectorants and antipyretics with either sedative or anticholinergic activity have been associated with dystonic reactions in children. We report on a 3-year-old girl who presented with episodic stiffness and abnormal posturing with rigidity after arbitrary maternal administration of a mixture of methylcodeine and extract from Hedera plant. PMID:11587381

  12. Trends of adverse drug reactions related-hospitalizations in Spain (2001-2006

    Directory of Open Access Journals (Sweden)

    de Miguel Gil

    2010-10-01

    Full Text Available Abstract Background Adverse drug reactions (ADR are a substantial cause of hospital admissions. We conducted a nationwide study to estimate the burden of hospital admissions for ADRs in Spain during a six-year period (2001-2006 along with the associated total health cost. Methods Data were obtained from the national surveillance system for hospital data (Minimum Basic Data Set maintained by the Ministry of Health and Consumer Affairs, and covering more than 95% of Spanish hospitals. From these admissions we selected all hospitalization that were code as drug-related (ICD-9-CM codes E, but intended forms of overdoses, errors in administration and therapeutics failure were excluded. The average number of hospitalizations per year, annual incidence of hospital admissions, average length of stay in the hospital, and case-fatality rate, were calculated. Results During the 2001-2006 periods, the total number of hospitalized patients with ADR diagnosis was 350,835 subjects, 1.69% of all acute hospital admissions in Spain. The estimated incidence of admissions due to ADR decreased during the period 2001-2006 (p Conclusions Approximately 1.69% of all acute hospital admissions were associated with ADRs. The rates were much higher for elderly patients. The total cost of ADR-related hospitalization to the Spanish health system is high and has increased between 2001 and 2006. ADRs are an important cause of admission, resulting in considerable use of national health system beds and a significant number of deaths.

  13. Adverse reactions to tattoos: a study from the hilly region in northern India

    Directory of Open Access Journals (Sweden)

    Subhash Kashyap

    2016-07-01

    Results: A total of thirty-three cases (19 male and 14 females with complications to tattoos were registered over the period of one year. Thirty patients had their tattoo from an amateur while only three had from a professional tattooist. Twenty one (63.6% had acute complications and twelve (36.3% had chronic complications. Histpathological examination (HPE was done in ten of these cases and two refused biopsy. The findings were suggestive of lupus vulgaris (LV and foreign body granuloma (FBG in three each; chronic granulomatous changes in two, and spongiotic dermatitis (SD, and lichen planus hypertrophicus (LPH in one case each. Conclusions: Tattooing being largely unregulated has led to variability in contents of tattoo solution and inadequate sterilization during the procedure. This combined with lack of awareness, increases the chances of various adverse reactions. So it is extremely important to strictly regularize the tattoo practice and to increase awareness about tattoo complications among consumers, tattoo artists and dermatologists. [Int J Res Med Sci 2016; 4(7.000: 2556-2563

  14. Analysis and management of the adverse reactions in CO2-angiography

    International Nuclear Information System (INIS)

    Objective: To analyze the prevalence of the adverse drug reactions (ADRs) in CO2-angiography and to put forward the management. Methods: Two-hundred and nine CO2-angiography examinations were done in 132 patients. Vital signs, electrocardiogram, and oxygen saturation were monitored. Patients were questioned about discomfort during the examination. The scale from 0 to 4 was adapted to evaluate the extension of discomfort (0 = none; 4 = severe discomfort or complication). Results: ADRs, including pain and burn feeling in abdomen, pain with numbness in lower extremity, nausea, vomiting, palpitation, and dyspnea etc. were presented in 34 cases (25.8%). The average grade of patients with ADRs during CO2-angiography was 1.76 +- 0.91 (x-bar +- s). The average grade of the 132 patients was 0.45. ADRs in 25 patients (73.5%) were temporary, and relieved without treatment. The other 9 patients (26.5%) with ADRs alleviated rapidly after heteropathy. No severe complication was found in all patients. Conclusion: CO2 is a safe contrast medium in angiography. Although ADRs was found in part of patients, most of them can relieve without management and a minority alleviated by heteropathy

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

    Directory of Open Access Journals (Sweden)

    Alpa Pragnesh Gor

    2011-01-01

    Full Text Available 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 the ADRs. Results: 26% of the 100 patients developed ADR due to NSAIDs. There was not much of a difference in the number of the ADRs in relation to the gender. Diclofenac was the highest prescribed drug (65 patients, followed by paracetamol (12, nimesulide (10, ibuprofen (6, piroxicam (5 and Etoricoxib (2. Diclofenac accounted for the maximum number (73% of ADRs, followed by nimesulide (16%, paracetamol (7%, and Etoricoxib (4%. Conclusion: Pharmacovigilance improves recognition of ADRs by the medical students. It allows the treating physician to identify the ADR associated with drugs, in particular, with the ones considered relatively safe and with those commonly prescribed by the medical and non-health professionals.

  16. A Pharmacovigilance Approach for Post-Marketing in Japan Using the Japanese Adverse Drug Event Report (JADER Database and Association Analysis.

    Directory of Open Access Journals (Sweden)

    Masakazu Fujiwara

    Full Text Available Rapid dissemination of information regarding adverse drug reactions is a key aspect for improving pharmacovigilance. There is a possibility that unknown adverse drug reactions will become apparent through post-marketing administration. Currently, although there have been studies evaluating the relationships between a drug and adverse drug reactions using the JADER database which collects reported spontaneous adverse drug reactions, an efficient approach to assess the association between adverse drug reactions of drugs with the same indications as well as the influence of demographics (e.g. gender has not been proposed.We utilized the REAC and DEMO tables from the May 2015 version of JADER for patients taking antidepressant drugs (SSRI, SNRI, and NaSSA. We evaluated the associations using association analyses with an apriori algorithm. Support, confidence, lift, and conviction were used as indicators for associations. The highest score in adverse drug reactions for SSRI was obtained for "aspartate aminotransferase increased", "alanine aminotransferase increased", with values of 0.0059, 0.93, 135.5, and 13.9 for support, confidence, lift and conviction, respectively. For SNRI, "international normalized ratio increased", "drug interaction" were observed with 0.0064, 1.00, 71.9, and NA. For NaSSA, "anxiety", "irritability" were observed with 0.0058, 0.80, 49.9, and 4.9. For female taking SSRI, the highest support scores were observed in "twenties", "suicide attempt", whereas "thirties", "neuroleptic malignant syndrome" were observed for male. Second, for SNRI, "eighties", "inappropriate antidiuretic hormone secretion" were observed for female, whereas "interstitial lung disease" and "hepatitis fulminant" were for male. Finally, for NaSSA, "suicidal ideation" was for female, and "rhabdomyolysis" was for male.Different combinations of adverse drug reactions were noted between the antidepressants. In addition, the reported adverse drug reactions

  17. A Pharmacovigilance Approach for Post-Marketing in Japan Using the Japanese Adverse Drug Event Report (JADER) Database and Association Analysis

    Science.gov (United States)

    Fujiwara, Masakazu; Kawasaki, Yohei; Yamada, Hiroshi

    2016-01-01

    Background Rapid dissemination of information regarding adverse drug reactions is a key aspect for improving pharmacovigilance. There is a possibility that unknown adverse drug reactions will become apparent through post-marketing administration. Currently, although there have been studies evaluating the relationships between a drug and adverse drug reactions using the JADER database which collects reported spontaneous adverse drug reactions, an efficient approach to assess the association between adverse drug reactions of drugs with the same indications as well as the influence of demographics (e.g. gender) has not been proposed. Methods and Findings We utilized the REAC and DEMO tables from the May 2015 version of JADER for patients taking antidepressant drugs (SSRI, SNRI, and NaSSA). We evaluated the associations using association analyses with an apriori algorithm. Support, confidence, lift, and conviction were used as indicators for associations. The highest score in adverse drug reactions for SSRI was obtained for "aspartate aminotransferase increased", "alanine aminotransferase increased", with values of 0.0059, 0.93, 135.5, and 13.9 for support, confidence, lift and conviction, respectively. For SNRI, "international normalized ratio increased", "drug interaction" were observed with 0.0064, 1.00, 71.9, and NA. For NaSSA, "anxiety", "irritability" were observed with 0.0058, 0.80, 49.9, and 4.9. For female taking SSRI, the highest support scores were observed in "twenties", "suicide attempt", whereas "thirties", "neuroleptic malignant syndrome" were observed for male. Second, for SNRI, "eighties", "inappropriate antidiuretic hormone secretion" were observed for female, whereas "interstitial lung disease" and "hepatitis fulminant" were for male. Finally, for NaSSA, "suicidal ideation" was for female, and "rhabdomyolysis" was for male. Conclusions Different combinations of adverse drug reactions were noted between the antidepressants. In addition, the reported

  18. 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...... on the development of related European Directives, some technical aspects of dimethyl sulfoxide and the sequential stages of preservation and administration....

  19. [Diagnostic and therapeutic procedure for two popular but quite distinct adverse reactions to food - fructose malabsorption and histamine intolerance].

    Science.gov (United States)

    Reese, I

    2012-04-01

    Claiming to suffer from adverse food reactions is popular. In contrast to the classical food allergy, there are some pathomechanisms which are evidently dose-dependent. Thus the procedure in diagnosis and therapy must undoubtedly differ from the practice when food allergy is suspected or proven. Nevertheless many patients suffering from dose-dependent adverse reactions to food are given strict elimination diets, which is neither necessary nor helpful and decreases their quality of life broadly. This holds especially true for fructose malabsorption and histamine intolerance. For the latter, the term adverse reaction to ingested histamine is preferred, because histamine intolerance implies that symptoms are caused entirely by an enzyme defect. Why this is not very likely to be the only reason is discussed in this article. Both adverse reactions require an individual approach especially with regard to nutrition therapy. Therefore the task of diagnosis should be to establish an individual profile of tolerated and not tolerated foods taking into account that tolerance can greatly vary by meal composition, frequency and individual triggering factors. In view of this, therapeutic recommendations should not be based on the absolute quantities of the eliciting substance to be eliminated but on a feasible transfer into daily life. Thereby food restriction can be minimized and a high quality of life will be maintained. PMID:22477662

  20. 血塞通注射液不良反应分析%Analysis of Xuesaitong injection adverse reactions

    Institute of Scientific and Technical Information of China (English)

    石二霞

    2015-01-01

    目的:探讨血塞通注射剂不良反应发生的原因及相关因素,促进临床合理应用。方法:通过对2例应用血塞通注射剂后发生不良反应案例进行分析,总结出现不良反应的原因及避免不良反应发生措施。结果:临床使用血塞通注射液应严格按照说明书的适应症,选择适当的溶媒,密切观察用药过程,将药物不良反应发生率降至最低,促进临床合理用药。%Objective To investigate the occurrence of adverse reaction of Xuesaitong injection and its related factors,in order to promote the rational use of traditional Chinese medicine injection. Methods Through the correlation analysis on 2 cases of adverse reactions induced by Xuesaitong injection after application case,summarized the reasons of adverse reactions and corresponding measures. Results The clinical use of Xuesaitong injection should be strictly in accordance with the instructions,reduce the incidence of adverse drug reactions to a minimum and improve public safety.

  1. The Logic of Surveillance Guidelines: An Analysis of Vaccine Adverse Event Reports from an Ontological Perspective

    OpenAIRE

    Courtot, Mélanie; Brinkman, Ryan R; Ruttenberg, Alan

    2014-01-01

    Background When increased rates of adverse events following immunization are detected, regulatory action can be taken by public health agencies. However to be interpreted reports of adverse events must be encoded in a consistent way. Regulatory agencies rely on guidelines to help determine the diagnosis of the adverse events. Manual application of these guidelines is expensive, time consuming, and open to logical errors. Representing these guidelines in a format amenable to automated processi...

  2. The Logic of Surveillance Guidelines: An Analysis of Vaccine Adverse Event Reports from an Ontological Perspective

    OpenAIRE

    Mélanie Courtot; Brinkman, Ryan R.; Alan Ruttenberg

    2014-01-01

    BACKGROUND: When increased rates of adverse events following immunization are detected, regulatory action can be taken by public health agencies. However to be interpreted reports of adverse events must be encoded in a consistent way. Regulatory agencies rely on guidelines to help determine the diagnosis of the adverse events. Manual application of these guidelines is expensive, time consuming, and open to logical errors. Representing these guidelines in a format amenable to automated process...

  3. Polypharmacy and adverse drug reactions in Japanese elderly taking antihypertensives: a retrospective database study

    Directory of Open Access Journals (Sweden)

    Sato I

    2013-06-01

    Full Text Available Izumi Sato,1 Manabu Akazawa21Department of Epidemiology and Statistics, Graduate School of Medicine, The University of Tokyo Tokyo, Japan; 2Department of Public Health and Epidemiology, Meiji Pharmaceutical University, Tokyo, JapanBackground: The concomitant use of multiple medications by elderly patients with hypertension is a relatively common and growing phenomenon in Japan. This has been attributed to several factors, including treatment guidelines recommending prescription of multiple medications and a continuing increase in the elderly population with multiple comorbidities.Objective: This study was aimed at investigating the association between polypharmacy, defined as the concomitant use of five or more medications, and risk of adverse drug reaction (ADR in elderly Japanese hypertensive patients to examine the hypothesis that risk of ADR increases with the administration of an increasing number of co-medications.Methods: Using a retrospective cohort design, the data regarding all hypertensive patients aged 65 years or older were extracted from the Risk/Benefit Assessment of Drugs – Analysis and Response Council antihypertensive medication database. The data were reviewed for classification of patients into one of three groups according to drug use at the initiation of therapy – a monotherapy group composed of patients who had taken the investigated drug only, a co-medication group composed of patients who had taken the investigated drug and a maximum of three other medications, and a polypharmacy group composed of patients who had taken the investigated drug and four or more other medications – and determination of the number of ADR events experienced. Estimated rate ratios (RRs and 95% confidence intervals (CIs were calculated using a Poisson regression model adjusted for drug category and patient age and sex. Various sensitivity analyses were performed to confirm the robustness of the study findings.Results: Of 61,661 elderly

  4. Post-marketing surveillance of the safety profile of iodixanol in the outpatient CT setting. A prospective, multicenter, observational study of patient risk factors, adverse reactions and preventive measures in 9953 patients

    International Nuclear Information System (INIS)

    Non-interventional study in outpatient, contrast-enhanced CT: 1. to determine the extent of preventive measures for risk reduction of adverse drug reactions after contrast-enhanced CT examinations. 2. to prospectively determine the incidence and severity of adverse drug reactions occurring after administration of the iso-osmolar contrast medium iodixanol. 3. to determine a possible influence of preventive measures on the incidence/severity of adverse drug reactions. Evaluable documentation was provided for 9953 patients from 66 radiology centers across Germany. Patient characteristics, aspects of iodixanol administration, and adverse events with an at least 'possible' relationship were documented on a standardized case report form (CRF) and were evaluated up to seven days after contrast medium administration. About 55.5% of patients showed one or more risk factors (e.g. impaired renal function 4.4%, diabetes mellitus 8.5%, hypertension 20.6%). One third of the sites did not implement any preventive measures. Patients with a known risk for an allergy-like reaction were more likely to receive pharmacologic preventive treatment (0.5-50.5%). Oral hydration was the main preventive measure in patients with renal risk factors (<8%) followed by intravenous hydration (1%). Adverse drug reactions, mainly hypersensitivity reactions, occurred in 77 patients (0.74%), but were classified as serious in only 3 patients (0.03%). No statistically significant correlation between risk factors, preventive measures, and adverse reactions could be found. The use of preventive measures for CT examinations in this outpatient setting was generally low with risk patients being pre-medicated more often, depending on their history. In the routine outpatient setting, iso-osmolar iodixanol was very well tolerated in almost 10 000 patients undergoing diagnostic CT. The rate of acute and delayed adverse reactions was low. No correlation could be found between risk factors, preventive measures and

  5. Post-marketing surveillance of the safety profile of iodixanol in the outpatient CT setting. A prospective, multicenter, observational study of patient risk factors, adverse reactions and preventive measures in 9953 patients

    Energy Technology Data Exchange (ETDEWEB)

    Mueller, Frank Hugo Heinz [Radiology and Nuclear Medicine Center, Ludwigshafen (Germany)

    2014-11-15

    Non-interventional study in outpatient, contrast-enhanced CT: 1. to determine the extent of preventive measures for risk reduction of adverse drug reactions after contrast-enhanced CT examinations. 2. to prospectively determine the incidence and severity of adverse drug reactions occurring after administration of the iso-osmolar contrast medium iodixanol. 3. to determine a possible influence of preventive measures on the incidence/severity of adverse drug reactions. Evaluable documentation was provided for 9953 patients from 66 radiology centers across Germany. Patient characteristics, aspects of iodixanol administration, and adverse events with an at least 'possible' relationship were documented on a standardized case report form (CRF) and were evaluated up to seven days after contrast medium administration. About 55.5% of patients showed one or more risk factors (e.g. impaired renal function 4.4%, diabetes mellitus 8.5%, hypertension 20.6%). One third of the sites did not implement any preventive measures. Patients with a known risk for an allergy-like reaction were more likely to receive pharmacologic preventive treatment (0.5-50.5%). Oral hydration was the main preventive measure in patients with renal risk factors (<8%) followed by intravenous hydration (1%). Adverse drug reactions, mainly hypersensitivity reactions, occurred in 77 patients (0.74%), but were classified as serious in only 3 patients (0.03%). No statistically significant correlation between risk factors, preventive measures, and adverse reactions could be found. The use of preventive measures for CT examinations in this outpatient setting was generally low with risk patients being pre-medicated more often, depending on their history. In the routine outpatient setting, iso-osmolar iodixanol was very well tolerated in almost 10 000 patients undergoing diagnostic CT. The rate of acute and delayed adverse reactions was low. No correlation could be found between risk factors, preventive

  6. The Clinical Manifestations, Treatment Efficacy and Adverse Drug Reactions in 62 Iranian Child with Wilson Disease

    Directory of Open Access Journals (Sweden)

    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.

  7. Harvesting candidate genes responsible for serious adverse drug reactions from a chemical-protein interactome.

    Directory of Open Access Journals (Sweden)

    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.

  8. Development of an Adverse Drug Reaction Risk Assessment Score among Hospitalized Patients with Chronic Kidney Disease

    Science.gov (United States)

    Saheb Sharif-Askari, Fatemeh; Syed Sulaiman, Syed Azhar; Saheb Sharif-Askari, Narjes; Al Sayed Hussain, Ali

    2014-01-01

    Background Adverse drug reactions (ADRs) represent a major burden on the healthcare system. Chronic kidney disease (CKD) patients are particularly vulnerable to ADRs because they are usually on multiple drug regimens, have multiple comorbidities, and because of alteration in their pharmacokinetics and pharmacodynamic parameters. Therefore, one step towards reducing this burden is to identify patients who are at increased risk of an ADR. Objective To develop a method of identifying CKD patients who are at increased risk for experiencing ADRs during hospitalisation. Materials and Methods Factors associated with ADRs were identified by using demographic, clinical and laboratory variables of patients with CKD stages 3 to 5 (estimated glomerular filtration rate, 10–59 ml/min/1.73 m2) who were admitted between January 1, 2012, and December 31, 2012, to the renal unit of Dubai Hospital. An ADR risk score was developed by constructing a series of logistic regression models. The overall model performance for sequential models was evaluated using Akaike Information Criterion for goodness of fit. Odd ratios of the variables retained in the best model were used to compute the risk scores. Results Of 512 patients (mean [SD] age, 60 [16] years), 62 (12.1%) experienced an ADR during their hospitalisation. An ADR risk score included age 65 years or more, female sex, conservatively managed end-stage renal disease, vascular disease, serum level of C-reactive protein more than 10 mg/L, serum level of albumin less than 3.5 g/dL, and the use of 8 medications or more during hospitalization. The C statistic, which assesses the ability of the risk score to predict ADRs, was 0.838; 95% CI, 0.784–0.892). Conclusion A score using routinely available patient data can be used to identify CKD patients who are at increased risk of ADRs. PMID:24755778

  9. Treatments that generate higher number of adverse drug reactions and their symptoms

    Directory of Open Access Journals (Sweden)

    Lucía Fernández-López

    2015-12-01

    Full Text Available Objectives: Adverse drug reactions (ADRs are an important cause of morbidity and mortality worldwide and generate high health costs. Therefore, the aims of this study were to determine the treatments which produce more ADRs in general population and the main symptoms they generate. Methods: An observational, cross-sectional study consisting in performing a self-rated questionnaire was carried out. 510 patients were asked about the treatments, illnesses and ADRs, they had suffered from. Results: 26.7% of patients had suffered from some ADR. Classifying patients according to the type of prescribed treatment and studying the number of ADR that they had, we obtained significant differences (p ≤ 0.05 for treatments against arthrosis, anemia and nervous disorders (anxiety, depression, insomnia. Moreover, determining absolute frequencies of these ADRs appearance in each treatment, higher frequencies were again for drugs against arthrosis (22.6% of patients treated for arthrosis suffered some ADR, anemia (14.28%, nerve disorders (13.44% and also asthma (16%. Regarding the symptoms produced by ADRs, the most frequent were gastrointestinal (60% of patients who suffered an ADR, had gastrointestinal symptoms and nervous alterations (dizziness, headache, sleep disturbances etc (24.6%. Conclusion: Therapeutic groups which produce more commonly ADRs are those for arthrosis, anemia, nervous disorders and asthma. In addition, symptoms which are generated more frequently are gastrointestinal and nervous problems. This is in accordance with the usual side effects of mentioned treatments. Health professionals should be informed about it, so that they would be more alert about a possible emergence of an ADR in these treatments. They also could provide enough information to empower patients and thus, they probably could detect ADR events. This would facilitate ADR detection and would avoid serious consequences generated to both patients' health and health economics.

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

    OpenAIRE

    Richa; V R Tandon; S Sharma; V Khajuria; Mahajan, V.; Z Gillani

    2015-01-01

    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 intraveno...

  11. Pharmacovigilance Analysis of Serious Adverse Events Reported for Biologic Response Modifiers Used as Prophylaxis against Transplant Rejection: a Real-World Postmarketing Experience from the US FDA Adverse Event Reporting System (FAERS)

    Science.gov (United States)

    Ali, A. K.

    2013-01-01

    Background: Immunosuppression by biologic response modifiers (BRM) is a crucial component for successful organ transplantation. In addition to their variable effectiveness in the prevention of organ rejection, these medications have safety concerns that complicate therapeutic outcomes in organ transplant patients. Objective: This study aims at identifying and characterizing safety signals of serious adverse events associated with exposure to BRM among organ transplant patients in a real-world environment. Methods: The FDA Adverse Event Reporting System was utilized to apply a pharmacovigilance disproportionality analysis to indentify serious adverse events. Associations between drugs and events were measured by empirical Bayes geometric mean (EBGM) and the corresponding 95% confidence intervals (EB05–EB95). Associations with EBGM≥2 were considered significant safety signals. Results: From 1997 to 2012, a total of 12,151 serious adverse event reports for BRM were reported; 15.6% of them (n=1,711) met the safety signal threshold of EB05>1, and 11.6% of these signals (n=199) were significant (EBGM≥2). Sirolimus and mycophenolate accounted for the majority of all signals; antithymocyte immunoglobulin (ATI) and cyclosporine contributed to the majority of significant signals. The following significant signals were identified for ATI (reduced therapeutic response, pulmonary edema, hypotension, serum sickness, infusion-related reaction, and anaphylactic reaction); for azathioprine (alternaria infection, fungal skin infection, and lymphoproliferative disorder); for cyclosporine (neurotoxicity, graft vs. host disease, and thyroid cancer); for cyclophosphamide (disease progression); for daclizumab (cytomegalovirus infection); and for tacrolimus (coma and tremor). 33.6% of these events contributed to patient death (n=67); 6.5% were life-threatening (n=13); 32.1% lead to hospitalization (n=64); and 27.6% resulted in other serious outcomes (n=55). Conclusion: Utilization

  12. Adverse event reporting and developments in radiation biology after normal tissue injury: International Atomic Energy Agency consultation

    International Nuclear Information System (INIS)

    Purpose: Recent research has enhanced our understanding of radiation injury at the molecular-cellular and tissue levels; significant strides have occurred in standardization of adverse event reporting in clinical trials. In response, the International Atomic Energy Agency, through its Division of Human Health and its section for Applied Radiation Biology and Radiotherapy, organized a consultation meeting in Atlanta (October 2, 2004) to discuss developments in radiobiology, normal tissue reactions, and adverse event reporting. Methods and Materials: Representatives from cooperative groups of African Radiation Oncology Group, Curriculo Radioterapeutica Ibero Latino Americana, European Organization for Research and Treatment of Cancer, National Cancer Institute of Canada Clinical Trials Group, Radiation Therapy Oncology Group, and Trans-Tasman Radiation Oncology Group held the meeting discussion. Results: Representatives of major radiotherapy groups/organizations and prominent leaders in radiotherapy discussed current understanding of normal tissue radiobiologic effects, the design and implementation of future clinical and translational projects for normal tissue injury, and the standardization of adverse-event reporting worldwide. Conclusions: The consensus was to adopt NCI comprehensive adverse event reporting terminology and grading system (CTCAE v3.0) as the new standard for all cooperative group trials. Future plans included the implementation of coordinated research projects focusing on normal tissue biomarkers and data collection methods

  13. Reactions to adverse incidents in the health services on Twitter: a mixed methods study

    Directory of Open Access Journals (Sweden)

    Sarah Meaney

    2015-10-01

    Full Text Available 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, stimulated much public debate including debate online. Aim: Our study aimed to explore the Twitter status updates, and subsequent responses, relating to a number of perinatal deaths which occurred in a maternity unit with approximately 2,000 births per year. Method: As this study examined Twitter status updates in relation to reported perinatal death a mixed methods approach was adopted. Firstly, status updates in English were searched utilising the Twitter search function on its website. A search was undertaken on all public status updates from January 29th 2014 to March 31st 2014 relating to the perinatal deaths. Data were quantitatively analysed in order to assess the frequency of status updates, the demographic profiles of users and to ascertain the potential reach of the status updates. Secondly qualitative analysis was employed to generate themes from the content that twitter users shared publically. Results: From January 29th 2014 to March 31st 2014, 3,577 Twitter status updates from 1,276 profiles relating to the perinatal deaths were identified. Of these, 54.1% (n=1615 were tweets, 38.9% (n=1392 were retweets and 15.9% (n=570 were replies. Over one third of all updates (36.8%; n=1317 were from profiles which identified the user as either a media outlet or media personnel. One in 10 (11.8%; 424 status updates were by those who self-identified as a parent. Twitter was not utilised as a platform by any healthcare authority to release a statement in

  14. Identification of SNPs associated with susceptibility for development of adverse reactions to radiotherapy

    OpenAIRE

    Rosenstein, Barry S.

    2011-01-01

    Although cancer treatment with radiation can produce high cure rates, adverse effects often result from radiotherapy. These toxicities are manifested as damage to normal tissues and organs in the radiation field. In recognition of the substantial variation in the intrinsic response of individuals to radiation, an effort began approximately 10 years ago to discover the genetic markers, primarily SNPs, which are associated with susceptibility for the development of these adverse responses to ra...

  15. Adverse drug reactions to tocolytic treatment for preterm labour: Prospective cohort study

    OpenAIRE

    Heus, R.; Mol, B. W.; Erwich, J.J.H.M.; van Geijn, H.P.; Gyselaers, W.J.; Hanssens, M.; Harmark, L.; van Holsbeke, C.D.; Duvekot, J.J.; Schobben, F.F.A.M.; Wolf, Hans; Visser, G. H. A.

    2009-01-01

    textabstractObjective To evaluate the incidence of serious maternal complications after the use of various tocolytic drugs for the treatment of preterm labour in routine clinical situations. Design Prospective cohort study. Setting 28 hospitals in the Netherlands and Belgium. Participants 1920 consecutive women treated with tocolytics for threatened preterm labour. Main outcome measures Maternal adverse events (those suspected of being causally related to treatment were considered adverse dru...

  16. Patient-reported outcomes and the evolution of adverse event reporting in oncology.

    Science.gov (United States)

    Trotti, Andy; Colevas, A Dimitrios; Setser, Ann; Basch, Ethan

    2007-11-10

    Adverse event (AE) reporting in oncology has evolved from informal descriptions to a highly systematized process. The Common Terminology Criteria for Adverse Events (CTCAE) is the predominant system for describing the severity of AEs commonly encountered in oncology clinical trials. CTCAE clinical descriptors have been developed empirically during more than 30 years of use. The method of data collection is clinician based. Limitations of the CTC system include potential for incomplete reporting and limited guidance on data analysis and presentation methods. The Medical Dictionary for Regulatory Activities (MedDRA) is a comprehensive medical terminology system used for regulatory reporting and drug labeling. MedDRA does not provide for severity ranking of AEs. CTC-based data presentations are the primary method of AE data reporting used in scientific journals and oncology meetings. Patient-reported outcome instruments (PROs) cover the subjective domain of AEs. Exploratory work suggests PROs can be used with a high degree of patient engagement and compliance. Additional studies are needed to determine how PROs can be used to complement current AE reporting systems. Potential models for integrating PROs into AE reporting are described in this review. AE reporting methods will continue to evolve in response to changing therapies and growing interest in measuring the impact of cancer treatment on health status. Although integration of PROs into AE reporting may ultimately improve the comprehensiveness and quality of collected data, it may also increase the administrative burden and cost of conducting trials. Therefore, care must be used when developing health outcomes and safety data collection plans. PMID:17991931

  17. Large-scale survey of adverse reactions to canine non-rabies combined vaccines in Japan.

    Science.gov (United States)

    Miyaji, Kazuki; Suzuki, Aki; Shimakura, Hidekatsu; Takase, Yukari; Kiuchi, Akio; Fujimura, Masato; Kurita, Goro; Tsujimoto, Hajime; Sakaguchi, Masahiro

    2012-01-15

    Canine non-rabies combined vaccines are widely used to protect animals from infectious agents, and also play an important role in public health. We performed a large-scale survey to investigate vaccine-associated adverse events (VAAEs), including anaphylaxis, in Japan by distributing questionnaires on VAAEs to veterinary hospitals from April 1, 2006 through May 31, 2007. Valid responses were obtained for 57,300 vaccinated dogs at 573 animal hospitals; we obtained VAAEs information for last 100 vaccinated dogs in each veterinary hospital. We found that of the 57,300, 359 dogs showed VAAEs. Of the 359 dogs, death was observed in 1, anaphylaxis in 41, dermatological signs in 244, gastrointestinal signs in 160, and other signs in 106. Onset of VAAEs was mostly observed within 12h after vaccination (n=299, 83.3%). In this study, anaphylaxis events occurred within 60 min after vaccination, and about half of these events occurred within 5 min (n=19, 46.3%). Furthermore, where anaphylaxis was reported, additional information to support the diagnosis was obtained by reinvestigation. Our resurvey of dogs with anaphylaxis yielded responses on 31 dogs; 27 of these demonstrated collapse (87.1%), 24 demonstrated cyanosis (77.4%), and both signs occurred in 22 (71.0%). Higher rates of animal VAAEs, anaphylaxis, and death were found in Japan than in other countries. Further investigations, including survey studies, will be necessary to elucidate the interaction between death and vaccination and the risk factors for VAAEs, and thus develop safer vaccines. Moreover, it may also be necessary to continually update the data of VAAEs. PMID:22264736

  18. Development, implementation, and analysis of adverse drug reaction monitoring system in a rural tertiary care teaching hospital in Narketpally, Telangana

    OpenAIRE

    S.M. Shareef; C. D. M. Naidu; Shrinivas R. Raikar; Y. Venkata Rao; U. Devika

    2015-01-01

    Background: Adverse drug reactions (ADR) are the fourth leading cause of mortality and a great concern in therapeutics. Pharmacovigilance is more important in India as the health care system is inadequate with poor doctor-patient ratio, high incidence of self-medication, and presence of counterfeit drugs. The present study was conducted with the aim of analyzing the pattern of ADR occurring in a rural tertiary care hospital with a newly established pharmacovigilance center and to identify the...

  19. Identification of possible adverse drug reactions in clinical notes:the case of glucose-lowering medicines

    OpenAIRE

    Warrer, Pernille; Jensen, Peter Bjødstrup; Aagaard, Lise; Jensen, Lars Juhl; Brunak, Søren; Krag, Malene Hammer; Rossing, Peter; Almdal, Thomas; Andersen, Henrik Ullits; Hansen, Ebba Holme

    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 lowering medicines" (A10BD), "dipeptidyl peptidase-4 (DDP-4) inhibitors" (A10BH), and "other blood glucose lowering medicines" (A10BX). Specifically, we aimed to describe the potential of clinical notes ...

  20. Design of the Anti-tuberculosis Drugs induced Adverse Reactions in China National Tuberculosis Prevention and Control Scheme Study (ADACS)

    OpenAIRE

    He Ping; Yang Li; Chen Da; Wang Hong; Gao Wei; Zhu Li; Zhou Lin; Chen Yi; Tu,, Y.; Yuan Yan; Wang Xiao; Liu Fei; Hu Dai; Xia Yin; Li Xiao

    2010-01-01

    Abstract Background More than 1 million tuberculosis (TB) patients are receiving the standard anti-TB treatment provided by China National Tuberculosis Prevention and Control Scheme (CNTS) in China every year. Adverse reactions (ADRs) induced by anti-TB drugs could both do harm to patients and lead to anti-TB treatment failure. The ADACS aimed to explore ADRs' incidences, prognoses, economical and public health impacts for TB patients and TB control, and build a DNA bank of TB patients. Metho...

  1. Effect of the UK’s revised paracetamol poisoning management guidelines on admissions, adverse reactions and costs of treatment

    OpenAIRE

    Bateman, D Nicholas; Carroll, Robert; Pettie, Janice; Yamamoto, Takahiro; Elamin, Muhammad E. M. O.; Peart, Lucy; Dow, Margaret; Coyle, Judy; Cranfield, Kristina R; Hook, Christopher; Sandilands, Euan A; Veiraiah, Aravindan; Webb, David; Gray, Alasdair; Dargan, Paul I

    2014-01-01

    AIMSIn September 2012 the UK's Commission on Human Medicines (CHM) recommended changes in the management of paracetamol poisoning: use of a single '100 mg l(-1)' nomogram treatment line, ceasing risk assessment, treating all staggered/uncertain ingestions and increasing the duration of the initial acetylcysteine (NAC) infusion from 15 to 60 min. We evaluated the effect of this on presentation, admission, treatment, adverse reactions and costs of paracetamol poisoning.METHODSData were prospect...

  2. Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA

    OpenAIRE

    Eriksson, Robert; Aagaard, Lise; Jensen, Lars Juhl; Borisova, Liza; Hørlück, Dorte; Brunak, Søren; Hansen, Ebba Holme

    2014-01-01

    Pharmaceutical product information (PI) supplied by the regulatory authorities serves as a source of information on safe and effective use of drugs. The objectives of this study were to qualitatively and quantitatively compare PIs for selected drugs marketed in both Denmark and the USA with respect to consistency and discrepancy of listed adverse drug reaction (ADR) information. We compared individual ADRs listed in PIs from Denmark and the USA with respect to type and frequency. Consistency ...

  3. The Impact of Herbal Drug Use on Adverse Drug Reaction Profiles of Patients on Antiretroviral Therapy in Zimbabwe

    OpenAIRE

    Gene D. Morse; Qing Ma; Star Khoza; Tinashe Mudzviti; Maponga, Charles C.

    2012-01-01

    Background. The main objective was to determine the impact of herbal drug use on adverse drug reactions in patients on antiretroviral therapy (ART). Methodology. Patients receiving first-line ART from the national roll-out program participated in this cross-sectional study. Participants were interviewed and a data collection sheet was used to collect information from the corresponding medical record. Results. The majority (98.2%) of participants were using at least one herbal drug together wi...

  4. 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. PMID:25000711

  5. Critically appraised topic on adverse food reactions of companion animals (2): common food allergen sources in dogs and cats

    OpenAIRE

    Mueller, Ralf S.; Olivry, Thierry; Prélaud, Pascal

    2016-01-01

    Background To diagnose cutaneous adverse food reactions (CAFRs) in dogs and cats, dietary restriction-provocation trials are performed. Knowing the most common offending food allergens for these species would help determining the order of food challenges to optimize the time to diagnosis. Results The search for, and review and analysis of the best evidence available as of January 16, 2015 suggests that the most likely food allergens contributing to canine CAFRs are beef, dairy products, chick...

  6. Histopathological characterization of corrosion product associated adverse local tissue reaction in hip implants: a study of 285 cases

    OpenAIRE

    Ricciardi, Benjamin F.; Nocon, Allina A.; Jerabek, Seth A.; Wilner, Gabrielle; Kaplowitz, Elianna; Goldring, Steven R.; Purdue, P Edward; Perino, Giorgio

    2016-01-01

    Background Adverse local tissue reaction (ALTR), characterized by a heterogeneous cellular inflammatory infiltrate and the presence of corrosion products in the periprosthetic soft tissues, has been recognized as a mechanism of failure in total hip replacement (THA). Different histological subtypes may have unique needs for longitudinal clinical follow-up and complication rates after revision arthroplasty. The purpose of this study was to describe the histological patterns observed in the per...

  7. Hospitalization in older patients due to adverse drug reactions –the need for a prediction tool

    OpenAIRE

    Parameswaran Nair, Nibu

    2016-01-01

    Nibu Parameswaran Nair, Leanne Chalmers, Gregory M Peterson, Bonnie J Bereznicki, Ronald L Castelino, Luke R Bereznicki Division of Pharmacy, School of Medicine, Faculty of Health, University of Tasmania, Hobart, TAS, Australia Abstract: Adverse drug reactions (ADRs) represent a major burden on society, resulting in significant morbidity, mortality, and health care costs. Older patients living in the community are particularly susceptible to ADRs, and are at an increased risk of ADR-related...

  8. Hospitalization in older patients due to adverse drug reactions – the need for a prediction tool

    OpenAIRE

    Parameswaran Nair N; Chalmers L; Peterson GM; Bereznicki BJ; Castelino RL; Bereznicki LR

    2016-01-01

    Nibu Parameswaran Nair, Leanne Chalmers, Gregory M Peterson, Bonnie J Bereznicki, Ronald L Castelino, Luke R Bereznicki Division of Pharmacy, School of Medicine, Faculty of Health, University of Tasmania, Hobart, TAS, Australia Abstract: Adverse drug reactions (ADRs) represent a major burden on society, resulting in significant morbidity, mortality, and health care costs. Older patients living in the community are particularly susceptible to ADRs, and are at an increased risk of ADR-related...

  9. [Novel oral anticancer drugs: a review of adverse drug reactions, interactions and patient adherence].

    Science.gov (United States)

    Bartal, Alexandra; Mátrai, Zoltán; Szucs, Attila; Belinszkaja, Galina; Langmár, Zoltán; Rosta, András

    2012-01-15

    Each aspect of oncological care is widely affected by the spread of oral anticancer agents, which raises several questions in terms of safe medication use and patient adherence. Over the past decade targeted therapies have appeared in clinical practice and revolutionized the pharmacological treatment of malignancies. Regular patient - doctor visits and proper patient education is crucial in order to comply with the therapy previously agreed upon with the oncologist, to increase patient adherence, to detect and to treat adverse effects in early stages. Since the information on the new medicines in Hungarian language is sparse it is the intention of the authors to give an overview of the basic knowledge, patient safety issues, adverse effects and interactions. Official drug information summaries and data on pharmacokinetics, interactions and adverse effects from the literature are reviewed as the basis for this overview. PMID:22217686

  10. 120例胺碘酮不良反应分析%Analysis of 120 amiodarone adverse reactions

    Institute of Scientific and Technical Information of China (English)

    彭庚; 谢文燕; 刘东亮; 董艳彩

    2015-01-01

    Objective To investigate adverse drug reaction (ADR) caused by amiodarone, in order to provide reference for clinical safety and rational drug use.Methods There were 120 patients with adverse drug reaction cases caused by amiodarone. Statistical analysis was made on their age, gender, underlying disease, administration route, drug dosage, history and clinical manifestation of adverse reactions.Results Among 120 patients with amiodarone ADR, there were 77 male (64.17%) and 43 female (35.83%). There were 83 cases over 60-year-old (69.17%). 107 cases had circulation system disease as mainly underlying disease (89.17%). 101 cases had arrhythmia as administration reason (84.17%), among them atrial fibrillation was the main cause with 56 cases (46.67%). There were 2 administration routes, as oral administration in 27 cases (22.50%) and intravenous administration in 93 cases (77.50%). Among reports of 120 ADR cases, there were 100 cases with normal ADR(83.33%), and 20 cases with severe ADR (16.67%). Main clinical manifestations included hepatic damage, phlebitis, anaphylactoid reaction, lung damage, hypotension, arrhythmia, and thyroid dysfunction. After measures of dose decrease and drug withdrawal, there were 35 cured cases (29.17%), 76 improved cases (63.33%), 8 cases with sequelae (6.67%), and 1 death case (0.83%).Conclusion As a safe antiarrhythmic agent in clinical application, amiodarone still provides various ADR manifestations. Close monitoring on ADR in clinical work is necessary for reducing incidence of severe adverse reactions.%目的:探讨胺碘酮所致不良反应(ADR)的发生情况,为临床安全、合理用药提供参考。方法120例胺碘酮所致不良反应患者,对其年龄、性别、基础疾病、用药途径、用药剂量、不良反应史、不良反应的临床表现等进行统计分析。结果120例胺碘酮ADR患者中,男77例(64.17%),女43例(35.83%),发生在60岁以上病例83例(69.17%);原患疾病以

  11. Pharmacovigilance Analysis of Serious Adverse Events Reported for Biologic Response Modifiers Used as Prophylaxis against Transplant Rejection: a Real-World Postmarketing Experience from the US FDA Adverse Event Reporting System (FAERS

    Directory of Open Access Journals (Sweden)

    A. K. Ali

    2013-04-01

    Full Text Available Background: Immunosuppression by biologic response modifiers (BRM is a crucial component for successfulorgan transplantation. In addition to their variable effectiveness in the prevention of organ rejection,these medications have safety concerns that complicate therapeutic outcomes in organ transplantpatients.Objective: This study aims at identifying and characterizing safety signals of serious adverse events associatedwith exposure to BRM among organ transplant patients in a real-world environment.Methods: The FDA Adverse Event Reporting System was utilized to apply a pharmacovigilance disproportionalityanalysis to indentify serious adverse events. Associations between drugs and events weremeasured by empirical Bayes geometric mean (EBGM and the corresponding 95% confidence intervals(EB05–EB95. Associations with EBGM≥2 were considered significant safety signals.Results: From 1997 to 2012, a total of 12,151 serious adverse event reports for BRM were reported; 15.6%of them (n=1,711 met the safety signal threshold of EB05>1, and 11.6% of these signals (n=199 weresignificant (EBGM≥2. Sirolimus and mycophenolate accounted for the majority of all signals; antithymocyteimmunoglobulin (ATI and cyclosporine contributed to the majority of significant signals. The followingsignificant signals were identified for ATI (reduced therapeutic response, pulmonary edema, hypotension,serum sickness, infusion-related reaction, and anaphylactic reaction; for azathioprine (alternariainfection, fungal skin infection, and lymphoproliferative disorder; for cyclosporine (neurotoxicity,graft vs. host disease, and thyroid cancer; for cyclophosphamide (disease progression; for daclizumab(cytomegalovirus infection; and for tacrolimus (coma and tremor. 33.6% of these events contributedto patient death (n=67; 6.5% were life-threatening (n=13; 32.1% lead to hospitalization (n=64; and27.6% resulted in other serious outcomes (n=55.Conclusion: Utilization of BRM for the

  12. Adverse reactions of ceftriaxone sodium: Analysis of 6916 cases in Jiangsu Province%6916例头孢曲松钠不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    卞蓉蓉; 孙骏

    2012-01-01

    目的 头孢曲松钠临床应用广泛,其不良反应越来越引起重视.文中分析总结江苏省4年来抗感染药物头孢曲松钠的不良反应发生情况及其特点,为临床合理用药提供参考.方法 从江苏省药品不良反应监测中心数据库中提取2007年1月至2010年12月头孢曲松钠所致药物不良反应(adverse drug reaction,ADR)报告6916例,进行回顾性统计分析.结果 10岁以下儿童(18.65%)是高发组.头孢曲松钠所致ADR临床表现以皮肤及其附件损害最多(61.68%),其余依次是全身性损害、胃肠系统损害、药物热、神经系统损害等.结论 临床应重视头孢曲松钠引起ADR的各种因素,加强对其严重不良反应的预防和监测,确保临床安全、有效、合理用药.%Objective With the wide clinical application of ceftriaxone sodium, more and more attention has been drawn to its adverse reactions. This article analyzes the characteristics of the adverse drug reactions ( ADR ) of ceftriaxone sodium in Jiangsu Province to provide some reference for rational and safe medication in clinical practice. Methods We retrospectively analyzed 69f6 cases of adverse reactions of ceftriaxone sodium reported from Jan. 2007 to Dec. 20f0 from the database of our center. Results Children under the age of fO years was a high-risk cohort, with an ADR incidence of f8.65%. The clinical manifestations of the adverse reactions of ceftriaxone sodium were mostly skin lesions ( 61. 68% ), followed by systemic problems, gastrointestinal disorders, drug fever, and central and peripheral nervous system involvement. Conclusion Attention should be paid to the multiple factors causing serious ADRs of ceftriaxone sodium, and strengthened measures are necessitated for the prevention and control of ADRs.

  13. 21 CFR 314.80 - Postmarketing reporting of adverse drug experiences.

    Science.gov (United States)

    2010-04-01

    ... then at annual intervals. The applicant shall submit each quarterly report within 30 days of the close... annual report within 60 days of the anniversary date of approval of the application. Upon written notice... § 314.80 Postmarketing reporting of adverse drug experiences. (a) Definitions. The following...

  14. Adverse event reporting in Slovenia - the influence of safety culture, supervisors and communication

    Directory of Open Access Journals (Sweden)

    Birk Karin

    2016-01-01

    Full Text Available Background/Aim. The provision of safe healthcare is considered a priority in European Union (EU member states. Along with other preventative measures in healthcare, the EU also strives to eliminate the “causes of harm to human health”. The aim of this survey was to determine whether safety culture, supervisors and communication between co-workers influence the number of adverse event reports submitted to the heads of clinical departments and to the management of an institution. Methods. This survey is based on cross-sectional analysis. It was carried out in the largest Slovenian university hospital. We received 235 completed questionnaires. Respondents included professionals in the fields of nursingcare, physiotherapy, occupational therapy and radiological technology. Results. Safety culture influences the number of adverse event reports submitted to the head of a clinical department from the organizational point of view. Supervisors and communication between co-workers do not influence the number of adverse event reports. Conclusion. It can be concluded that neither supervisors nor the level of communication between co-workers influence the frequency of adverse event reporting, while safety culture does influence it from an organizational point of view. The presumed factors only partly influence the number of submitted adverse event reports, thus other causes of under-reporting must be sought elsewhere.

  15. Identification of SNPs associated with susceptibility for development of adverse reactions to radiotherapy.

    Science.gov (United States)

    Rosenstein, Barry S

    2011-02-01

    Although cancer treatment with radiation can produce high cure rates, adverse effects often result from radiotherapy. These toxicities are manifested as damage to normal tissues and organs in the radiation field. In recognition of the substantial variation in the intrinsic response of individuals to radiation, an effort began approximately 10 years ago to discover the genetic markers, primarily SNPs, which are associated with susceptibility for the development of these adverse responses to radiation therapy. The goal of this research is to identify the SNPs that could serve as the basis of an assay to predict which cancer patients are most likely to develop complications resulting from radiotherapy. This would permit personalization and optimization of the treatment plan for each cancer patient. PMID:21332318

  16. Adverse Drug Reaction Mining in Pharmacovigilance data using Formal Concept Analysis

    OpenAIRE

    Villerd, Jean; Toussaint, Yannick; Lillo Le-Louët, Agnès

    2010-01-01

    International audience In this paper we discuss the problem of extracting and evaluating associations between drugs and adverse effects in pharmacovigilance data. Approaches proposed by the medical informatics community for mining one drug - one effect pairs perform an exhaustive search strategy that precludes from mining high-order associations. Some specificities of pharmacovigilance data prevent from applying pattern mining approaches proposed by the data mining community for similar pr...

  17. Role of DNA damage and repair as predeterminant factor in the development of radiotherapy induced acute adverse reactions

    International Nuclear Information System (INIS)

    Radiotherapy induced normal tissue toxicity is one of the major limitations for the compromised the therapeutic outcome and also worsens the quality of life of survivors. Further, the clinical experience demonstrated inter-individual variability with respect to their normal tissue toxicity. Therefore, the discovery of contributing key factors of variability or predicting the risk of developing acute reactions before the initiation of radiation therapy may serve as a powerful predictive biomarker for individualizing radiotherapy, anticipating increased therapeutic effect. DNA double-strand break (DSB) induction and its repair in lymphocytes of head-and-neck and breast cancer patients undergoing chemoradiation or radiation therapy alone were analyzed by performing γ-H2AX foci, neutral comet and a modified neutral filter elution assays. Treatment induced normal tissue adverse reactions (acute skin reaction, oral mucositis) were assessed by the criteria of Radiation Therapy Oncology Group. The residual damage (RD) at 6 hrs of post irradiation was used as parameters to measure cellular radiosensitivity and for its correlation with radiotherapy induced acute reactions in patients stratified as non-over responders (NOR) and over responders (OR). A large inter-individual variation in the radiosensitivity was observed in the cancer individuals with respect to their lymphocyte radiosensitivity and the severity of normal tissue adverse reactions. There was a significant difference in RD (p<0.05) between the NOR and OR in breast cancer radiotherapy. Further, the increased normal tissue toxicity such as oral mucositis and skin reactions was associated with the reduced DSB repair (p<0.05) in head-and-neck cancer patients. The percentile analysis was found to be useful in predicting the OR amongst the head-and-neck cancer patients. Our results suggest that γ-H2AX analysis may have its potential to be developed into a clinically useful predictive assay for identifying the

  18. Incidence of adverse drug reactions in human immune deficiency virus-positive patients using highly active antiretroviral therapy

    Directory of Open Access Journals (Sweden)

    B Akshaya Srikanth

    2012-01-01

    Full Text Available To estimate the incidence of adverse drug reactions (ADRs in Human immune deficiency virus (HIV patients on highly active antiretroviral therapy (HAART. To identify the risk factors associated with ADRs in HIV patients. To analyze reported ADRs based on various parameters like causality, severity, predictability, and preventability. Retrospective case-control study. An 18-month retrospective case-control study of 208 patients newly registered in ART center, RIMS hospital, Kadapa, were intensively monitored for ADRs to HAART. Predictability was calculated based on the history of previous exposure to drug. Multivariate logistic regressions were used to identify the risk factors for ADRs. Data were analyzed using the chi-square test for estimating the correlation between ADRs and different variables. All statistical calculations were performed using EpiInfo version 3.5.3. Monitoring of 208 retrospective patients by active Pharmacovigilance identified 105 ADRs that were identified in 71 patients. Skin rash and anemia were the most commonly observed ADRs. The organ system commonly affected by ADR was skin and appendages (31.57%. The ADRs that were moderate were 90.14% of cases. The incidence of ADRs (53.52% was higher with Zidovudine + Lamivudine + Nevirapine combination. CD4 cell count less than <250 cells/μl were 80.28%, male gender were observed to be the risk factors for ADRs. Our study finding showed that there is a need of active pharmaceutical care with intensive monitoring for ADRs in Indian HIV-positive patients who are illiterate, of male and female gender, with CD4 count ≤250 cells/mm 3 with comorbid conditions.

  19. Incidence of adverse drug reactions in human immune deficiency virus-positive patients using highly active antiretroviral therapy.

    Science.gov (United States)

    Srikanth, B Akshaya; Babu, S Chandra; Yadav, Harlokesh Narayan; Jain, Sunil Kumar

    2012-01-01

    To estimate the incidence of adverse drug reactions (ADRs) in Human immune deficiency virus (HIV) patients on highly active antiretroviral therapy (HAART). To identify the risk factors associated with ADRs in HIV patients. To analyze reported ADRs based on various parameters like causality, severity, predictability, and preventability. Retrospective case-control study. An 18-month retrospective case-control study of 208 patients newly registered in ART center, RIMS hospital, Kadapa, were intensively monitored for ADRs to HAART. Predictability was calculated based on the history of previous exposure to drug. Multivariate logistic regressions were used to identify the risk factors for ADRs. Data were analyzed using the chi-square test for estimating the correlation between ADRs and different variables. All statistical calculations were performed using EpiInfo version 3.5.3. Monitoring of 208 retrospective patients by active Pharmacovigilance identified 105 ADRs that were identified in 71 patients. Skin rash and anemia were the most commonly observed ADRs. The organ system commonly affected by ADR was skin and appendages (31.57%). The ADRs that were moderate were 90.14% of cases. The incidence of ADRs (53.52%) was higher with Zidovudine + Lamivudine + Nevirapine combination. CD4 cell count less than <250 cells/μl were 80.28%, male gender were observed to be the risk factors for ADRs. Our study finding showed that there is a need of active pharmaceutical care with intensive monitoring for ADRs in Indian HIV-positive patients who are illiterate, of male and female gender, with CD4 count ≤250 cells/mm(3) with comorbid conditions. PMID:22470896

  20. Systematic review of antiretroviral-associated lipodystrophy: lipoatrophy, but not central fat gain, is an antiretroviral adverse drug reaction.

    Directory of Open Access Journals (Sweden)

    Reneé de Waal

    Full Text Available BACKGROUND: Lipoatrophy and/or central fat gain are observed frequently in patients on antiretroviral therapy (ART. Both are assumed to be antiretroviral adverse drug reactions. METHODS: We conducted a systematic review to determine whether fat loss or gain was more common in HIV-infected patients on ART than in uninfected controls; was associated with specific antiretrovirals; and would reverse after switching antiretrovirals. RESULTS: Twenty-seven studies met our inclusion criteria. One cohort study reported more lipoatrophy, less subcutaneous fat gain, but no difference in central fat gain in HIV-infected patients on ART than in controls. Randomised controlled trials (RCTs showed more limb fat loss (or less fat gain with the following regimens: stavudine (versus other nucleoside reverse transcriptase inhibitors (NRTIs; efavirenz (versus protease inhibitors (PIs; and NRTI-containing (versus NRTI-sparing. RCTs showed increased subcutaneous fat after switching to NRTI-sparing regimens or from stavudine/zidovudine to abacavir/tenofovir. There were no significant between-group differences in trunk and/or visceral fat gain in RCTs of various regimens, but results from efavirenz versus PI regimens were inconsistent. There was no significant between-group differences in central fat gain in RCTs switched to NRTI-sparing regimens, or from PI-containing regimens. CONCLUSIONS: There is clear evidence of a causal relationship between NRTIs (especially thymidine analogues and lipoatrophy, with concomitant PIs possibly having an ameliorating effect or efavirenz causing additive toxicity. By contrast, central fat gain appears to be a consequence of treating HIV infection, because it is not different from controls, is not linked to any antiretroviral class, and doesn't improve on switching.

  1. In situ simulation: Taking reported critical incidents and adverse events back to the clinic

    DEFF Research Database (Denmark)

    Juul, Jonas; Paltved, Charlotte; Krogh, Kristian;

    2014-01-01

    to explore and improve team processes in the clinical environment. Though research on in situ simulation in healthcare is in its infancy, literature is abundant on patient safety, medical simulation, team training and human factors1. Patient safety reporting systems that identify risks to patients can...... and used for debriefing6 focusing on team communication and team adaptation7 after in situ simulation training. Perspective and relevance First, this study might help taking reported critical incidents and adverse events back to the clinic. Second, reported critical incidents and adverse events coupled...

  2. 75 FR 29352 - Draft Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports...

    Science.gov (United States)

    2010-05-25

    ... of Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability AGENCY: Food... Veterinary Adverse Event Reports to the Center for Veterinary Medicine.'' The purpose of this draft guidance is to assist sponsors or non-applicants with filling out form FDA 1932, ``Veterinary Adverse...

  3. Monitoring of incidence, severity, and causality of adverse drug reactions in hospitalized patients with cardiovascular disease

    Directory of Open Access Journals (Sweden)

    Sharminder Kaur

    2011-01-01

    Conclusion : Development of ADR in one of every five cardiac patient points toward a grave situation, but a higher incidence of Type A reactions in cardiology department means that these can be avoided.

  4. Foreign body reaction due to skin filler: a case report.

    Science.gov (United States)

    Kawamura, Juliana Y; Domaneschi, Carina; Migliari, Dante A; Sousa, Suzana Orsini Machado de

    2006-04-01

    Aquamid represents a new generation of soft-tissue fillers for aesthetic facial correction and reconstruction due to its reduced quantity of particles (2.5% of polyacrylamide) and high concentration of water (97.5%). It is a biocompatible, atoxic, homogeneous, and stable product. Additionally, it has good viscosity and elasticity, and it is very simple to use. Although reported in less than 1% of the cases, adverse effects such as pain, swelling, and erythema may occur, which may be the result of inappropriate injection procedure. This article reports the first case of an intraoral foreign body reaction resulting from Aquamid application in the nasolabial fold. Possible causes for this reaction, the chemical composition of the product, and the histopathologic aspects are discussed. PMID:16545711

  5. General practitioners′ attitudes toward reporting and learning from adverse events: results from a survey

    DEFF Research Database (Denmark)

    Mikkelsen, Thorbjørn H.; Sokolowski, Ineta; Olesen, Frede

    2006-01-01

    OBJECTIVE: To investigate GPs' attitudes to and willingness to report and learn from adverse events and to study how a reporting system should function. DESIGN: Survey. SETTING: General practice in Denmark. MAIN OUTCOME MEASURES: GPs' attitudes to exchange of experience with colleagues and others...

  6. To discuss the adverse reaction of Fluoroquinolones%对氟喹诺酮类药物的不良反应的探讨

    Institute of Scientific and Technical Information of China (English)

    刘伦栋; 徐婷

    2013-01-01

    目的:探讨氟喹诺酮类药物在临床应用中的不良反应。方法:分析研究氟喹诺酮类在临床中的应用及其不良反应。结果与结论:对氟喹诺酮类的不良反应应重视并防止滥用。%objecttive: To discuss the adverse reaction of fluoroquinolones in clinic. Methods:To study and analysis the adverse reaction of fluoroquinolones in clinic. Results & Conclusion: Fluoroquinolones, adverse reaction should be valued and prevent drug abusing.

  7. Atopic diseases: Risk factor in developing adverse reaction to intravenous N-Acetylcysteine

    OpenAIRE

    F Gheshlaghi; Eizadi-Mood, N.

    2006-01-01

    Background: N-acetylcysteine (NAC) is the choice treatment for acetaminophen overdose. The main side effect of intravenous NAC therapy is anaphylaxis or anaphylactoid reactions. We investigated the prevalence of anaphylactoid or anaphylaxis reactions to IV-NAC therapy in acetaminophen poisoned patients with atopic disease. Methods: A case series antrograde and descriptive–analytic study was done on acetaminophen poisoned patients who treated with IV-NAC from September 2003 to September 2...

  8. 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.

  9. Adverse reactions following mass drug administration with diethylcarbamazine in lymphatic filariasis endemic areas in the Northeast of Brazil

    Directory of Open Access Journals (Sweden)

    Ana Wládia Lima

    2012-12-01

    Full Text Available INTRODUCTION: The Global Programme to Eliminate Lymphatic Filariasis was launched with the goal of eliminating this disease via the annual mass drug administration (MDA of a single dose of antifilarial drugs. Adverse drug reactions following MDA are a major factor of poor treatment adherence in several countries. This study assessed the occurrence of adverse drug reactions (ADRs following the first round of mass treatment in two communities treated with different dosages of diethylcarbamazine (DEC in the City of Recife, Brazil. METHODS: Population-based cross-sectional surveys were conducted in a random sample of the population living in both communities (Areas I and II. The dose of DEC recommended by the WHO (6mg/kg was calculated based on the individual's weight-for-age. In Area II, weight differences between the genders were also considered when determining dosage. Data were obtained through interviews conducted in the first 12 to 48h and on the 5th day after MDA during household visits. RESULTS: A total of 487 and 365 individuals were interviewed in Areas I and II, respectively. The prevalence of ADRs in Area I (23.6; 95%CI: 19.1-29.5 was higher than in Area II (16.2; 95%CI:11.9-21.5(p=0.0078. The prevalence of ADRs among females was higher than in males in Area I (p=0.0021. In Area II, no significant difference between the genders was observed (p=0.1840. Age was not associated with ADRs in either area. CONCLUSIONS: Adjusting MDA dosage schedules according to weight-for-age and sex may be may contribute to reduce the occurrence of adverse drug reactions in the population.

  10. CORRELATION OF THE SERUM LEVEL OF CARBAMAZEPINE WITH SEIZURE CONTROL AND ADVERSE DRUG REACTIONS AMONG EPILEPTICS IN IBADAN, NIGERIA

    Directory of Open Access Journals (Sweden)

    Joseph O. Fadare

    2010-12-01

    Full Text Available Background: Epilepsy is a chronic neurological disorder requiring long-term treatment. Seizure control requires adequate blood levels of anti-seizure drugs. Carbarmazepine is one of the most prescribed antiepileptic drugs in Nigeria. This study was carried out to investigate the correlation between serum levels of carbamazepine and seizure control and adverse drug reactions among epileptics in Ibadan, Nigeria. Methods: In a cross-sectional study, sixty-nine patients with confirmed diagnosis of epilepsy who had been on treatment with carbamazepine alone or in combination with phenytoin for at least one month were enrolled into the study and divided into two groups based on seizure control. Drug level in pre-dose (steady state venous blood was analyzed using high performance liquid chromatography. Result: The mean serum concentration of carbamazepine (CBZ and carbamazepine-epoxide (CBZ-EP was 13.5±9.3ìg/mL and 6.34±12.61ìg/mL respectively. Patients with good seizure control had mean serum CBZ concentration of 12.7 ± 9.2ìg/mL versus 15.02 ± 9.7ìg/mL among patients with poor seizure control (P=0.33. The serum concentration of CBZ-EP in patients with good seizure control was 8.05 ± 15.2ìg/mL while it was 3.11 ± 3.5ìg/mL in the second group (P=0.122. Drowsiness was the commonest adverse drug reaction (26.1% and it did not necessitate withdrawal of the drug. Conclusion The study showed that serum level of carbamazepine does not correlate with seizure control and adverse drug reactions.

  11. Surveillance of adverse effects of sanitizers among hospital workers: an experience report

    Directory of Open Access Journals (Sweden)

    Laiane Mucio Correia

    2014-05-01

    Full Text Available Objective: To report the epidemiological surveillance of intoxication from sanitizers using the method of active case finding of hospital workers who experienced adverse effects. Data Synthesis: Experience report of university extension activities developed at the Center for Intoxication Control of the Regional University Hospital of Maringá in the period from 2010 to 2011. The activities focused on the application of the Surveillance-Education-Assistance triad. In all, 25 hospital workers who experienced adverse effects of sanitizers participated in the study. Data collection occurred through documentary research, analysis of monthly reports, and Notification Forms for Adverse Effects. After that, a semistructured interview was conducted with the subjects. Data were compared with the literature, and the results were presented in three moments: description of the active case finding process; exposure of the settings and implementation of the experience, and conclusive analysis of the experience. The main complaints of the interviewees were nasal congestion, burning eyes, sore throat and headache. All the workers reported using Personal Protective Equipment (PPE. However, eight interviewees were referred to the occupational medical service and received guidance on the use of specific PPE. Five of them confirmed following the guidelines and all remained in the same job. Conclusion: The epidemiological and sanitary surveillance of adverse effects of sanitizers among workers and patients of the University Hospital of Maringá hasthe function to identify, analyze and prevent the adverse effects of sanitizers at the hospital and investigate the notifications doi:10.5020/18061230.2013.p442

  12. Adverse events reported for hereditary angioedema medications: a retrospective study of spontaneous reports submitted to the EudraVigilance database, 2007-2013

    Directory of Open Access Journals (Sweden)

    Aagaard L

    2016-05-01

    Full Text Available Lise Aagaard,1 Anette Bygum,2 1Section for Clinical Pharmacology, Institute of Public Health, Faculty of Health Sciences, University of Southern Denmark, 2Department of Dermatology and Allergy Centre, Odense University Hospital, Odense, Denmark Abstract: Information about long-term safety issues from use of orphan drugs in treatment of hereditary angioedema (HAE is limited and must be studied further. As clinical trials in patients with rare diseases are limited, prescribers and patients have to rely on spontaneous adverse drug reaction (ADR reports for obtaining major information about the serious, rarely occurring, and unknown ADRs. In this study, we aimed to characterize ADRs reported for HAE medications in Europe from 2007 to 2013. ADR reports submitted for C1-inibitors and bradykinin receptor antagonists to the European ADR database, EudraVigilance (EV, were included in this study. The ADR reports were categorized with respect to age and sex of the patients, category of the reporter, type and seriousness of the reported ADRs, and medications. The unit of analysis was one adverse event (AE. Totally, 187 AEs were located in EV, and of these, 138 AEs were reported for Cinryze® (C1-inhibitor (73% of the total and 49 AEs for Firazyr® (icatibant (26% of the total AEs. Approximately 60% of all AEs were serious, including three fatal cases. Less than 5% of AEs were reported in children. In total, 62% of AEs were reported for women and 38% for men. For both Cinryze® and Firazyr®, the majority of reported AEs were of the type “general disorders and administration site conditions”. For Cinryze®, a large number of AEs of the type “HAE” and “drug ineffective” was reported, but only few of these were serious. For Firazyr®, several nonserious reports on injection site reactions were reported. In conclusion, this study showed that in EV, several ADR reports from use of HAE medications were identified, and a large number of these were

  13. Statin-associated muscular and renal adverse events: data mining of the public version of the FDA adverse event reporting system.

    Directory of Open Access Journals (Sweden)

    Toshiyuki Sakaeda

    Full Text Available OBJECTIVE: Adverse event reports (AERs submitted to the US Food and Drug Administration (FDA were reviewed to assess the muscular and renal adverse events induced by the administration of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA reductase inhibitors (statins and to attempt to determine the rank-order of the association. METHODS: After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving pravastatin, simvastatin, atorvastatin, or rosuvastatin were analyzed. Authorized 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. Myalgia, rhabdomyolysis and an increase in creatine phosphokinase level were focused on as the muscular adverse events, and acute renal failure, non-acute renal failure, and an increase in blood creatinine level as the renal adverse events. RESULTS: Based on 1,644,220 AERs from 2004 to 2009, signals were detected for 4 statins with respect to myalgia, rhabdomyolysis, and an increase in creatine phosphokinase level, but these signals were stronger for rosuvastatin than pravastatin and atorvastatin. Signals were also detected for acute renal failure, though in the case of atorvastatin, the association was marginal, and furthermore, a signal was not detected for non-acute renal failure or for an increase in blood creatinine level. CONCLUSIONS: Data mining of the FDA's adverse event reporting system, AERS, is useful for examining statin-associated muscular and renal adverse events. The data strongly suggest the necessity of well-organized clinical studies with respect to statin-associated adverse events.

  14. A study of different indicators of Maillard reaction with whey proteins and different carbohydrates under adverse storage conditions.

    Science.gov (United States)

    Leiva, Graciela E; Naranjo, Gabriela B; Malec, Laura S

    2017-01-15

    This study examined different indicators of each stage of Maillard reaction under adverse storage conditions in a system with whey proteins and lactose or glucose. The analysis of lysine loss by the o-phthaldialdehyde method can be considered a good indicator of the early stage, showing considerable differences in reactivity when systems with mono and disaccharides were analyzed. Capillary electrophoresis proved to be a sensitive method for evaluating the extent of glycosylation of the native proteins, providing valuable information when the loss of lysine was not significant. The estimation of the Amadori compound from the determination of total 5-hydroxymethyl-2-furfuraldehyde would have correlate well with reactive lysine content if the advanced stages of the reaction had not been reached. For assessing the occurrence of the intermediate and final stages, the measurement of free 5-hydroxymethyl-2-furfuraldehyde and color, proved not to be suitable for storage conditions. PMID:27542493

  15. Detecting potential adverse reactions of sulpiride in schizophrenic patients by prescription sequence symmetry analysis.

    Directory of Open Access Journals (Sweden)

    Edward Chia-Cheng Lai

    Full Text Available PURPOSE: Previous studies have demonstrated sulpiride to be significantly more effective than haloperidol, risperidone and olanzapine in schizophrenic treatment; however, only limited information is available on the potential risks associated with sulpiride treatment. This study attempts to provide information on the potential risks of sulpiride treatment of schizophrenia, especially with regard to unexpected adverse effects. MATERIALS AND METHODS: Patients with schizophrenia aged 18 and older, newly prescribed with a single antipsychotic medication from the National Health Insurance Research Database of Taiwan in the period from 2003 to 2010 were included. A within-subject comparison method, prescription sequence symmetry analysis (PSSA was employed to efficiently identify potential causal relationships while controlling for potential selection bias. RESULTS: A total of 5,750 patients, with a mean age of 39, approximately half of whom were male, constituted the study cohort. The PSSA found that sulpiride was associated with EPS (adjusted SR, 1.73; 95% CI, 1.46-2.06 and hyperprolactinemia (12.04; 1.59-91.2. In comparison, EPS caused by haloperidol has a magnitude of 1.99 when analyzed with PSSA, and hyperprolactinemia caused by amisulpride has a magnitude of 8.05, respectively. Another finding was the unexpected increase in the use of stomatological corticosteroids, emollient laxatives, dermatological preparations of corticosteroids, quinolone antibacterials, and topical products for joint and muscular pain, after initiation of sulpiride treatment. CONCLUSIONS: We found sulpiride to be associated with an increased risk of EPS and hyperprolactinemia, and the potential risk could be as high as that induced by haloperidol and amisulpride, respectively. Additionally, our study provides grounds for future investigations into the associations between sulpiride and the increased use of additional drugs for managing adverse effects, including

  16. Adverse Events Associated with Yoga: A Systematic Review of Published Case Reports and Case Series

    OpenAIRE

    Cramer, Holger; Krucoff, Carol; Dobos, Gustav

    2013-01-01

    While yoga is gaining increased popularity in North America and Europe, its safety has been questioned in the lay press. The aim of this systematic review was to assess published case reports and case series on adverse events associated with yoga. Medline/Pubmed, Scopus, CAMBase, IndMed and the Cases Database were screened through February 2013; and 35 case reports and 2 case series reporting a total of 76 cases were included. Ten cases had medical preconditions, mainly glaucoma and osteopeni...

  17. Xenobiotic sulphation and its variability during inflammation: a factor in adverse drug reactions?

    Science.gov (United States)

    Waring, R H; Harris, R M; Hunter, J O; Mitchell, S C

    2013-03-01

    The interactions between disease processes and the metabolism of therapeutic drugs have not been systematically investigated. Inflammation, with the presence of pro-inflammatory cytokines, affects Phase 1 metabolism, particularly the activity of the CYP isoforms. Inflammatory factors also alter the activity of some Phase 2 enzymes, particularly the sulphotransferases (SULT isoforms) responsible for drug sulphonation and the enzyme pathway involved in the supply of sulphate for this reaction. Being ill may, therefore, in itself make drug metabolism unpredictable. PMID:23176089

  18. [Analysis of the cardiac side effects of antipsychotics: Japanese Adverse Drug Event Report Database (JADER)].

    Science.gov (United States)

    Ikeno, Takashi; Okumara, Yasuyuki; Kugiyama, Kiyotaka; Ito, Hiroto

    2013-08-01

    We analyzed the cases of side effects due to antipsychotics reported to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) from Jan. 2004 to Dec. 2012. We used the Japanese Adverse Drug Event Report Database (JADER) and analyzed 136 of 216,945 cases using the defined terms. We also checked the cardiac adverse effects listed in the package inserts of the antipsychotics involved. We found cases of Ikr blockade resulting in sudden death (49 cases), electrocardiogram QT prolonged (29 cases), torsade de pointes (TdP, 19 cases), ventricular fibrillation (VF, 10 cases). M2 receptor blockade was observed in tachycardia (8 cases) and sinus tachycardia (3 cases). Calmodulin blockade was involved in reported cardiomyopathy (3 cases) and myocarditis (1 case). Multiple adverse events were reported simultaneously in 14 cases. Our search of package inserts revealed warnings regarding electrocardiogram QT prolongation (24 drugs), tachycardia (23), sudden death (18), TdP (14), VF (3), myocarditis (1) and cardiomyopathy (1). We suggest that when an antipsychotic is prescribed, the patient should be monitored regularly with ECG, blood tests, and/or biochemical tests to avoid adverse cardiac effects. PMID:25069255

  19. Insulin Injection Site Dystrophic Calcification with Fat Necrosis: A Case Report of an Uncommon Adverse Effect

    OpenAIRE

    Ramdas, Sharad; Ramdas, Anita; Ambroise, Moses

    2014-01-01

    We report a case of an uncommon adverse effect of insulin injection resulting in hard subcutaneous swelling in the lower abdomen of a 47-year-oldfemale with type 1 diabetes. Extensive dystrophic calcification and fat necrosis was revealed on histopathological examination.

  20. 76 FR 57045 - Announcement of Requirements and Registration for “Reporting Device Adverse Events Challenge”

    Science.gov (United States)

    2011-09-15

    ...Medical devices will play an increasingly large role in the monitoring and collection of patient data with the spread of electronic health records. The United States has a limited system for the post- market surveillance of medical devices, specifically as it relates to monitoring product safety and effectiveness. The ``Reporting Device Adverse Events Challenge'' asks multi-disciplinary teams......

  1. Adverse respiratory reactions to aspirin and nonsteroidal anti-inflammatory drugs.

    Science.gov (United States)

    Simon, Ronald A

    2004-01-01

    Aspirin-exacerbated respiratory disease (AERD) is an adult-onset condition that manifests as asthma, rhinosinusitis/nasal polyps, and sensitivity to aspirin and other cyclooxygenase-1 (COX-1)-inhibitor nonsteroidal anti-inflammatory drugs (NSAIDs). There is no cross-sensitivity to highly selective COX-2 inhibitors. AERD is chronic and does not improve with avoidance of COX-1 inhibitors. The diagnosis of AERD is made through provocative challenge testing. Following a positive aspirin challenge, patients can be desensitized to aspirin and NSAIDs. The desensitized state can be maintained indefinitely with continued daily administration. After desensitization, there is an approximately 48-hour refractory period to adverse effects from aspirin. The pathogenesis of AERD remains unknown, but these patients have been shown to have multiple abnormalities in arachidonic acid metabolism and in cysteinyl leukotriene 1 receptors. AERD patients can take up to 650 mg of acetaminophen for analgesic or antipyretic relief. Patients can also use weak COX-1 inhibitors, such as sodium salicylate or choline magnesium trisalicylate. Treatment of AERD patients with antileukotriene medications has been helpful but not preferential when compared with non-AERD patients. An alternative treatment for many AERD patients is aspirin desensitization. This is particularly effective in reducing upper-airway mucosal congestion, nasal polyp formation, and systemic steroids. PMID:14680616

  2. Repeat survey of current practice regarding corticosteroid prophylaxis for patients at increased risk of adverse reaction to intravascular contrast agents

    Energy Technology Data Exchange (ETDEWEB)

    Radhakrishnan, S. [Department of Radiology, Wishaw General Hospital, Lanarkshire Acute Hospitals NHS Trust, 50, Netherton Street, Wishaw, Lanarkshire ML2 0DP (United Kingdom)]. E-mail: sureshradhakrish@hotmail.com; Manoharan, S. [Department of Radiology, Wishaw General Hospital, Lanarkshire Acute Hospitals NHS Trust, 50, Netherton Street, Wishaw, Lanarkshire ML2 0DP (United Kingdom); Fleet, M. [Department of Radiology, Wishaw General Hospital, Lanarkshire Acute Hospitals NHS Trust, 50, Netherton Street, Wishaw, Lanarkshire ML2 0DP (United Kingdom)

    2005-01-01

    AIM: To compare the findings of a survey undertaken by us in 2002 regarding steroid premedication given in radiology departments to reduce the risk of adverse reactions in patients at increased risk of intravascular contrast media reactions with a similar survey published in 1994 by R. Seymour et al. The high risk patients considered in our survey were patients with history of asthma, drug allergies, hay fever and eczema. MATERIALS AND METHODS: A total of 225 questionnaires were sent to the consultant in charge for audit for radiology departments from the list given by the Royal College of Radiologists. 175 of the 225 questionnaires were returned (response rate 77.8%) and of these 172 were analysed with respect to the type, dose and duration of steroids. RESULTS: Compared to the survey in 1994, it was found that the number of departments who use steroid cover for all category of risk factors had increased compared to previous survey (73.8% in 2002 versus 55.3% in 1994 (p=0.001). There is now almost universal use of non-ionic contrast 98.8% versus 82.4% in 1994 (p=0.001). There is no agreed policy among radiology departments for the need or the dose or duration of steroid cover. CONCLUSION: Despite the more widespread use of non-ionic contrast media, the use of steroid premedication has increased which is contrary to what is expected as the incidence of adverse reaction to non ionic media is less than ionic contrast media.

  3. Mixed-effects Poisson regression analysis of adverse event reports: the relationship between antidepressants and suicide.

    Science.gov (United States)

    Gibbons, Robert D; Segawa, Eisuke; Karabatsos, George; Amatya, Anup K; Bhaumik, Dulal K; Brown, C Hendricks; Kapur, Kush; Marcus, Sue M; Hur, Kwan; Mann, J John

    2008-05-20

    A new statistical methodology is developed for the analysis of spontaneous adverse event (AE) reports from post-marketing drug surveillance data. The method involves both empirical Bayes (EB) and fully Bayes estimation of rate multipliers for each drug within a class of drugs, for a particular AE, based on a mixed-effects Poisson regression model. Both parametric and semiparametric models for the random-effect distribution are examined. The method is applied to data from Food and Drug Administration (FDA)'s Adverse Event Reporting System (AERS) on the relationship between antidepressants and suicide. We obtain point estimates and 95 per cent confidence (posterior) intervals for the rate multiplier for each drug (e.g. antidepressants), which can be used to determine whether a particular drug has an increased risk of association with a particular AE (e.g. suicide). Confidence (posterior) intervals that do not include 1.0 provide evidence for either significant protective or harmful associations of the drug and the adverse effect. We also examine EB, parametric Bayes, and semiparametric Bayes estimators of the rate multipliers and associated confidence (posterior) intervals. Results of our analysis of the FDA AERS data revealed that newer antidepressants are associated with lower rates of suicide adverse event reports compared with older antidepressants. We recommend improvements to the existing AERS system, which are likely to improve its public health value as an early warning system. PMID:18404622

  4. 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

    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. METHOD: 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. RESULTS: Hundred...

  5. Under-reporting of maternal and perinatal adverse events in New Zealand

    OpenAIRE

    Farquhar, Cynthia; Armstrong, Sarah; Kim, Boa; Masson, Vicki; Sadler, Lynn

    2015-01-01

    Objectives To determine the proportion of maternal and perinatal mortality and morbidity cases, identified by the Perinatal and Maternal Mortality Review Committee (PMMRC), that are also reported within the annual serious adverse events (SAEs) reports published by the Health Quality and Safety Commission (HQSC). Setting Nationally collated data from the PMMRC and HQSC, New Zealand. Participants Analysis of maternal and perinatal mortality and morbidity data 2009–2012. Interventions Every SAE ...

  6. Post-marketing assessment of the safety of strontium ranelate; a novel case-only approach to the early detection of adverse drug reactions

    OpenAIRE

    Grosso, A.; Douglas, I.; Hingorani, A.; MacAllister, R.; Smeeth, L

    2008-01-01

    AIMSPost licensing, the evaluation of drug safety relies heavily on the collation of sporadic, spontaneous reports on adverse effects. The aim was to assess the potential utility of a more systematic approach to the detection of adverse events that utilizes routinely collected clinical data from a large primary care population.METHODSWe used the UK General Practice Research Database to assess the risk of several recently reported adverse events linked to the use of strontium ranelate for oste...

  7. Factors affecting the development of adverse drug reactions to β-blockers in hospitalized cardiac patient population

    Directory of Open Access Journals (Sweden)

    Mugoša S

    2016-08-01

    Full Text Available Snežana Mugoša,1,2 Nataša Djordjević,3 Nina Djukanović,4 Dragana Protić,5 Zoran Bukumirić,6 Ivan Radosavljević,7 Aneta Bošković,8 Zoran Todorović5,9 1Department of Pharmacotherapy, Faculty of Pharmacy, University of Montenegro, 2Clinical Trial Department, Agency for Medicines and Medical Devices of Montenegro, Podgorica, Montenegro; 3Department of Pharmacology and Toxicology, Faculty of Medical Sciences, University of Kragujevac, Kragujevac, 4High Medical School “Milutin Milanković”, Belgrade, 5Department of Pharmacology, Clinical Pharmacology and Toxicology, 6Institute for Medical Statistics and Informatics, Faculty of Medicine, University of Belgrade, Belgrade, 7Department of Surgery, Faculty of Medical Sciences, University of Kragujevac, Kragujevac, Serbia; 8Clinic for Heart Diseases, Clinical Centre of Montenegro, Podgorica, Montenegro; 9Department of Clinical Immunology and Allergy, Medical Center “Bežanijska kosa”, Belgrade, Serbia Abstract: The aim of the present study was to undertake a study on the prevalence of cytochrome P450 2D6 (CYP2D6 poor metabolizer alleles (*3, *4, *5, and *6 on a Montenegrin population and its impact on developing adverse drug reactions (ADRs of β-blockers in a hospitalized cardiac patient population. A prospective study was conducted in the Cardiology Center of the Clinical Center of Montenegro and included 138 patients who had received any β-blocker in their therapy. ADRs were collected using a specially designed questionnaire, based on the symptom list and any signs that could point to eventual ADRs. Data from patients’ medical charts, laboratory tests, and other available parameters were observed and combined with the data from the questionnaire. ADRs to β-blockers were observed in 15 (10.9% patients. There was a statistically significant difference in the frequency of ADRs in relation to genetically determined enzymatic activity (P<0.001, with ADRs’ occurrence significantly

  8. Mining multi-item drug adverse effect associations in spontaneous reporting systems

    Directory of Open Access Journals (Sweden)

    Chase Herbert S

    2010-10-01

    Full Text Available Abstract Background Multi-item adverse drug event (ADE associations are associations relating multiple drugs to possibly multiple adverse events. The current standard in pharmacovigilance is bivariate association analysis, where each single drug-adverse effect combination is studied separately. The importance and difficulty in the detection of multi-item ADE associations was noted in several prominent pharmacovigilance studies. In this paper we examine the application of a well established data mining method known as association rule mining, which we tailored to the above problem, and demonstrate its value. The method was applied to the FDAs spontaneous adverse event reporting system (AERS with minimal restrictions and expectations on its output, an experiment that has not been previously done on the scale and generality proposed in this work. Results Based on a set of 162,744 reports of suspected ADEs reported to AERS and published in the year 2008, our method identified 1167 multi-item ADE associations. A taxonomy that characterizes the associations was developed based on a representative sample. A significant number (67% of the total of potential multi-item ADE associations identified were characterized and clinically validated by a domain expert as previously recognized ADE associations. Several potentially novel ADEs were also identified. A smaller proportion (4% of associations were characterized and validated as known drug-drug interactions. Conclusions Our findings demonstrate that multi-item ADEs are present and can be extracted from the FDA’s adverse effect reporting system using our methodology, suggesting that our method is a valid approach for the initial identification of multi-item ADEs. The study also revealed several limitations and challenges that can be attributed to both the method and quality of data.

  9. Motor palsies of cranial nerves (excluding VII) after vaccination: Reports to the US Vaccine Adverse Event Reporting System

    OpenAIRE

    Woo, Emily Jane; Winiecki, Scott K.; Ou, Alan C

    2013-01-01

    We reviewed cranial nerve palsies, other than VII, that have been reported to the US Vaccine Adverse Event Reporting System (VAERS). We examined patterns for differences in vaccine types, seriousness, age, and clinical characteristics. We identified 68 reports of cranial nerve palsies, most commonly involving the oculomotor (III), trochlear (IV), and abducens (VI) nerves. Isolated cranial nerve palsies, as well as palsies occurring as part of a broader clinical entity, were reported. Forty re...

  10. Characterization of hypersensitivity reactions reported among Andrographis paniculata users in Thailand using Health Product Vigilance Center (HPVC) database

    OpenAIRE

    Suwankesawong, Wimon; Saokaew, Surasak; Permsuwan, Unchalee; Chaiyakunapruk, Nathorn

    2014-01-01

    Background Andrographis paniculata (andrographis) is one of the herbal products that are widely used for various indications. Hypersensitivity reactions have been reported among subjects receiving Andrographis paniculata in Thailand. Understanding of characteristics of patients, adverse events, and clinical outcomes is essential for ensuring population safety. This study aimed to describe the characteristics of hypersensitivity reactions reported in patients receiving andrographis containing ...

  11. Quality of Reporting of Serious Adverse Drug Events to an Institutional Review Board

    Science.gov (United States)

    Dorr, David A.; Burdon, Rachel; West, Dennis P.; Lagman, Jennifer; Georgopoulos, Christina; Belknap, Steven M.; McKoy, June M.; Djulbegovic, Benjamin; Edwards, Beatrice J.; Weitzman, Sigmund A.; Boyle, Simone; Tallman, Martin S.; Talpaz, Moshe; Sartor, Oliver; Bennett, Charles L.

    2009-01-01

    Purpose Serious adverse drug event (sADE) reporting to Institutional Review Boards (IRB) is essential to ensure pharmaceutical safety. However, the quality of these reports has not been studied. Safety reports are especially important for cancer drugs that receive accelerated Food and Drug Administration approval, like imatinib, as preapproval experience with these drugs is limited. We evaluated the quality, accuracy, and completeness of sADE reports submitted to an IRB. Experimental Design sADE reports submitted to an IRB from 14 clinical trials with imatinib were reviewed. Structured case report forms, containing detailed clinical data fields and a validated causality assessment instrument, were developed. Two forms were generated for each ADE, the first populated with data abstracted from the IRB reports, and the second populated with data from the corresponding clinical record. Completeness and causality assessments were evaluated for each of the two sources, and then compared. Accuracy (concordance between sources) was also assessed. Results Of 115 sADEs reported for 177 cancer patients to the IRB, overall completeness of adverse event descriptions was 2.4-fold greater for structured case report forms populated with information from the clinical record versus the corresponding forms from IRB reports (95.0% versus 40.3%, P < 0.05). Information supporting causality assessments was recorded 3.5-fold more often in primary data sources versus IRB adverse event descriptions (93% versus 26%, P < 0.05). Some key clinical information was discrepant between the two sources. Conclusions The use of structured syndrome-specific case report forms could enhance the quality of reporting to IRBs, thereby improving the safety of pharmaceuticals administered to cancer patients. PMID:19458059

  12. Quality review of an adverse incident reporting system and root cause analysis of serious adverse surgical incidents in a teaching hospital of Scotland

    Directory of Open Access Journals (Sweden)

    Khorsandi Maziar

    2012-08-01

    Full Text Available Abstract Background A significant proportion of surgical patients are unintentionally harmed during their hospital stay. Root Cause Analysis (RCA aims to determine the aetiology of adverse incidents that lead to patient harm and produce a series of recommendations, which would minimise the risk of recurrence of similar events, if appropriately applied to clinical practice. A review of the quality of the adverse incident reporting system and the RCA of serious adverse incidents at the Department of Surgery of Ninewells hospital, in Dundee, United Kingdom was performed. Methods The Adverse Incident Management (AIM database of the Department of Surgery of Ninewells Hospital was retrospectively reviewed. Details of all serious (red, sentinel incidents recorded between May 2004 and December 2009, including the RCA reports and outcomes, where applicable, were reviewed. Additional related information was gathered by interviewing the involved members of staff. Results The total number of reported surgical incidents was 3142, of which 81 (2.58% cases had been reported as red or sentinel. 19 of the 81 incidents (23.4% had been inappropriately reported as red. In 31 reports (38.2% vital information with regards to the details of the adverse incidents had not been recorded. In 12 cases (14.8% the description of incidents was of poor quality. RCA was performed for 47 cases (58% and only 12 cases (15% received recommendations aiming to improve clinical practice. Conclusion The results of our study demonstrate the need for improvement in the quality of incident reporting. There are enormous benefits to be gained by this time and resource consuming process, however appropriate staff training on the use of this system is a pre-requisite. Furthermore, sufficient support and resources are required for the implementation of RCA recommendations in clinical practice.

  13. A rare adverse reaction to ethambutol: drug-induced haemolytic anaemia.

    Science.gov (United States)

    Nicolini, A; Perazzo, A; Gatto, P; Piroddi, I M G; Barlascini, C; Karamichali, S; Strada, P

    2016-05-01

    Anti-tuberculosis drugs seldom cause serious haematological side effects. However, among these drugs, isoniazid and rifampicin, especially when administered intermittently, may very rarely be linked to acute autoimmune haemolytic anaemia. Ethambutol (EMB) can cause dose-related retrobulbar neuritis. In this paper, we present the first reported case of acute fatal autoimmune haemolytic anaemia due to EMB. PMID:27084828

  14. Study of adverse drug reactions in a tertiary care teaching hospital

    Directory of Open Access Journals (Sweden)

    Ramya Ravichandar

    2016-02-01

    Conclusions: The study accomplished that ADRs are widespread and a few of them raised the healthcare expenditure due to the increased hospital stay. The reporting of ADRs to regional pharmacovigilance centres should be encouraged to ensure drug safety. [Int J Basic Clin Pharmacol 2016; 5(1.000: 209-212

  15. Adverse Reaction to Omalizumab in Patients with Chronic Urticaria: Flare Up or Ineffectiveness?

    Science.gov (United States)

    Ertaş, Ragıp; Özyurt, Kemal; Yıldız, Sinem; Ulaş, Yılmaz; Turasan, Abdullah; Avcı, Atıl

    2016-02-01

    Omalizumab is a recombinant humanized anti-Ig E monoclonal antibody used as the third line treatment of chronic spontaneous urticaria (CSU). We report four patients with severe antihistamine-resistant CSU, who developed angioedema, anaphylaxis and/or flare up of urticaria at different times following omalizumab therapy. PMID:26996116

  16. The impact of herbal drug use on adverse drug reaction profiles of patients on antiretroviral therapy in zimbabwe.

    Science.gov (United States)

    Mudzviti, Tinashe; Maponga, Charles C; Khoza, Star; Ma, Qing; Morse, Gene D

    2012-01-01

    Background. The main objective was to determine the impact of herbal drug use on adverse drug reactions in patients on antiretroviral therapy (ART). Methodology. Patients receiving first-line ART from the national roll-out program participated in this cross-sectional study. Participants were interviewed and a data collection sheet was used to collect information from the corresponding medical record. Results. The majority (98.2%) of participants were using at least one herbal drug together with ART. The most common herbal remedies used were Allium Sativum (72.7%), Bidens pilosa (66.0%), Eucalyptus globulus (52.3%), Moringa oleifera (44.1%), Lippia javanica (36.3%), and Peltoforum africanum (34.3%). Two indigenous herbs, Musakavakadzi (OR = 0.25; 95% CI 0.076-0.828) and Peltoforum africanum (OR = 0.495; 95% CI 0.292-0.839) reduced the occurrence of adverse drug events. Conclusions. The use of herbal drugs is high in the HIV-infected population and there is need for pharmacovigilance programs to recognize the role they play in altering ADR profiles. PMID:22506106

  17. Systematic drug safety evaluation based on public genomic expression (Connectivity Map) data: myocardial and infectious adverse reactions as application cases.

    Science.gov (United States)

    Wang, Kejian; Weng, Zuquan; Sun, Liya; Sun, Jiazhi; Zhou, Shu-Feng; He, Lin

    2015-02-13

    Adverse drug reaction (ADR) is of great importance to both regulatory agencies and the pharmaceutical industry. Various techniques, such as quantitative structure-activity relationship (QSAR) and animal toxicology, are widely used to identify potential risks during the preclinical stage of drug development. Despite these efforts, drugs with safety liabilities can still pass through safety checkpoints and enter the market. This situation raises the concern that conventional chemical structure analysis and phenotypic screening are not sufficient to avoid all clinical adverse events. Genomic expression data following in vitro drug treatments characterize drug actions and thus have become widely used in drug repositioning. In the present study, we explored prediction of ADRs based on the drug-induced gene-expression profiles from cultured human cells in the Connectivity Map (CMap) database. The results showed that drugs inducing comparable ADRs generally lead to similar CMap expression profiles. Based on such ADR-gene expression association, we established prediction models for various ADRs, including severe myocardial and infectious events. Drugs with FDA boxed warnings of safety liability were effectively identified. We therefore suggest that drug-induced gene expression change, in combination with effective computational methods, may provide a new dimension of information to facilitate systematic drug safety evaluation. PMID:25576362

  18. In vitro testing for diagnosis of idiosyncratic adverse drug reactions: Implications for pathophysiology.

    Science.gov (United States)

    Elzagallaai, Abdelbaset A; Rieder, Michael J

    2015-10-01

    Idiosyncratic drug reactions (IDRs) represent a major health problem, as they are unpredictable, often severe and can be life threatening. The low incidence of IDRs makes their detection during drug development stages very difficult causing many post-marketing drug withdrawals and black box warnings. The fact that IDRs are always not predictable based on the drug's known pharmacology and have no clear dose-effect relationship with the culprit drug renders diagnosis of IDRs very challenging, if not impossible, without the aid of a reliable diagnostic test. The drug provocation test (DPT) is considered the gold standard for diagnosis of IDRs but it is not always safe to perform on patients. In vitro tests have the advantage of bearing no potential harm to patients. However, available in vitro tests are not commonly used clinically because of lack of validation and their complex and expensive procedures. This review discusses the current role of in vitro diagnostic testing for diagnosis of IDRs and gives a brief account of their technical and mechanistic aspects. Advantages, disadvantages and major challenges that prevent these tests from becoming mainstream diagnostic tools are also discussed here. PMID:25199801

  19. High-throughput identification of off-targets for the mechanistic study of severe adverse drug reactions induced by analgesics

    International Nuclear Information System (INIS)

    Drugs may induce adverse drug reactions (ADRs) when they unexpectedly bind to proteins other than their therapeutic targets. Identification of these undesired protein binding partners, called off-targets, can facilitate toxicity assessment in the early stages of drug development. In this study, a computational framework was introduced for the exploration of idiosyncratic mechanisms underlying analgesic-induced severe adverse drug reactions (SADRs). The putative analgesic-target interactions were predicted by performing reverse docking of analgesics or their active metabolites against human/mammal protein structures in a high-throughput manner. Subsequently, bioinformatics analyses were undertaken to identify ADR-associated proteins (ADRAPs) and pathways. Using the pathways and ADRAPs that this analysis identified, the mechanisms of SADRs such as cardiac disorders were explored. For instance, 53 putative ADRAPs and 24 pathways were linked with cardiac disorders, of which 10 ADRAPs were confirmed by previous experiments. Moreover, it was inferred that pathways such as base excision repair, glycolysis/glyconeogenesis, ErbB signaling, calcium signaling, and phosphatidyl inositol signaling likely play pivotal roles in drug-induced cardiac disorders. In conclusion, our framework offers an opportunity to globally understand SADRs at the molecular level, which has been difficult to realize through experiments. It also provides some valuable clues for drug repurposing. - Highlights: • A novel computational framework was developed for mechanistic study of SADRs. • Off-targets of drugs were identified in large scale and in a high-throughput manner. • SADRs like cardiac disorders were systematically explored in molecular networks. • A number of ADR-associated proteins were identified

  20. The effect of prophylactic antipyretic administration on post-vaccination adverse reactions and antibody response in children: a systematic review.

    Directory of Open Access Journals (Sweden)

    Rashmi Ranjan Das

    Full Text Available Prophylactic antipyretic administration decreases the post-vaccination adverse reactions. Recent study finds that they may also decrease the antibody responses to several vaccine antigens. This systematic review aimed to assess the evidence for a relationship between prophylactic antipyretic administration, post-vaccination adverse events, and antibody response in children.A systematic search of major databases including MEDLINE and EMBASE was carried out till March 2014. Randomized controlled trials (RCTs comparing prophylactic antipyretic treatment versus placebo post-vaccination in children ≤ 6 years of age were included. Two reviewers independently applied eligibility criteria, assessed the studies for methodological quality, and extracted data [PROSPERO registration: CRD42014009717].Of 2579 citations retrieved, a total of 13 RCTs including 5077 children were included in the review. Prophylactic antipyretic administration significantly reduced the febrile reactions (≥ 38.0 °C after primary and booster vaccinations. Though there were statistically significant differences in the antibody responses between the two groups, the prophylactic PCM group had what would be considered protective levels of antibodies to all of the antigens given after the primary and booster vaccinations. No significant difference in the nasopharyngeal carriage rates (short-term and long-term of H. influenzae or S. pneumoniae serotypes was found between the prophylactic and no prophylactic PCM group. There was a significant reduction in the local and systemic symptoms after primary, but not booster vaccinations.Though prophylactic antipyretic administration leads to relief of the local and systemic symptoms after primary vaccinations, there is a reduction in antibody responses to some vaccine antigens without any effect on the nasopharyngeal carriage rates of S. pneumoniae & H. influenza serotypes. Future trials and surveillance programs should also aim at

  1. Adverse reactions to injectable fillers for cosmetic purposes%注射填充美容的不良反应

    Institute of Scientific and Technical Information of China (English)

    文翔; 李咏; 蒋献

    2015-01-01

    In recent years,there has been a rapid progress in dermal fillers for multiple cosmetic purposes.Dermal fillers can increase facial volume to create a younger-looking appearance.Although dermal fillers are generally regarded as safe soft-tissue fillers,all of them may cause potential adverse reactions.Most adverse reactions are related to injection techniques,and some are associated with the filler itself.Different filler materials have different properties with different risks and requirements for different injection techniques.Hence,suitable materials and proper injection techniques should be cautiously selected at clinics.%近年来用于多种美容用途的皮肤填充剂发展迅速,注射填充技术可以增加面部容量,达到年轻化的外观.虽然普遍认为,皮肤填充剂是一种安全的软组织填充物,但所有填充剂均有可能引起不良反应.大多数不良反应的发生与注射技术有关,也有部分和产品本身有关.不同注射材料的特性、相关注射风险以及注射要求均不同,临床上应选择合适的材料并进行正确的注射.

  2. High-throughput identification of off-targets for the mechanistic study of severe adverse drug reactions induced by analgesics

    Energy Technology Data Exchange (ETDEWEB)

    Pan, Jian-Bo [Department of Chemical Biology, College of Chemistry and Chemical Engineering, The Key Laboratory for Chemical Biology of Fujian Province, Xiamen University, Xiamen, Fujian 361005 (China); Ji, Nan; Pan, Wen; Hong, Ru [State Key Laboratory of Stress Cell Biology, School of Life Sciences, Xiamen University, Xiamen, Fujian 361102 (China); Wang, Hao [Department of Chemical Biology, College of Chemistry and Chemical Engineering, The Key Laboratory for Chemical Biology of Fujian Province, Xiamen University, Xiamen, Fujian 361005 (China); Ji, Zhi-Liang, E-mail: appo@xmu.edu.cn [State Key Laboratory of Stress Cell Biology, School of Life Sciences, Xiamen University, Xiamen, Fujian 361102 (China); Department of Chemical Biology, College of Chemistry and Chemical Engineering, The Key Laboratory for Chemical Biology of Fujian Province, Xiamen University, Xiamen, Fujian 361005 (China)

    2014-01-01

    Drugs may induce adverse drug reactions (ADRs) when they unexpectedly bind to proteins other than their therapeutic targets. Identification of these undesired protein binding partners, called off-targets, can facilitate toxicity assessment in the early stages of drug development. In this study, a computational framework was introduced for the exploration of idiosyncratic mechanisms underlying analgesic-induced severe adverse drug reactions (SADRs). The putative analgesic-target interactions were predicted by performing reverse docking of analgesics or their active metabolites against human/mammal protein structures in a high-throughput manner. Subsequently, bioinformatics analyses were undertaken to identify ADR-associated proteins (ADRAPs) and pathways. Using the pathways and ADRAPs that this analysis identified, the mechanisms of SADRs such as cardiac disorders were explored. For instance, 53 putative ADRAPs and 24 pathways were linked with cardiac disorders, of which 10 ADRAPs were confirmed by previous experiments. Moreover, it was inferred that pathways such as base excision repair, glycolysis/glyconeogenesis, ErbB signaling, calcium signaling, and phosphatidyl inositol signaling likely play pivotal roles in drug-induced cardiac disorders. In conclusion, our framework offers an opportunity to globally understand SADRs at the molecular level, which has been difficult to realize through experiments. It also provides some valuable clues for drug repurposing. - Highlights: • A novel computational framework was developed for mechanistic study of SADRs. • Off-targets of drugs were identified in large scale and in a high-throughput manner. • SADRs like cardiac disorders were systematically explored in molecular networks. • A number of ADR-associated proteins were identified.

  3. Adverse Event Profiles of 5-Fluorouracil and Capecitabine: Data Mining of the Public Version of the FDA Adverse Event Reporting System, AERS, and Reproducibility of Clinical Observations

    Directory of Open Access Journals (Sweden)

    Kaori Kadoyama, Ikuya Miki, Takao Tamura, JB Brown, Toshiyuki Sakaeda, Yasushi Okuno

    2012-01-01

    Full Text Available Objective: The safety profiles of oral fluoropyrimidines were compared with 5-fluorouracil (5-FU using adverse event reports (AERs submitted to the Adverse Event Reporting System, AERS, of the US Food and Drug Administration (FDA.Methods: After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving 5-FU and oral fluoropyrimidines were analyzed. Standardized official pharmacovigilance tools were used for the 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 22,017,956 co-occurrences, i.e., drug-adverse event pairs, found in 1,644,220 AERs from 2004 to 2009, it was suggested that leukopenia, neutropenia, and thrombocytopenia were more frequently accompanied by the use of 5-FU than capecitabine, whereas diarrhea, nausea, vomiting, and hand-foot syndrome were more frequently associated with capecitabine. The total number of co-occurrences was not large enough to compare tegafur, tegafur-uracil (UFT, tegafur-gimeracil-oteracil potassium (S-1, or doxifluridine to 5-FU.Conclusion: The results obtained herein were consistent with clinical observations, suggesting the usefulness of the FDA's AERS database and data mining methods used, but the number of co-occurrences is an important factor in signal detection.

  4. Trimethoprim-Sulfamethoxazole-Induced Rhabdomyolysis; Gabapentin-Induced Hypoglycemia in Diabetic and Nondiabetic Patients; Purple Glove Syndrome After Oral Phenytoin Administration; Acute Dystonic Reaction After Methylphenidate Initiation; Serotonin Syndrome with Vilazodone Monotherapy; Cabozantinib-Associated Dermatologic Adverse Reactions.

    Science.gov (United States)

    Mancano, Michael A

    2015-09-01

    The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@temple.edu). Your report will be published anonymously unless otherwise requested. This feature is provided by the Institute for Safe Medication Practices (ISMP) in cooperation with the FDA's MedWatch program and Temple University School of Pharmacy. ISMP is an FDA MedWatch partner. PMID:26715798

  5. A comprehensive safety analysis confirms rhabdomyolysis as an uncommon adverse reaction in patients treated with trabectedin

    OpenAIRE

    Grosso, Federica; D’Incalci, Maurizio; Cartoafa, Mirela; Nieto, Antonio; Fernández-Teruel, Carlos; Alfaro, Vicente; Lardelli, Pilar; Roy, Elena; Gómez, Javier; Kahatt, Carmen; Soto-Matos, Arturo; Judson, Ian

    2012-01-01

    Purpose This analysis determined the incidence of serious rhabdomyolysis events reported during trabectedin treatment since the first phase I clinical trial in April 1996 up to September 2010. Methods Search was done in the Yondelis® Pharmacovigilance and Clinical Trials databases using a list of terms according to the Medical Dictionary for Regulatory Activities (MedDRA, v. 13.1), followed by a medical review of all cases retrieved. Total estimated sample was 10,841 patients: 2,789 from clin...

  6. An epidemiological and clinical analysis of cutaneous adverse drug reactions seen in a tertiary hospital in Johor, Malaysia

    Directory of Open Access Journals (Sweden)

    Siew-Eng Choon

    2012-01-01

    Full Text Available Background: The prevalence, clinical patterns, and causative drugs of cutaneous adverse drug reactions (cADR vary among the different populations previously studied. Aim: To determine the prevalence, the clinical patterns of drug eruptions, and the common drugs implicated, particularly in severe cADR such as Stevens-Johnson Syndrome/Toxic epidermal necrolysis (SJS/TEN and drug rash with eosinophilia and systemic symptoms (DRESS in our population. Methods: We analyzed the database established for all cADR seen by the department of Dermatology from January 2001 till December 2010. Results: A total of 362 cADR were seen among 42 170 new clinic attendees, yielding an incidence rate of 0.86%. The most common reaction pattern seen was maculopapular eruption (153 cases followed by SJS/TEN (110 cases and DRESS (34 cases. Antibiotics was the most commonly implicated drug group (146 cases followed by anticonvulsants (81 cases and antigout drugs (50 cases. The most frequently implicated drug was allopurinol (50 cases. Carbamazepine, allopurinol, and cotrimoxazole were the three main causative drugs of SJS/TEN accounting for 21.8%, 20.9%, and 12.7%, respectively, of the 110 cases seen, whereas DRESS was mainly caused by allopurinol (15 cases. Mortality rates for TEN, SJS, and DRESS were 28.6%, 2.2%, and 5.9%, respectively Conclusions: The low rate of cADR with a high proportion of severe reactions observed in this study was probably due to referral bias. Otherwise, the reaction patterns and drugs causing cADR in our population were similar to those seen in other countries. Carbamazepine, allopurinol, and cotrimoxazole were the three main causative drugs of SJS/TEN in our population.

  7. Reacciones adversas a fármacos en tuberculosis multirresistente Adverse drug reactions in multidrug-resistant tuberculosis

    Directory of Open Access Journals (Sweden)

    Domingo Palmero

    2010-10-01

    Full Text Available La tuberculosis multidrogorresistente (TBMDR plantea dificultades diagnósticas y terapéuticas; entre ellas, la mayor frecuencia de reacciones adversas a fármacos antituberculosos (RAFAs, que comprometen la eficacia del tratamiento. Más complicado es el panorama del tratamiento en pacientes con la coinfección HIV a los que a la terapia antirretroviral se suma el de las eventuales comorbilidades. Se estudiaron retrospectivamente 121 pacientes: 87 HIV negativos y 34 HIV positivos con TBMDR asistidos en el Hospital F. J. Muñiz en el período 2003-2007, comparándose la incidencia de reacciones adversas entre ambas poblaciones. Fueron incluidos todos los pacientes con adherencia al tratamiento (no más de un abandono recuperado. Los fármacos antituberculosos empleados fueron: etambutol, pirazinamida, ofloxacina, moxifloxacina, cicloserina, etionamida, PAS, estreptomicina, kanamicina, amikacina y linezolid. La aparición de RAFAs así como la proporción de reacciones graves atribuidas a drogas antituberculosas fue similar en los dos grupos (44.8% en HIV negativos y 44.1% en HIV positivos, a quienes se agregó un 23.5% adicional de RAFAs por el tratamiento antirretroviral. Se observaron algunas diferencias en el tipo de reacciones y en el momento de aparición. Un paciente HIV positivo falleció debido a epidermolisis. La proporción de reacciones adversas en HIV/sida aumentó un 50% al considerar también las atribuidas al tratamiento antirretroviral. Se concluye que la población estudiada presentó RAFAs por encima de lo esperable en tuberculosis sensible, pero no se observaron diferencias en la frecuencia de aparición entre pacientes HIV negativos y positivos.Multidrug-resistant tuberculosis (MDRTB poses difficulties in diagnosis and treatment, including increased frequency of adverse reactions to antituberculosis drugs (ADRAs, which compromise the effectiveness of treatment. This is specially complicated in the treatment of patients co

  8. Analysis of 748 cases of quinolone adverse drug reaction in Suzhou city of 2013%2013年宿州市748例喹喏酮类药物不良反应分析

    Institute of Scientific and Technical Information of China (English)

    郭秀秀

    2014-01-01

    目的:研究影响喹诺酮类药物不良反应的因素,以期减少药物不良反应。方法:收集宿州市2013年喹诺酮类合成抗菌药物不良反应报表进行汇总分析。结果:748例喹诺酮类药物不良反应报表以左氧氟沙星引起的不良反应最多(68.14%)。不良反应涉及器官或系统最主要表现在胃肠系统(42.80%)、皮肤(30.64%)、中枢及外周神经系统(5.73%)。结论:应加强喹诺酮类药物的临床监测,提高合理用药的安全性。%Objective Study on the influence factors of adverse drug reactions of quinolones, in order to reduce the occurrence of adverse drug reaction.Methods Collected and analyzed the reports of Quinolones synthetic antibacterial drug adverse reactions in Suzhou city of 2013.Results Levofloxacin induced adverse reaction is most(68.14%)in 748 cases of ADR reports .The adverse drug reactions involving organs or systems mainly reflected in the gastrointestinal system (42.80%), skin (30.64%), the central and peripheral nervous system (5.73%).Conclusion We should strengthen the clinical monitoring of quinolones, to improve security of rational use of drug.

  9. Analysis of Adverse Drug Reaction with Allopurinol Colchicine%别嘌呤醇与秋水仙碱的不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    苏明

    2015-01-01

    Objective To study the clinical adverse reaction analysis of alopurinol and colchicine, and provide reliable reference information for clinical prevention and treatment.Methods According to the adverse reaction of 5 cases in our hospital from 2005 to 2013 of colchicine and 95 patients receiving allopurinol patients with adverse reactions to carry on the research analysis, to explore the adverse reactions of their.Results Among 1 cases of colchicine have serious adverse reaction, which accounted for 20%(1/5), allopurinol has 20 cases of severe adverse reaction, which accounted for 21.05%(20/95); the main adverse reactions to skin and mucous membrane injury, and then is the digestive system adverse drug reaction performance, again is the nervous system and blood system, urinary system injury.Conclusion The clinical use of allopurinol and colchicine should pay attention to drug concentration, control the incidence of clinical adverse reactions of patients, make patients get safe and reliable treatment effect.%目的:研究分析别嘌呤醇和秋水仙碱的临床不良反应情况,为临床预防和治疗提供可靠的参考信息。方法根据我院2005至2013年接收的5例秋水仙碱不良反应和95例别嘌呤不良反应患者来进行研究分析,探讨他们的不良反应情况。结果其中秋水仙碱有1例严重不良反应,占20%(1/5),别嘌呤醇有20例严重不良反应,占21.05%(20/95);不良反应主要以皮肤黏膜损伤为主,然后就是消化系统不良反应表现,再来就是神经系统和血液系统、泌尿系统等的损伤。结论对嘌呤醇和秋水仙碱的临床使用应该要注意药物的浓度,控制患者的临床不良反应发生率,让患者获得安全可靠的治疗效果。

  10. 208例骨瓜提取物注射剂严重不良反应报告分析%Analysis of 208 Cases of Serious Adverse Drug Reactions Induced by Gugua Extracts Injection

    Institute of Scientific and Technical Information of China (English)

    沈晓华; 罗凌凤; 黄亦彬

    2015-01-01

    目的:探讨骨瓜提取物注射剂致严重药品不良反应的规律及特点。方法采用回顾性研究方法,对208份骨瓜提取物注射剂的严重不良反应报告进行统计分析。结果骨瓜提取物注射剂严重不良反应主要表现为过敏性休克、过敏样反应、寒战、呼吸困难和发热等;严重不良反应多在30 min 内发生,其中过敏性休克主要集中在15 min 内发生。结论有必要对骨瓜提取物注射剂说明书进行修改和完善。%Objective To explore the characters of the serious adverse reactions caused by Gugua extracts injection. Methods 208 reports of the serious adverse reactions caused by Gugua extracts injection were analyzed via retrospective study. Results Gugua extracts injection may lead to serious adverse reactions such as anaphylactic shock, anaphylactoid reaction,rigors,dyspnea,fever, etc. The serious adverse reactions occurred within 30 min, and anaphylactic shock occurred within 15 min. Conclusion It is necessary to re-evaluate the risk of serious adverse reactions caused by Gugua extracts injection and modify the drug instructions on this basis.

  11. Analysis of 266 Cases of Adverse Drug Reactions in the Hospital in 2014%医院2014年266例药品不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    蔡乐; 王颖; 史红; 苏晔

    2016-01-01

    目的:了解医院药品不良反应发生的规律及相关因素,为临床合理用药提供参考。方法对北京朝阳医院2014年266例药品不良反应报告进行归类统计、评价。结果266例药品不良反应报告中,患者男性多于女性,比例为1∶0.8,60岁以上老年患者发生不良反应为115例(43.23%)。抗菌药物不良反应发生率最高,其次为抗肿瘤药物。给药途径以静脉滴注为主,不良反应的临床表现以皮肤及其附件损害为主,其次为消化系统、血液系统及全身性损害,分别为31.20%,30.83%,9.77%,9.77%,严重不良反应15例(5.64%)。结论应进一步加强药品不良反应监测情况,加大药品不良反应宣传力度,重视抗菌药物及抗肿瘤药物的不良反应监测,以免发生严重不良反应。%Objective To understand the law of hospital adverse drug reactions and related factors, to provide reference for clinical ratio-nal drug use. Methods 266 cases of adverse drug reaction reports in The Beijing Chaoyang Hospital in 2014 were statistically classi-fied and evaluated. Results In the 266 cases of adverse drug reactions, there were more men than women, the ratio was 1∶0. 8;115 cases of adverse reactions were patients over the age of 60 ( 43. 23%) . The antimicrobial's incidence of adverse drug reactions was the highest, followed by anticancer drugs. The main route of administration was by intravenous infusion, the clinical manifestations of adverse reactions was skin and its appendages, followed by the digestive system, blood system and body damage, accounted for 31. 20% , 30. 83%, 9. 77%, 9. 77% respectively; serious adverse reactions 15 cases ( 5. 64% ) . Conclusion It is necessary to further strengthen the monitoring of adverse drug reactions, increase publicity efforts on adverse drug reactions, pay more attention to the monitoring of ad-verse reactions of antibiotics and anticancer drugs, in order to avoid the

  12. Torsadogenic Risk of Antipsychotics: Combining Adverse Event Reports with Drug Utilization Data across Europe

    OpenAIRE

    Raschi, Emanuel; Poluzzi, Elisabetta; Godman, Brian; Koci, Ariola; Moretti, Ugo; Kalaba, Marija; Bennie, Marion; Barbui, Corrado; Wettermark, Bjorn; Sturkenboom, Miriam; De Ponti, Fabrizio

    2013-01-01

    Background Antipsychotics (APs) have been associated with risk of torsade de Pointes (TdP). This has important public health implications. Therefore, (a) we exploited the public FDA Adverse Event Reporting System (FAERS) to characterize their torsadogenic profile; (b) we collected drug utilization data from 12 European Countries to assess the population exposure over the 2005-2010 period. Methods FAERS data (2004-2010) were analyzed based on the following criteria: (1) ≥4 cases of TdP/QT abno...

  13. Mixed-effects Poisson regression analysis of adverse event reports: The relationship between antidepressants and suicide

    OpenAIRE

    Gibbons, Robert D.; Segawa, Eisuke; Karabatsos, George; Amatya, Anup K.; Bhaumik, Dulal K.; Brown, C Hendricks; Kapur, Kush; Marcus, Sue M.; Hur, Kwan; Mann, J. John

    2008-01-01

    A new statistical methodology is developed for the analysis of spontaneous adverse event (AE) reports from post-marketing drug surveillance data. The method involves both empirical Bayes (EB) and fully Bayes estimation of rate multipliers for each drug within a class of drugs, for a particular AE, based on a mixed-effects Poisson regression model. Both parametric and semiparametric models for the random-effect distribution are examined. The method is applied to data from Food and Drug Adminis...

  14. Toxic epidermal necrolysis caused by acetaminophen featuring almost 100% skin detachment: Acetaminophen is associated with a risk of severe cutaneous adverse reactions.

    Science.gov (United States)

    Watanabe, Hideaki; Kamiyama, Taisuke; Sasaki, Shun; Kobayashi, Kae; Fukuda, Kenichiro; Miyake, Yasufumi; Aruga, Tohru; Sueki, Hirohiko

    2016-03-01

    Toxic epidermal necrolysis (TEN) is an adverse reaction that can be induced by various drugs; the associated mortality rate is 20-25%. A previous report showed a weak association between TEN and acetaminophen. Recently, the US Food and Drug Administration declared that acetaminophen is associated with a risk of serious skin reactions, including TEN. Here, we describe the case of a 43-year-old Japanese woman with TEN caused by acetaminophen. She had poorly controlled ulcerative colitis and was treated with high doses of prednisolone, infliximab, acetaminophen and lansoprazole. Nine days after administrating acetaminophen, targetoid erythematous and bullous lesions appeared on the patient's trunk, palms and the soles of her feet. The skin lesions expanded rapidly; within 3 weeks, skin detachment was detected across nearly 100% of the patient's body. However, no mucosal involvement of the eyes, oral cavity or genitalia was found. We performed lymphocyte transformation tests using various drugs; however, a high stimulation index was obtained only with acetaminophen. The patient recovered following treatment with plasmapheresis, i.v. immunoglobulin therapy, topical medication and supportive therapy. Acetaminophen is included in many prescription and over-the-counter products; thus, clinicians should monitor their patients for severe drug reactions, including TEN. PMID:26362011

  15. Reacciones adversas ocasionadas por los biomateriales usados en prostodoncia Adverse reactions caused by biomaterials used in prosthodontics

    Directory of Open Access Journals (Sweden)

    D.P. Restrepo Ospina

    2010-02-01

    Full Text Available La incidencia de reacciones adversas a los productos dentales es difícil de estimar. Los odontólogos usan productos potencialmente alérgicos e irritantes durante sus procedimientos dentales. Estos materiales incluyen antisépticos, anestésicos locales, radiación ultravioleta, guantes de látex, dique de goma, enjuagues y otros productos empleados en la higiene bucal. Adicionalmente, los materiales empleados durante los procedimientos restauradores como metales, materiales de impresión, cementos, acrílicos y adhesivos también pueden producir efectos indeseables en los tejidos de los pacientes. La presentación de complicaciones orales producidas por estos materiales pueden incluir estomatitis, reacciones liquenoides, quemaduras bucales, queilitis, inflamación labial y facial, sintomatología general y anafilaxis.The incidence of adverse reactions to dental products is difficult to estimate. Dentists use many potential allergens and irritants in the course of their work. These materials include antiseptics, local anaesthetics, ultraviolet radiation, latex gloves, rubber dams, mouthwashes and other dental hygiene materials. Besides, the materials used during the restorative procedures as metals, impression materials, cements, acrylics, and adhesives can also produce undesirable effects in the tissues of patients. The presentation of oral complaints can include stomatitis, lichenoid reactions, burning in the mouth, cheilitis and lip swelling, facial swelling, general symptoms and anaphylaxis.

  16. Cutaneous adverse drug reactions: clinical pattern and causative agents--a 6 year series from Chandigarh, India.

    Directory of Open Access Journals (Sweden)

    Sharma V

    2001-04-01

    Full Text Available AIM: To study the different clinical spectrum of cutaneous adverse drug reactions (ADR and to determine the causative drugs. MATERIALS & METHODS: A prospective, hospital based study was carried out over a period of 6 years recording various cutaneous ADR. RESULTS: A total of 500 patients with cutaneous ADR were enrolled in the study. The most common types of cutaneous ADR patterns were maculopapular rash (34.6%, fixed drug eruption (FDE (30% and urticaria (14%. The drugs most often incriminated for the various cutaneous ADR were antimicrobials (42.6%, anticonvulsants (22.2% and NSAIDs (18%. Anticonvulsants were implicated in 41.6% of maculopapular rashes. Sulfonamides accounted for 43.3% and NSAIDs for 30.7% of FDE. Urticaria was caused mainly by NSAIDs(24.3% and penicillins(20%. Anticonvulsants were responsible for 43.8% of life-threatening toxic epidermal necrolysis and Stevens Johnson syndrome. CONCLUSIONS: The clinical pattern and drugs causing cutaneous ADR are similar to those observed in other countries except for minor variations. Cutaneous ADR patterns and the drugs causing various reactions are changing every year, which may be due to the emergence of newer molecules and changing trends in the use of drugs.

  17. Acute renal pain as an adverse reaction of the rabies immunization

    Directory of Open Access Journals (Sweden)

    Lalošević Dušan

    2009-01-01

    Full Text Available Introduction. HRIG is the best preparate in rabies prophylaxis, and it's considered that optimal dose is 20 international units per kilogram and must not been reduced or overdosed. HRIG have to be injected infiltrative around bite wounds, and if after that remains a part of the dose, it has to be given in gluteal muscle. Application only in gluteus is vitium artis. Case report. At one patient immunized against rabies has occured acute bilateral renal pain and fever at time of immunization against rabies, and because of that vaccination must been stopped after the 3rd dose of vaccine. Patient was a 26-year-old female without significant pre-existing disease, bitten by stray dog. After the start of immunization, because the wrong direction, she received about 2.5 more amount of human rabies immunoglobuline (HRIG then is recommended on declaration at etiquette of ampoule, and only in gluteus in quantity of 10.5 ml. Discussion. Glomerulonephritis after rabies vaccination until now was described just once by Singhal et al. in 1981. year. Acute renal pain, after rabies vaccine, which aggravated after repeated vaccine doses in our patient who received overdosed HRIG, may be explained by immunopathological mechanism, rather with formation of circulating immune complexes, their precipitation on the glomerular basement membrane and developing glomerulonephritis. Conclusion. Low weight soluble molecular immune complexes formed when antigen is in excess, as in case after repeated doses of rabies vaccine, circulate and precipitate on glomerular membrane and causes glomerulonephritis. As contribution to this explanation, is that symptoms as renal pain disappeared after interrupting vaccination protocol in our patient.

  18. Allergic reaction related to ramipril use: a case report

    Directory of Open Access Journals (Sweden)

    Alencar Renata C

    2010-01-01

    Full Text Available Abstract Background Angiotensin-converting enzyme (ACE inhibitors are widely prescribed for patients with diabetes as a nephroprotector drug or to treat hypertension. Generally they are safe for clinical practice, but the relationship between these drugs and angioedema is known. The exact mechanism for ACE inhibitors-induced angioedema is not clear and it is still a matter of discussion. Case Report We reported a case of a 23-year-old black female with an 11 year history of type 1 diabetes, regularly monitored in the department of diabetes, in use of 0,98 UI/kg/day of human insulin, which presented an allergic reaction 24 h after ramipril use. The drug had been prescribed to treat diabetic nephropathy. There was no previous history of drug induced or alimentary allergy. The patient was instructed to discontinue the use of ramipril and oral antihistaminic drug and topical corticosteroid were prescribed. Skin biopsies were performed and confirmed the clinical hypothesis of pharmacodermy. The evaluation of ACE polymorphism identified DD genotype. Six months after the withdrawal of ramipril the patient was prescribed the angiotensin-II receptor blocker (ARB losartan as nephroprotector. She remained well without adverse reactions. Conclusions ACE inhibitors-induced angioedema is uncommon and the clinical presentation is variable with lips, tongue, oropharinge, and larynge as the most common locations. The presence of angioedema during treatment requires the immediate cessation of treatment due to the risk of possible severe complications. The case reported presented moderate symptoms, with the development of early onset edema in uncommon regions. ACE DD genotype had been associated with angioedema-ACE inhibitors induced. In patients who have experienced ACE inhibitor-related angioedema, ARB should be used cautiously used. However in the case of our patient, the prescription of losartan as nefroprotector did not result in any recurrent adverse effect.

  19. Methadone adverse reaction presenting with large increase in plasma methadone binding: a case series

    Directory of Open Access Journals (Sweden)

    Flockhart David A

    2011-10-01

    Full Text Available Abstract Introduction The use of methadone as an analgesic is on the increase, but it is widely recognized that the goal of predictable and reproducible dosing is confounded by considerable variability in methadone pharmacokinetics, and unpredictable side effects that include sedation, respiratory depression and cardiac arrhythmias. The mechanisms underlying these unpredictable effects are frequently unclear. Here, to the best of our knowledge we present the first report of an association between accidental methadone overexposure and increased plasma protein binding, a new potential mechanism for drug interactions with methadone. Case presentation We describe here the cases of two patients who experienced markedly different responses to the same dose of methadone during co-administration of letrozole. Both patients were post-menopausal Caucasian women who were among healthy volunteers participating in a clinical trial. Under the trial protocol both patients received 6 mg of intravenous methadone before and then after taking letrozole for seven days. One woman (aged 59 experienced symptoms consistent with opiate overexposure after the second dose of methadone that were reversed by naloxone, while the other (aged 49 did not. To understand the etiology of this event, we measured methadone pharmacokinetics in both patients. In our affected patient only, a fourfold to eightfold increase in methadone plasma concentrations after letrozole treatment was observed. Detailed pharmacokinetic analysis indicated no change in metabolism or renal elimination in our patient, but the percentage of unbound methadone in the plasma decreased 3.7-fold. As a result, the volume of distribution of methadone decreased approximately fourfold. The increased plasma binding in our affected patient was consistent with observed increases in plasma protein concentrations. Conclusions The marked increase in the total plasma methadone concentration observed in our patient, and

  20. An analysis of prescription pattern and adverse drug reaction profile in children treated with antiepileptic drugs in a tertiary care teaching hospital

    OpenAIRE

    Meenakshi B.; Ezhil Ramya J.; Ananthy Shri T. R. R.

    2016-01-01

    Background: Epilepsy is a clinical diagnosis made after a child has had two (or) more unprovoked seizures. Ideal goal in the management of childhood epilepsy is complete control with minimal side effects. The incidence of adverse effects is an important issue with antiepileptic drugs (AEDs). We took up this study to analyse the pattern of AEDs prescribed and adverse drug reaction (ADR) profile in children with epilepsy being treated at a tertiary care Teaching hospital of South Tamil Nadu. ...

  1. 羟苯酯类防腐剂的不良反应%Adverse Drug Reactions Induced by Parabens Used as Preservatives

    Institute of Scientific and Technical Information of China (English)

    李中东; 张云轩; 郭燕萍; 施孝金; 钟明康

    2012-01-01

    Objective To review the adverse drug reactions induced by parabens when used as preservatives. Methods A simple conclusion on adverse drug reactions induced by parabens was carried out by reviewing the related references. Results Parabens are the most commonly used preservatives. Parabens are likely to cause adverse reactions as allergic reactions, cross reactions and estrogenic activity, paraben paradox can also be observed. Conclusion Professional clinicians must pay high attention to the adverse reactions of parabens contained in the pharmaceutical products and use them rationally as possible as they can.%目的 综述羟苯酯类防腐剂不良反应.方法 参阅国外相关文献,总结羟苯酯类的不良反应.结果 羟苯酯类是最常用的防腐剂,不良反应表现为过敏、交叉反应和激素效应,会发生“羟苯酯类悖论”现象.结论 医务人员使用含羟苯酯类的制剂处方时,要重视它的不良反应,做到合理运用.

  2. Phenobarbitone induced drug reaction with eosinophilia and systemic symptoms (DRESS: a case report

    Directory of Open Access Journals (Sweden)

    Navreet K. Natt

    2013-06-01

    Full Text Available Drug reaction with eosinophilia and systemic symptoms (DRESS is a life threatening cutaneous drug reaction with visceral involvement and hematological abnormalities. Being a rare side effect, it is often under-reported and misdiagnosed. The fatal adverse drug reaction is associated most commonly with aromatic anti-epileptics phenytoin, carbamazepine and less frequently with phenobarbitone. Here, we report a case of phenobarbitone induced DRESS in a 1 year old male child. He succumbed to fulminant hepatic failure inspite of being put on steroids, hepatoprotectives, antibiotics and ventilatory support. [Int J Basic Clin Pharmacol 2013; 2(3.000: 333-335

  3. ToxAlerts: a Web server of structural alerts for toxic chemicals and compounds with potential adverse reactions.

    Science.gov (United States)

    Sushko, Iurii; Salmina, Elena; Potemkin, Vladimir A; Poda, Gennadiy; Tetko, Igor V

    2012-08-27

    The article presents a Web-based platform for collecting and storing toxicological structural alerts from literature and for virtual screening of chemical libraries to flag potentially toxic chemicals and compounds that can cause adverse side effects. An alert is uniquely identified by a SMARTS template, a toxicological endpoint, and a publication where the alert was described. Additionally, the system allows storing complementary information such as name, comments, and mechanism of action, as well as other data. Most importantly, the platform can be easily used for fast virtual screening of large chemical datasets, focused libraries, or newly designed compounds against the toxicological alerts, providing a detailed profile of the chemicals grouped by structural alerts and endpoints. Such a facility can be used for decision making regarding whether a compound should be tested experimentally, validated with available QSAR models, or eliminated from consideration altogether. The alert-based screening can also be helpful for an easier interpretation of more complex QSAR models. The system is publicly accessible and tightly integrated with the Online Chemical Modeling Environment (OCHEM, http://ochem.eu). The system is open and expandable: any registered OCHEM user can introduce new alerts, browse, edit alerts introduced by other users, and virtually screen his/her data sets against all or selected alerts. The user sets being passed through the structural alerts can be used at OCHEM for other typical tasks: exporting in a wide variety of formats, development of QSAR models, additional filtering by other criteria, etc. The database already contains almost 600 structural alerts for such endpoints as mutagenicity, carcinogenicity, skin sensitization, compounds that undergo metabolic activation, and compounds that form reactive metabolites and, thus, can cause adverse reactions. The ToxAlerts platform is accessible on the Web at http://ochem.eu/alerts, and it is constantly

  4. Systematic drug safety evaluation based on public genomic expression (Connectivity Map) data: Myocardial and infectious adverse reactions as application cases

    International Nuclear Information System (INIS)

    Adverse drug reaction (ADR) is of great importance to both regulatory agencies and the pharmaceutical industry. Various techniques, such as quantitative structure–activity relationship (QSAR) and animal toxicology, are widely used to identify potential risks during the preclinical stage of drug development. Despite these efforts, drugs with safety liabilities can still pass through safety checkpoints and enter the market. This situation raises the concern that conventional chemical structure analysis and phenotypic screening are not sufficient to avoid all clinical adverse events. Genomic expression data following in vitro drug treatments characterize drug actions and thus have become widely used in drug repositioning. In the present study, we explored prediction of ADRs based on the drug-induced gene-expression profiles from cultured human cells in the Connectivity Map (CMap) database. The results showed that drugs inducing comparable ADRs generally lead to similar CMap expression profiles. Based on such ADR-gene expression association, we established prediction models for various ADRs, including severe myocardial and infectious events. Drugs with FDA boxed warnings of safety liability were effectively identified. We therefore suggest that drug-induced gene expression change, in combination with effective computational methods, may provide a new dimension of information to facilitate systematic drug safety evaluation. - Highlights: • Drugs causing common toxicity lead to similar in vitro gene expression changes. • We built a model to predict drug toxicity with drug-specific expression profiles. • Drugs with FDA black box warnings were effectively identified by our model. • In vitro assay can detect severe toxicity in the early stage of drug development

  5. Systematic drug safety evaluation based on public genomic expression (Connectivity Map) data: Myocardial and infectious adverse reactions as application cases

    Energy Technology Data Exchange (ETDEWEB)

    Wang, Kejian, E-mail: kejian.wang.bio@gmail.com [Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, Shanghai (China); Weng, Zuquan [Japan National Institute of Occupational Safety and Health, Kawasaki (Japan); Sun, Liya [Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, Shanghai (China); Sun, Jiazhi; Zhou, Shu-Feng [Department of Pharmaceutical Sciences, College of Pharmacy, University of South Florida, Tampa, FL (United States); He, Lin, E-mail: helin@Bio-X.com [Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, Shanghai (China)

    2015-02-13

    Adverse drug reaction (ADR) is of great importance to both regulatory agencies and the pharmaceutical industry. Various techniques, such as quantitative structure–activity relationship (QSAR) and animal toxicology, are widely used to identify potential risks during the preclinical stage of drug development. Despite these efforts, drugs with safety liabilities can still pass through safety checkpoints and enter the market. This situation raises the concern that conventional chemical structure analysis and phenotypic screening are not sufficient to avoid all clinical adverse events. Genomic expression data following in vitro drug treatments characterize drug actions and thus have become widely used in drug repositioning. In the present study, we explored prediction of ADRs based on the drug-induced gene-expression profiles from cultured human cells in the Connectivity Map (CMap) database. The results showed that drugs inducing comparable ADRs generally lead to similar CMap expression profiles. Based on such ADR-gene expression association, we established prediction models for various ADRs, including severe myocardial and infectious events. Drugs with FDA boxed warnings of safety liability were effectively identified. We therefore suggest that drug-induced gene expression change, in combination with effective computational methods, may provide a new dimension of information to facilitate systematic drug safety evaluation. - Highlights: • Drugs causing common toxicity lead to similar in vitro gene expression changes. • We built a model to predict drug toxicity with drug-specific expression profiles. • Drugs with FDA black box warnings were effectively identified by our model. • In vitro assay can detect severe toxicity in the early stage of drug development.

  6. ADVERSE EVENT REPORTING FOR A DERMATOPHARMACOKINETIC STUDY OF DICLOFENAC SODIUM TOPICAL FORMULATIONS

    Directory of Open Access Journals (Sweden)

    Mayee Rahul

    2011-09-01

    Full Text Available In this single-dose-one arm, open label three way parallel design, pharmacokinetic study of three marketed formulations of Diclofenac Sodium using 12 healthy Indian male subjects, the pharmacokinetic parameters of three marketed Diclofenac Sodium topical formulations were compared. Marketed Diclofenac Sodium topical formulations (A, B & C were applied on the pre-marked forearms of the subjects as per the dosing schedule. Treatment sample C was used as a reference sample. Subjects received treatment A, treatment B & treatment C on both the arms simultaneously, following open label three way parallel design. Skin Stratum Corneum samples were collected in sterile glass test tubes during the study period. The samples were collected pre-dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, & 6.0 hours post-dose application. Diclofenac Sodium was estimated in Stratum Corneum using a validated Spectroscopic method and the treatments were claimed to be bio-equivalent.The aim of this article was to report the occurrence of adverse events during this study. It was observed that only a single incidence of mild adverse event was reported in two volunteers, and it involved mild laceration on the right forearm. But, the event was found to be self resolving & with the relationship of the adverse event to study medication was “unlikely” but it could be due to the ‘tape stripping method’ employed for DPK analysis.

  7. Analysis of 156 cases of Levofloxacin adverse reactions%156例左氧氟沙星不良反应案例分析

    Institute of Scientific and Technical Information of China (English)

    姜仁风; 徐作国

    2014-01-01

    目的:通过对左氧氟沙星注射液的不良反应案例分析,为临床安全用药提供参考。方法:选取近6年二、三级医院药品不良反应案例资料121例,和近几年有关医学杂志报道案例35例进行统计综合分析。结果:左氧氟沙星注射液不良反应累及8大系统的器官,涉及23种表现。以皮肤及附属器官、消化系统、循环系统不良反应居多。结论:左氧氟沙星注射液不良反应以皮肤及附属器、消化系统和循环系统累及居多。%Objective:To investigate Levofloxacin adverse reactions/ events, and provide a reference for clinical safe medica-tion. Methods:A comprehensive statistical analysis was performed on 121 cases of Levofloxacin adverse reactions/ events in second-class hospitals and third-class hospitals in recent 6 years and 35 published cases of Levofloxacin adverse reactions/ events in medical journals in recent years. Results: Levofloxacin adverse reactions/ events involved eight major systems and organs and had 23 kinds of performance. Skin and its appendages, digestive system, and circulatory system had the most adverse reactions. Conclusions: Levo-floxacin adverse reaction/ event occur in the skin and its appendages, digestive system, and circulatory system mostly.

  8. Statistical Mining of Potential Drug Interaction Adverse Effects in FDA's Spontaneous Reporting System.

    Science.gov (United States)

    Harpaz, Rave; Haerian, Krystl; Chase, Herbert S; Friedman, Carol

    2010-01-01

    Many adverse drug effects (ADEs) can be attributed to drug interactions. Spontaneous reporting systems (SRS) provide a rich opportunity to detect novel post-marketed drug interaction adverse effects (DIAEs), as they include populations not well represented in clinical trials. However, their identification in SRS is nontrivial. Most existing research have addressed the statistical issues used to test or verify DIAEs, but not their identification as part of a systematic large scale database-wide mining process as discussed in this work. This paper examines the application of a highly optimized and tailored implementation of the Apriori algorithm, as well as methods addressing data quality issues, to the identification of DIAEs in FDAs SRS. PMID:21346985

  9. Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax) in the Vaccine Adverse Event Reporting System (VAERS) in the United States, 1990‒2015

    Science.gov (United States)

    Moro, Pedro L.; Woo, Emily Jane; Paul, Wendy; Lewis, Paige; Petersen, Brett W.; Cano, Maria

    2016-01-01

    Background In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use in the United States. Objective To assess adverse events (AEs) after HDCV reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. Methods We searched VAERS for US reports after HDCV among persons vaccinated from January 1, 1990–July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barré syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using MedDRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV. Results VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination. Conclusions This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies. PMID:27410239

  10. Patient-reported health as a prognostic factor for adverse events following percutaneous coronary intervention

    Directory of Open Access Journals (Sweden)

    Biering K

    2014-01-01

    Full Text Available Karin Biering,1 Hans Erik Bøtker,2 Troels Niemann,3 Niels Henrik Hjollund4,51Department of Occupational Medicine, Regional Hospital West Jutland, Herning, 2Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, 3Department of Cardiology, Regional Hospital West Jutland, Herning, 4WestChronic, Regional Hospital West Jutland, Herning, 5Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, DenmarkObjective: A relation may exist between self-reported health and adverse events in coronary heart disease. Previous studies have been vulnerable to possible selection bias. In the study reported here, we examined the association between self-rated health and adverse events in terms of cardiac events, cardiac readmissions, and all-cause mortality in a complete cohort of patients treated with percutaneous coronary intervention (PCI.Study design and setting: A cohort of patients with coronary heart disease treated with PCI was followed up with questionnaires 4 weeks after PCI to measure self-rated health and in registers to identify adverse events. Of 1,752 eligible patients under 67 years, 26 died during the first 4 weeks. A total of 224 patients were excluded from the analysis because they were readmitted with a cardiac diagnosis before answering the first questionnaire. We received complete SF-12 Health Survey component summaries from 984 of the remaining 1,502 patients. We used multiple imputation to establish a complete cohort, including nonrespondents.Results: During follow-up, 83 patients died, 220 patients experienced a new cardiac event, and 526 patients experienced a hospital readmission related to coronary heart disease. Poor self-rated health was related to cardiac events, cardiac readmission, and all-cause mortality. The associations were stronger for all-cause mortality than for events and readmissions. Physical health was more important than mental health, but both revealed an exposure–response pattern

  11. 磷酸奥司他韦预防甲型H1N1流感时引起不良反应206例报道%Report of 206 cases of adverse drug reactions in using oseltamivir to prevent influenza A H1N1 influenza

    Institute of Scientific and Technical Information of China (English)

    董伟; 王艳彩

    2011-01-01

    AIM To analyse the adverse drug reactions (ADRs) occurred in people who took oseltamivir phosphate to prevent influenza A H1N1 influenza. METHODS The ADRs of 2 978 cases who took oseltamivir phosphate 75 mg once daily for 7 d to prevent influenza A H1N1 influenza were recorded every day and 2 790 cases with intact data were carried out statistical analysis. RESULTS There were 206 cases of ADRs, with the total ADRs incidence rate of 7.38%. Cases with the main clinical manifestations of enteron symptoms such as diarrhea, nausea, and bellyache etc.were 157, with the incidence rate of 5.62%. The incidenec rate of ADRs was low in rash, otalgia, tachycardia, foreign body sensation of esophagus and nosebleed and insomnia etc. CONCLUSION The ADRs of oseltamivir phosphate in the prevention of influenza A HIN1 influenza mainly were enteron symptoms which do not affect the treatment in general. But if such symptoms as rash or tachyeardia occur, the drug should be immediately stopped and symptomatic treatment must be given.%目的 分析磷酸奥司他韦预防甲型H1N1流感时人群不良反应发生情况.方法 对2978例服用磷酸奥司他韦75㎎,qd,共7 d预防甲型H1N1型流感者逐日记录其不良反应并将2790例资料完整者进行分析统计.结果 206例出现不良反应,总不良反应发生率为7.38%,以腹泻、恶心、腹痛等消化道症状为主,共157例,发生率为5.62%.皮疹、耳痛、心动过速、食管异物感、鼻出血、失眠等发生率低.结论 磷酸奥司他韦预防甲型H1N1流感时不良反应以消化道症状为主,一般不影响治疗.如出现皮疹、心动过速等应停药并给予对症处理.

  12. 探讨眼底血管荧光造影的不良反应分析%Analysis of Adverse Reactions in Fundus Fluorescein Angiography

    Institute of Scientific and Technical Information of China (English)

    陶屹

    2016-01-01

    目的:本次主要对眼底血管荧光造影的不良反应进行分析,为临床检查提供重要依据,确保降低或避免患者出现不良反应。方法选取2015年7月~2016年5月我院收治的210例眼底荧光血管造影室行造影的患者,其中有80例患者出现不良反应,并分析80例患者不良反应发生的原因。结果患者主要为Ⅰ度不良反应情况为最多,且以恶心最多,未出现Ⅲ度和死亡的患者,男性的不良反应发生率高于女性,P<0.05。结论在进行造影前,医护人员应当加强询患者是否伴有其他基础疾病、是否过敏等情况,同时需要在造影室准备好急救的药物,在患者造影后,医护人员需要嘱咐患者留院观察30 min左右,以确保患者无不良反应才可离开。%Objective To analyze the adverse reactions of fundus lfuorescein angiography in order to provide an important basis for clinical examination, to ensure that patients with adverse reactions to reduce or avoid adverse reactions.Methods 210 cases of patients with fundus lfuorescein angiography were selected from July 2015 to May 2016 in our hospital, including 80 cases of adverse reactions, and analysis of the causes of adverse reactions in 80 patients.Results The main adverse reactions of patients withⅠ degree was the most, and the most nausea, noⅢ degree and death of patients, the incidence of adverse reactions of men was higher than women,P<0.05.Conclusion In contrast, doctors and nurses should strengthen consultation patients is associated with other diseases, allergies and other conditions, also need to prepare emergency medicine in ventricular angiography. After angiography and medical staff need to asked the patients stay in hospital for observation for about 30 minutes, to ensure that patients with no adverse reaction before leaving.

  13. 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.

  14. Delayed immune mediated adverse effects to hyaluronic acid fillers: report of five cases and review of the literature

    Directory of Open Access Journals (Sweden)

    Ora Bitterman-Deutsch

    2015-03-01

    Full Text Available Hyaluronic acid (HA fillers in cosmetic medicine have been considered relatively safe, though fillers used in European countries and throughout the world are not necessarily approved by the Food and Drug Administration. As their use continues to expand worldwide, physicians in a wide range of medical specialties are authorized to perform HA injections, including general medicine practitioners and even dentists. An increasing number of reports have appeared regarding side effects to these products. It is now known that reactions to Hyaluronic acid are related not only to technical faults of the injections, but also to immune responses, including delayed hypersensitivity and granulomatous reactions. Herein, we describe five cases treated by a variety of treatment modalities, all with delayed reactions to different brands of hyaluronic acid fillers. As there is currently no standardization of treatment options of adverse effects, these cases accentuate the debate regarding the approach to the individual patient and the possible need for pre-testing in patients with an atopic tendency.

  15. Three-dimensional drip infusion CT cholangiography in patients with suspected obstructive biliary disease: a retrospective analysis of feasibility and adverse reaction to contrast material.

    Directory of Open Access Journals (Sweden)

    Smedby Ö

    2006-04-01

    Full Text Available Abstract Background Computed Tomography Cholangiography (CTC is a fast and widely available alternative technique to visualise hepatobiliary disease in patients with an inconclusive ultrasound when MRI cannot be performed. The method has previously been relatively unknown and sparsely used, due to concerns about adverse reactions and about image quality in patients with impaired hepatic function and thus reduced contrast excretion. In this retrospective study, the feasibility and the frequency of adverse reactions of CTC when using a drip infusion scheme based on bilirubin levels were evaluated. Methods The medical records of patients who had undergone upper abdominal spiral CT with subsequent three-dimensional rendering of the biliary tract by means of CTC during seven years were retrospectively reviewed regarding serum bilirubin concentration, adverse reaction and presence of visible contrast media in the bile ducts at CT examination. In total, 153 consecutive examinations in 142 patients were reviewed. Results Contrast media was observed in the bile ducts at 144 examinations. In 110 examinations, the infusion time had been recorded in the medical records. Among these, 42 examinations had an elevated bilirubin value (>19 umol/L. There were nine patients without contrast excretion; 3 of which had a normal bilirubin value and 6 had an elevated value (25–133 umol/L. Two of the 153 examinations were inconclusive. One subject (0.7% experienced a minor adverse reaction – a pricking sensation in the face. No other adverse effects were noted. Conclusion We conclude that drip infusion CTC with an infusion rate of the biliary contrast agent iotroxate governed by the serum bilirubin value is a feasible and safe alternative to MRC in patients with and without impaired biliary excretion. In this retrospective study the feasibility and the frequency of adverse reactions when using a drip infusion scheme based on bilirubin levels has been evaluated.

  16. Three-dimensional drip infusion CT cholangiography in patients with suspected obstructive biliary disease: a retrospective analysis of feasibility and adverse reaction to contrast material

    International Nuclear Information System (INIS)

    Computed Tomography Cholangiography (CTC) is a fast and widely available alternative technique to visualise hepatobiliary disease in patients with an inconclusive ultrasound when MRI cannot be performed. The method has previously been relatively unknown and sparsely used, due to concerns about adverse reactions and about image quality in patients with impaired hepatic function and thus reduced contrast excretion. In this retrospective study, the feasibility and the frequency of adverse reactions of CTC when using a drip infusion scheme based on bilirubin levels were evaluated. The medical records of patients who had undergone upper abdominal spiral CT with subsequent three-dimensional rendering of the biliary tract by means of CTC during seven years were retrospectively reviewed regarding serum bilirubin concentration, adverse reaction and presence of visible contrast media in the bile ducts at CT examination. In total, 153 consecutive examinations in 142 patients were reviewed. Contrast media was observed in the bile ducts at 144 examinations. In 110 examinations, the infusion time had been recorded in the medical records. Among these, 42 examinations had an elevated bilirubin value (>19 umol/L). There were nine patients without contrast excretion; 3 of which had a normal bilirubin value and 6 had an elevated value (25–133 umol/L). Two of the 153 examinations were inconclusive. One subject (0.7%) experienced a minor adverse reaction – a pricking sensation in the face. No other adverse effects were noted. We conclude that drip infusion CTC with an infusion rate of the biliary contrast agent iotroxate governed by the serum bilirubin value is a feasible and safe alternative to MRC in patients with and without impaired biliary excretion. In this retrospective study the feasibility and the frequency of adverse reactions when using a drip infusion scheme based on bilirubin levels has been evaluated

  17. Analysis of the Causes of Senecio Scandens Clinical Adverse Reactions%千里光临床不良反应成因分析

    Institute of Scientific and Technical Information of China (English)

    尹利顺; 李晓宇; 孙蓉

    2015-01-01

    目的:分析千里光发生临床不良反应的原因,为进一步安全性评价提供文献依据和研究思路。方法通过近十多年来国内外相关文献对千里光临床不良反应的报道,进行整理、分析与归纳。结果千里光主要临床不良反应为肝脏损伤,其发生与长期使用、使用剂量、品种混用、配伍使用、制备工艺和个体差异等原因有关,尤其是长期服用是千里光致肝损伤、甚至产生死亡的主要原因;千里光所含的吡咯里西啶类生物碱(pyrrolizidine alkaloids, PAs)是导致肝毒性的主要物质基础。结论针对千里光临床不良反应,应亟待加强千里光药材及其中成药中肝损伤毒性规律和物质基础研究,进而通过明晰肝毒物质基础的体内过程和“TD-TK”关联评价,制订体内安全限度,完善并提高质量标准,保证临床用药安全。%Objective To review the research status of Senecio scandens clinical adverse reactions, in order to offer accordance and study ideas for further safety evaluation. Methods References in the last decades at home and abroad about Senecio scandens clinical reports of adverse reactions were collated, analyzed and summarized. Results The most serious adverse reaction of Senecio scandens is hepatotoxicity, which is related to the long-term use, dosage, a mixture of varieties, compatibility, preparation technology and the difference of individual, and especially long-term use is the main cause of death of clinical cases. Studies have shown that pyrrolizidine alkaloids (PAs) contained in Senecio scandens are the main material basis of hepatotoxicity. Conclusion For the causes of Senecio scandens clinical adverse reactions, the hepatotoxicity damage regularity and material basis of Senecio scandens and its Chinese traditional patent medicine should be urgently studied, and intracorporal process of toxic substances and "toxicodynamics-toxicokinetics" relevance

  18. Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA.

    Science.gov (United States)

    Eriksson, Robert; Aagaard, Lise; Jensen, Lars Juhl; Borisova, Liza; Hørlück, Dorte; Brunak, Søren; Hansen, Ebba Holme

    2014-06-01

    Pharmaceutical product information (PI) supplied by the regulatory authorities serves as a source of information on safe and effective use of drugs. The objectives of this study were to qualitatively and quantitatively compare PIs for selected drugs marketed in both Denmark and the USA with respect to consistency and discrepancy of listed adverse drug reaction (ADR) information. We compared individual ADRs listed in PIs from Denmark and the USA with respect to type and frequency. Consistency was defined as match of ADRs and of ADR frequency or match could not be ruled out. Discrepancies were defined as ADRs listed only in one country or listed with different frequencies. We analyzed PIs for 40 separate drugs from ten therapeutic groups and assigned the 4003 identified ADRs to System Organ Classes (Medical Dictionary for Regulatory Activities [MedDRA] terminology). Less than half of listed ADRs (n = 1874; 47%) showed consistency. Discrepancies (n = 2129; 53%) were split into ADRs listed only in the USA (n = 1558; 39%), ADRs listed only in Denmark (n = 325; 8%) and ADRs listed with different frequencies (n = 246; 6%). The majority of listed ADRs were of the type "gastrointestinal disorders" and "nervous system disorders". Our results show great differences in PIs for drugs approved in both Denmark and the USA illuminating concerns about the credibility of the publicly available PIs. The results also represent an argument for further harmonization across borders to improve consistency between authority-supplied information. PMID:25505588

  19. Factors affecting the development of adverse drug reactions to β-blockers in hospitalized cardiac patient population

    Science.gov (United States)

    Mugoša, Snežana; Djordjević, Nataša; Djukanović, Nina; Protić, Dragana; Bukumirić, Zoran; Radosavljević, Ivan; Bošković, Aneta; Todorović, Zoran

    2016-01-01

    The aim of the present study was to undertake a study on the prevalence of cytochrome P450 2D6 (CYP2D6) poor metabolizer alleles (*3, *4, *5, and *6) on a Montenegrin population and its impact on developing adverse drug reactions (ADRs) of β-blockers in a hospitalized cardiac patient population. A prospective study was conducted in the Cardiology Center of the Clinical Center of Montenegro and included 138 patients who had received any β-blocker in their therapy. ADRs were collected using a specially designed questionnaire, based on the symptom list and any signs that could point to eventual ADRs. Data from patients’ medical charts, laboratory tests, and other available parameters were observed and combined with the data from the questionnaire. ADRs to β-blockers were observed in 15 (10.9%) patients. There was a statistically significant difference in the frequency of ADRs in relation to genetically determined enzymatic activity (Phospitalization, CYP2D6 poor metabolizer phenotype, and the concomitant use of other CYP2D6-metabolizing drugs. Therefore, in hospitalized patients with polypharmacy CYP2D6 genotyping might be useful in detecting those at risk of ADRs.

  20. 78 FR 63221 - Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the...

    Science.gov (United States)

    2013-10-23

    ... the Federal Register of May 25, 2010 (75 FR 29352), FDA published the notice of availability for a... Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability AGENCY: Food and Drug... availability of a guidance for industry 188 entitled ``Data Elements for Submission of Veterinary Adverse...

  1. Adverse events associated with yoga: a systematic review of published case reports and case series.

    Directory of Open Access Journals (Sweden)

    Holger Cramer

    Full Text Available While yoga is gaining increased popularity in North America and Europe, its safety has been questioned in the lay press. The aim of this systematic review was to assess published case reports and case series on adverse events associated with yoga. Medline/Pubmed, Scopus, CAMBase, IndMed and the Cases Database were screened through February 2013; and 35 case reports and 2 case series reporting a total of 76 cases were included. Ten cases had medical preconditions, mainly glaucoma and osteopenia. Pranayama, hatha yoga, and Bikram yoga were the most common yoga practices; headstand, shoulder stand, lotus position, and forceful breathing were the most common yoga postures and breathing techniques cited. Twenty-seven adverse events (35.5% affected the musculoskeletal system; 14 (18.4% the nervous system; and 9 (11.8% the eyes. Fifteen cases (19.7% reached full recovery; 9 cases (11.3% partial recovery; 1 case (1.3% no recovery; and 1 case (1.3% died. As any other physical or mental practice, yoga should be practiced carefully under the guidance of a qualified instructor. Beginners should avoid extreme practices such as headstand, lotus position and forceful breathing. Individuals with medical preconditions should work with their physician and yoga teacher to appropriately adapt postures; patients with glaucoma should avoid inversions and patients with compromised bone should avoid forceful yoga practices.

  2. The drug efficacy and adverse reactions in a mouse model of oral squamous cell carcinoma treated with oxaliplatin at different time points during a day

    Directory of Open Access Journals (Sweden)

    Yang K

    2013-06-01

    Full Text Available Kai Yang,1,2 Ningbo Zhao,1 Dan Zhao,1,2 Dan Chen,1 Yadong Li1 1Department of Oral and Maxillofacial Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 2Chongqing Key Laboratory for Oral Diseases and Biomedical Sciences, Chongqing Medical University, Chongqing, People’s Republic of China Background: Recent studies have shown that the growth and proliferation of cancer cells in vivo exhibit circadian rhythm, and the efficacy and adverse reactions of platinum-based anticancer drugs administered at different times of the day vary significantly on colon cancer. However, since the circadian rhythms of growth and proliferation of various cancer cells often differ, the question of whether the administration of platinum anticancer drugs at different times of the day exerts significantly different efficacy and adverse effects on oral cancers remains to be elucidated. This study has compared the efficacy and adverse effects of oxaliplatin (L-OHP administration at different times during a day on oral squamous cell carcinoma in mice and has analyzed cellular circadian rhythms. Methods: The mouse model for oral squamous cell carcinoma was established in 75 nude mice, housed in a 12 hour light/12 hour dark cycle environment. The mice were randomly divided into five groups; four experimental groups were intravenously injected with L-OHP at four time points within a 24-hour period (4, 10, 16, and 22 hours after lights on [HALO]. The control group was intravenously injected with the same volume of saline. Treatment efficacy and adverse reactions were compared on the seventh day after the injection, at 22 HALO. The existence of circadian rhythms was determined by cosine analysis. Results: Only injections of L-OHP at 16 and 22 HALO significantly prolonged animal survival time. The adverse reactions in mice injected with L-OHP at 16 and 22 HALO were significantly less than those observed in mice administered L-OHP at 4 and 10 HALO

  3. The Impact of Experiencing Adverse Drug Reactions on the Patient's Quality of Life : A Retrospective Cross-Sectional Study in the Netherlands

    NARCIS (Netherlands)

    Rolfes, Leàn; van Hunsel, Florence; Taxis, Katja; van Puijenbroek, Eugène

    2016-01-01

    INTRODUCTION: There is little information as to what extent adverse drug reactions (ADRs) influence patients' health-related quality of life (HR-QOL). From a pharmacovigilance perspective, capturing and making the best use of this information remains a challenge. The Netherlands Pharmacovigilance Ce

  4. Common Clinical Adverse Reactions of Fluoroquinolones%氟喹诺酮类药物临床常见不良反应观察

    Institute of Scientific and Technical Information of China (English)

    孙耿先

    2015-01-01

    目的:对氟喹诺酮类药物在临床中常见的不良反应进行观察并对其成因进行分析,从而为临床诊疗用药提供更加科学的参考依据。方法以我院2013年2月~2014年2月60例采用氟喹诺酮类药物就诊的患者临床反应及由药品不良反应监测部门的采集数据为依据进行分析。结果采用氟喹诺酮类药物进行治疗的患者常见的临床不良反应主要包括中枢神经系统反应、皮肤过敏反应以及胃肠道反应,非常见药物不良反应有对泌尿系统、骨关节等造成的影响。结论根据对氟喹诺酮类药物的临床观察结果分析得出该类药物造成的不良反应较为普遍,因此临床医师应以合理、科学的原则进行用药最大程度避免临床不良反应发生的现象。%Objective To observe and analyze the causes of clinical common adverse reactions in fluoroquinolones,thereby providing a more scientific basis for clinical diagnosis and treatment medication. Methods In my hospital from February 2013 to February 2014 period,60 cases with clinical response of fluoroquinolones for treatment and adverse reaction monitoring data col ected by the pharmaceutical sector as a basis for analysis. Results Common clinical adverse reactions in patients using fluoroquinolone for treatment included the central nervous system reactions,al ergic skin reactions and gastrointestinal reactions,adverse drug reactions were uncommon effect on the urinary system,bone and joints caused. Conclusion Based on the analysis of fluoroquinolones in clinical observations obtained these drugs cause adverse reactions more common,so clinicians should be rational and scientific principles to avoid the phenomenon of drug maximize clinical adverse reactions occur.

  5. Prevalence and perceived preventability of self-reported adverse drug events--a population-based survey of 7099 adults.

    Directory of Open Access Journals (Sweden)

    Katja Marja Hakkarainen

    Full Text Available PURPOSE: Adverse drug events (ADEs are common and often preventable among inpatients, but self-reported ADEs have not been investigated in a representative sample of the general public. The objectives of this study were to estimate the 1-month prevalence of self-reported ADEs among the adult general public, and the perceived preventability of 2 ADE categories: adverse drug reactions (ADRs and sub-therapeutic effects (STEs. METHODS: In this cross-sectional study, a postal survey was sent in October 2010 to a random sample of 13 931 Swedish residents aged ≥ 18 years. Self-reported ADEs experienced during the past month included ADRs, STEs, drug dependence, drug intoxications and morbidity due to drug-related untreated indication. ADEs could be associated with prescription, non-prescription or herbal drugs. The respondents estimated whether ADRs and STEs could have been prevented. ADE prevalences in age groups (18-44, 45-64, or ≥65 years were compared. RESULTS: Of 7099 respondents (response rate 51.0%, ADEs were reported by 19.4% (95% confidence interval, 18.5-20.3%, and the prevalence did not differ by age group (p>0.05. The prevalences of self-reported ADRs, STEs, and morbidities due to drug-related untreated indications were 7.8% (7.2-8.4%, 7.6% (7.0-8.2% and 8.1% (7.5-8.7%, respectively. The prevalence of self-reported drug dependence was 2.2% (1.9-2.6%, and drug intoxications 0.2% (0.1-0.3%. The respondents considered 19.2% (14.8-23.6% of ADRs and STEs preventable. Although reported drugs varied between ADE categories, most ADEs were attributable to commonly dispensed drugs. Drugs reported for all and preventable events were similar. CONCLUSIONS: One-fifth of the adult general public across age groups reported ADEs during the past month, indicating a need for prevention strategies beyond hospitalised patients. For this, the underlying causes of ADEs should increasingly be investigated. The high burden of ADEs and preventable ADEs from

  6. Prevalence and Perceived Preventability of Self-Reported Adverse Drug Events – A Population-Based Survey of 7099 Adults

    Science.gov (United States)

    Hakkarainen, Katja Marja; Andersson Sundell, Karolina; Petzold, Max; Hägg, Staffan

    2013-01-01

    Purpose Adverse drug events (ADEs) are common and often preventable among inpatients, but self-reported ADEs have not been investigated in a representative sample of the general public. The objectives of this study were to estimate the 1-month prevalence of self-reported ADEs among the adult general public, and the perceived preventability of 2 ADE categories: adverse drug reactions (ADRs) and sub-therapeutic effects (STEs). Methods In this cross-sectional study, a postal survey was sent in October 2010 to a random sample of 13 931 Swedish residents aged ≥18 years. Self-reported ADEs experienced during the past month included ADRs, STEs, drug dependence, drug intoxications and morbidity due to drug-related untreated indication. ADEs could be associated with prescription, non-prescription or herbal drugs. The respondents estimated whether ADRs and STEs could have been prevented. ADE prevalences in age groups (18–44, 45–64, or ≥65 years) were compared. Results Of 7099 respondents (response rate 51.0%), ADEs were reported by 19.4% (95% confidence interval, 18.5–20.3%), and the prevalence did not differ by age group (p>0.05). The prevalences of self-reported ADRs, STEs, and morbidities due to drug-related untreated indications were 7.8% (7.2–8.4%), 7.6% (7.0–8.2%) and 8.1% (7.5–8.7%), respectively. The prevalence of self-reported drug dependence was 2.2% (1.9–2.6%), and drug intoxications 0.2% (0.1–0.3%). The respondents considered 19.2% (14.8–23.6%) of ADRs and STEs preventable. Although reported drugs varied between ADE categories, most ADEs were attributable to commonly dispensed drugs. Drugs reported for all and preventable events were similar. Conclusions One-fifth of the adult general public across age groups reported ADEs during the past month, indicating a need for prevention strategies beyond hospitalised patients. For this, the underlying causes of ADEs should increasingly be investigated. The high burden of ADEs and preventable ADEs

  7. 双氯芬酸钠的临床应用及不良反应%Clinical application and adverse reaction of diclofenac sodium

    Institute of Scientific and Technical Information of China (English)

    钟云浪; 阮祥梅

    2015-01-01

    目的:探讨双氯芬酸钠的临床应用及不良反应。方法对关于双氯芬酸钠的临床应用评价和不良反应发生情况展开分析探讨。结果双氯芬酸钠具有广泛的临床意义;但可在泌尿系统、皮肤及附件、血液系统、消化系统、神经系统及其他系统出现不良反应,尤其以高年龄段患者发生率较高。结论应重点了解双氯芬酸钠临床应用和其不良反应发生的情况,以便为临床合理用药提供参考,确保患者的用药效果和用药安全。%Objective To investigate the clinical application and adverse reaction of diclofenac sodium. Clinical application and evaluation method of diclofenac sodium and the incidence of adverse reaction was discussed.Methods To evaluate clinical application of diclofenac sodium and the incidence of adverse reaction was discussed. Results Diclofenac sodium has a wide range of clinical sig-niifcance; however, adverse reactions of the urinary tract, skin and its appendages, blood system, digestive system, nervous system and other system appear, especially in older patients with occurrence rate is higher. Conclusion Should be focus on understanding of diclof-enac sodium in clinical application and the occurrence of adverse reactions, in order to provide the reference for clinical rational drug use, to ensure patient outcomes and the medication safety.

  8. Risk factors of adverse drug reaction from non-steroidal anti-inflammatory drugs in Shanghai patients with arthropathy

    Institute of Scientific and Technical Information of China (English)

    Wen SHI; Yong-ming WANG; Shao-li LI; Min YAN; Duan Li; Bin-yah CHEN; Neng-neng CHENG

    2004-01-01

    AIM: The study was to screen the possible risk factors of adverse drug reaction (ADR) induced by non-steroidal anti-inflammatory drugs (NSAIDs) in Shanghai patients with arthropathy. METHODS: The subjects were randomly selected from a database of outpatients with arthropathy from 9 main hospitals in Shanghai. A door to door retrospective epidemiological survey was used to collect demographic information about the patients, both individual and familial. This included data on their medical histories, lifestyle and dietary habits, history of smoking and alcohol consumption, history of drug therapy, quality of life (QOL) prior to NSAIDs intake, history of NSAIDs therapy and its ADR events, etc. Descriptive statistical methods and univariate analysis were also used to identify possible risk factors for ADRs induced by NSAIDs. RESULTS: Of the 1002 patients surveyed, the average length of NSAIDs intake was 2 years. ADR incidence from different NSAIDs was high, in a range from 46.7 %-66.2 %.In general, the candidate risk factors for ADRs were different for each NSAID. Each of the candidate risk factors were defined and studied in order to evaluate its role in the determination of ADRs from NSAIDs. "Family history of ADRs caused by NSAIDs" was found to be a significant risk factor for the four commonly used NSAIDs:meloxicam, diclofenac, nimesulide, and nabumetone. CONCLUSION: A retrospective epidemiological survey was useful in detecting the risk factors for ADRs caused by NSAIDs. The study found that different NSAIDs might have different risk factors and that there is no single risk factor universally applicable to all NSAIDs.

  9. Design of the Anti-tuberculosis Drugs induced Adverse Reactions in China National Tuberculosis Prevention and Control Scheme Study (ADACS

    Directory of Open Access Journals (Sweden)

    He Ping

    2010-05-01

    Full Text Available Abstract Background More than 1 million tuberculosis (TB patients are receiving the standard anti-TB treatment provided by China National Tuberculosis Prevention and Control Scheme (CNTS in China every year. Adverse reactions (ADRs induced by anti-TB drugs could both do harm to patients and lead to anti-TB treatment failure. The ADACS aimed to explore ADRs' incidences, prognoses, economical and public health impacts for TB patients and TB control, and build a DNA bank of TB patients. Methods/Design Multiple study designs were adopted. Firstly, a prospective cohort with 4488 sputum smears positive pulmonary tuberculosis patients was established. Patients were followed up for 6-9 months in 52 counties of four regions. Those suspected ADRs should be checked and confirmed by Chinese State Food and Drug Administration (SFDA. Secondly, if the suspected ADR was anti-TB drug induced liver injury (ATLI, a nested case-control study would be performed which comprised choosing a matched control and doing a plus questionnaire inquiry. Thirdly, health economical data of ADRs would be collected to analyze financial burdens brought by ADRs and cost-effectiveness of ADRs' treatments. Fourthly, a drop of intravenous blood for each patient was taken and saved in FTA card for DNA banking and genotyping. Finally, the demographic, clinical, environmental, administrative and genetic data would be merged for the comprehensive analysis. Discussion ADACS will give an overview of anti-TB drugs induced ADRs' incidences, risk factors, treatments, prognoses, and clinical, economical and public health impacts for TB patients applying CNTS regimen in China, and provide suggestions for individualized health care and TB control policy.

  10. Haplotype-Based Analysis of Genes Associated With Risk of Adverse Skin Reactions After Radiotherapy in Breast Cancer Patients

    International Nuclear Information System (INIS)

    Purpose: To identify haplotypes of single nucleotide polymorphism markers associated with the risk of early adverse skin reactions (EASRs) after radiotherapy in breast cancer patients. Methods and Materials: DNA was sampled from 399 Japanese breast cancer patients who qualified for breast-conserving radiotherapy. Using the National Cancer Institute-Common Toxicity Criteria scoring system, version 2, the patients were grouped according to EASRs, defined as those occurring within 3 months of starting radiotherapy (Grade 1 or less, n = 290; Grade 2 or greater, n = 109). A total of 999 single nucleotide polymorphisms from 137 candidate genes for radiation susceptibility were genotyped, and the haplotype associations between groups were assessed. Results: The global haplotype association analysis (p < 0.05 and false discovery rate < 0.05) indicated that estimated haplotypes in six loci were associated with EASR risk. A comparison of the risk haplotype with the most frequent haplotype in each locus showed haplotype GGTT in CD44 (odds ratio [OR] = 2.17; 95% confidence interval [CI], 1.07-4.43) resulted in a significantly greater EASR risk. Five haplotypes, CG in MAD2L2 (OR = 0.55; 95% CI, 0.35-0.87), GTTG in PTTG1 (OR = 0.48; 95% CI, 0.24-0.96), TCC (OR = 0.48; 95% CI, 0.26-0.89) and CCG (OR = 0.50; 95% CI, 0.27-0.92) in RAD9A, and GCT in LIG3 (OR = 0.46; 95% CI, 0.22-0.93) were associated with a reduced EASR risk. No significant risk haplotype was observed in REV3L. Conclusion: Individual radiosensitivity can be partly determined by these haplotypes in multiple loci. Our findings may lead to a better understanding of the mechanisms underlying the genetic variation in radiation sensitivity and resistance among breast cancer patients

  11. Automatic Identification of Messages Related to Adverse Drug Reactions from Online User Reviews using Feature-based Classification.

    Directory of Open Access Journals (Sweden)

    Jingfang Liu

    2014-11-01

    Full Text Available User-generated medical messages on Internet contain extensive information related to adverse drug reactions (ADRs and are known as valuable resources for post-marketing drug surveillance. The aim of this study was to find an effective method to identify messages related to ADRs automatically from online user reviews.We conducted experiments on online user reviews using different feature set and different classification technique. Firstly, the messages from three communities, allergy community, schizophrenia community and pain management community, were collected, the 3000 messages were annotated. Secondly, the N-gram-based features set and medical domain-specific features set were generated. Thirdly, three classification techniques, SVM, C4.5 and Naïve Bayes, were used to perform classification tasks separately. Finally, we evaluated the performance of different method using different feature set and different classification technique by comparing the metrics including accuracy and F-measure.In terms of accuracy, the accuracy of SVM classifier was higher than 0.8, the accuracy of C4.5 classifier or Naïve Bayes classifier was lower than 0.8; meanwhile, the combination feature sets including n-gram-based feature set and domain-specific feature set consistently outperformed single feature set. In terms of F-measure, the highest F-measure is 0.895 which was achieved by using combination feature sets and a SVM classifier. In all, we can get the best classification performance by using combination feature sets and SVM classifier.By using combination feature sets and SVM classifier, we can get an effective method to identify messages related to ADRs automatically from online user reviews.

  12. Risk of Adverse Cognitive or Behavioral Conditions and Psychiatric Disorders: Evidence Report

    Science.gov (United States)

    Slack, Kelley J.; Williams, Thomas J.; Schneiderman, Jason S.; Whitmire, Alexandra M.; Picano, James J.; Leveton, Lauren B.; Schmidt, Lacey L.; Shea, Camille

    2016-01-01

    In April 2010, President Obama declared a space pioneering goal for the United States in general and NASA in particular. "Fifty years after the creation of NASA, our goal is no longer just a destination to reach. Our goal is the capacity for people to work and learn and operate and live safely beyond the Earth for extended periods of time, ultimately in ways that are more sustainable and even indefinite." Thus NASA's Strategic Objective 1.1 emerged as "expand human presence into the solar system and to the surface of Mars to advance exploration, science, innovation, benefits to humanity, and international collaboration" (NASA 2015b). Any space flight, be it of long or short duration, occurs in an extreme environment that has unique stressors. Even with excellent selection methods, the potential for behavioral problems among space flight crews remain a threat to mission success. Assessment of factors that are related to behavioral health can help minimize the chances of distress and, thus, reduce the likelihood of adverse cognitive or behavioral conditions and psychiatric disorders arising within a crew. Similarly, countermeasures that focus on prevention and treatment can mitigate the cognitive or behavioral conditions that, should they arise, would impact mission success. Given the general consensus that longer duration, isolation, and confined missions have a greater risk for behavioral health ensuring crew behavioral health over the long term is essential. Risk, which within the context of this report is assessed with respect to behavioral health and performance, is addressed to deter development of cognitive and behavioral degradations or psychiatric conditions in space flight and analog populations, and to monitor, detect, and treat early risk factors, predictors and other contributing factors. Based on space flight and analog evidence, the average incidence rate of an adverse behavioral health event occurring during a space mission is relatively low for the

  13. Self-reported physical activity and major adverse events in patients with atrial fibrillation

    DEFF Research Database (Denmark)

    Proietti, Marco; Boriani, Giuseppe; Laroche, Cécile;

    2016-01-01

    ', 'regular', and 'intense', based on patient self-reporting. Data on physical activity were available for 2442 patients: 38.9% reported none, 34.7% occasional, 21.7% regular, and 4.7% intense physical activity. Prevalence of the principal CV risk factors progressively decreased from none to intense physical......AIMS: Physical activity is protective against cardiovascular (CV) events, both in general population and in high-risk CV cohorts. However, the relationship between physical activity with major adverse outcomes in atrial fibrillation (AF) is not well-established. Our aim was to analyse this...... relationship in a 'real-world' AF population. Second, we investigated the influence of physical activity on arrhythmia progression. METHODS AND RESULTS: We studied all patients enrolled in the EURObservational Research Programme on AF (EORP-AF) Pilot Survey. Physical activity was defined as 'none', 'occasional...

  14. Evidence Report: Risk of Crew Adverse Health Event Due to Altered Immune Response

    Science.gov (United States)

    Crucian, Brian; Sams, Clarence F.

    2013-01-01

    The Risk of Crew Adverse Health Event Due to Altered Immune Response is identified by the National Aeronautics and Space Administration (NASA) Human Research Program (HRP) as a recognized risk to human health and performance in space. The HRP Program Requirements Document (PRD) defines these risks. This Evidence Report provides a summary of the evidence that has been used to identify and characterize this risk. It is known that human immune function is altered in- and post-flight, but it is unclear at present if such alterations lead to increased susceptibility to disease. Reactivation of latent viruses has been documented in crewmembers, although this reactivation has not been directly correlated with immune changes or with observed diseases. As described in this report, further research is required to better characterize the relationships between altered immune response and susceptibility to disease during and after spaceflight. This is particularly important for future deep-space exploration missions.

  15. 佐匹克隆的不良反应认识进展%Progress in Understanding of Adverse Reactions of Zopiclone

    Institute of Scientific and Technical Information of China (English)

    孙振晓; 孙宇新; 于相芬

    2016-01-01

    随着佐匹克隆在临床上的广泛应用,对其不良反应的认识不断深入,对佐匹克隆所致不良反应,包括味觉障碍、谵妄、昏迷、严重激越、记忆损害、睡行症、呼吸抑制、急性胰腺炎、急性间质性肾炎、戒断症状、过敏反应、致畸和对哺乳的影响等作一综述.%With the extensive clinical use of zopiclone, the understanding of its adverse reaction is constantly profound. This paper reviews the adverse reactions induced by or associated with zopiclone, such as dysgeusia, delirium, coma, extreme agitation, memory lesion, sleepwalking, respiratory depression, acute pancreatistis, acute interstitial nephritis, withdrawal symptoms, allergic reaction, teratogenicity and breastfeeding.

  16. Variation of adverse drug reaction profile of platinum-based chemotherapy with body mass index in patients with solid tumors: An observational study

    Directory of Open Access Journals (Sweden)

    Dattatreyo Chatterjee

    2014-01-01

    Full Text Available Objectives: Toxicity of cancer chemotherapy may be affected by nutritional status of patients which is reflected in the body mass index (BMI. We sought to assess whether the adverse drug reaction (ADR profile of platinum-based chemotherapy varies with BMI status. Materials and Methods: Adult patients of either sex, suffering from a solid tumor (lung, head and neck, ovary, gall bladder, stomach, colon and started on platinum-based chemotherapy as initial treatment were included. BMI at chemotherapy commencement was obtained from medical records. Events were recorded and graded as per Eastern Co-operative Oncology Group Common Toxicity Criteria-patients′ complaints; clinically evident signs and laboratory reports were considered. Frequencies of individual adverse events were compared between low BMI (<18.5 kg/m 2 and satisfactory BMI groups. Similar comparisons were done for events with grades 2 or 3 severities. Results: A total of 50 patients were observed over a 3-month period of whom 17 (34% belonged to the low BMI group. Nausea, vomiting, diarrhea, stomatitis, anemia, alopecia, tinnitus and paresthesia were the commonly observed ADRs. The frequencies of anemia (P = 0.152 and vomiting (P = 0.140 and severity of grades of nausea (P = 0.066, anemia (P = 0.120 and paresthesia (P = 0.128 showed a higher trend in the low BMI group though differences were not statistically significant. The frequencies of tinnitus (P = 0.021 and paresthesia overall (P = 0.036 were significantly higher in the low BMI group. Conclusion: ADR profile of primary platinum-based chemotherapy appears to be partly influenced by BMI. This suggests the importance of maintaining adequate nutrition in patients and the need for greater vigilance in those with low BMI.

  17. Analysis of spontaneous inquiries about suspected adverse drug reactions posted by the general public on the electronic Japanese bulletin board “Yahoo! Japan Chiebukuro”

    Directory of Open Access Journals (Sweden)

    Dobashi A

    2016-04-01

    Full Text Available Akira Dobashi,1 Kaori Kurata,1 Mitsuhiro Okazaki,2,3 Mari Nishizawa4 1Education and Research Institute of Information Science, Tokyo University of Pharmacy and Life Sciences, Hachioji, Tokyo, 2Faculty of Health Sciences, Health Innovation and Technology Center, Hokkaido University, Hokkaido, 3Cross Care Field Co., Ltd., 4Yakuju Corporation, Tokyo, Japan Purpose: Spontaneous inquiries about the development of adverse drug reactions (ADRs to medicines can be extracted based on the questions posted by the general public on the electronic Japanese bulletin board “Yahoo! Japan Chiebukuro”. Our aim was to clarify the characteristics related to people’s descriptions of suspected ADRs and determine the reasons for submitting a spontaneous inquiry. Methods: Fifty brand names of medicines used for inquiry extraction were chosen by selecting 35 pharmaceutical products, based on the generic names that had the highest sales in Japan. Questions containing both the brand name of one of these medicines and the term “Fukusayō” (ADR in Japanese that were posted from July 2004 to June 2009 were extracted from the site. Results: Among 1,419 questions extracted, 614 questions had at least one identifiable brand name of a suspected medicine, an ADR description, and the extent to which the ADR appeared to be caused by the suspected medicine(s. Among these 614 questions, 589 described in detail the symptoms/signs that the inquirers themselves or their families had experienced as ADRs. The highest number of questions was found for Paxil (525. Posts asking whether the symptoms being experienced were due to an ADR accounted for the highest number of questions. In most cases, the inquirer suspected that a single medicine led to an ADR and was seeking advice from others taking the same medicine. Conclusion: Our examination of spontaneous inquiries showed that people have sufficient knowledge to adequately report potential ADRs in terms of their symptoms

  18. 帕罗西汀的不良反应/事件分析%Analysis on the Adverse Drug Reactions / Events of Paroxetine

    Institute of Scientific and Technical Information of China (English)

    程丽玲; 徐作国

    2012-01-01

    Objective To investigate the adverse drug reactions of Paroxetine, provide a reference for clinical safe use of drugs. Methods Statistically analyzed the articles about adverse reactions of Paroxetine published by mental illness journals for the past 10 years and medical records collected by the author. Results The adverse reactions of Paroxetine involve 9 major categories, with 22 kinds of clinical manifestations, mainly including extrapyramidal reactions(27.91%), blood system injury (11.63%) and allergic reactions(13.95%). Conclusion The adverse drug reactions of Paroxetine are relatively more but gentle, focusing on extrapyramidal injury, hepatic dysfunction, leucopenia and skin allergy.%目的 探讨帕罗西汀的不良反应,为临床安全用药提供参考.方法 对几家精神疾病类杂志近10年有关帕罗西汀不良反应的病例报告和作者临床收集的病例资料进行统计分析.结果 帕罗西汀的不良反应分9大类,22种表现.以锥体外系反应(27.91%)、血液系统损害(11.63%)、过敏反应(13.95%)为多.结论 帕罗西汀的不良反应虽然较多但较和缓,以锥体外系、肝功损害、白细胞减少和皮肤过敏为多.

  19. Neurologic Adverse Events Associated with Voriconazole Therapy: Report of Two Pediatric Cases

    Directory of Open Access Journals (Sweden)

    Sevliya Öcal Demir

    2016-01-01

    Full Text Available Although voriconazole, a triazole antifungal, is a safe drug, treatment with this agent is associated with certain adverse events such as hepatic, neurologic, and visual disturbances. The current report presents two cases, one a 9-year-old boy and the other a 17-year-old girl, who experienced neurologic side effects associated with voriconazole therapy. Our aim is to remind readers of the side effects of voriconazole therapy in order to prevent unnecessary investigations especially for psychological and ophthalmologic problems. The first case was a 9-year-old boy with cystic fibrosis and invasive aspergillosis that developed photophobia, altered color sensation, and fearful visual hallucination. The second case was a 17-year-old girl with cystic fibrosis and allergic bronchopulmonary aspergillosis, and she experienced photophobia, fatigue, impaired concentration, and insomnia, when the dose of voriconazole therapy was increased from 12 mg/kg/day to 16 mg/kg/day. The complaints of the two patients disappeared after discontinuation of voriconazole therapy. Our experience in these patients reminded us of the importance of being aware of the neurologic adverse events associated with voriconazole therapy in establishing early diagnosis and initiating prompt treatment. In addition, although serum voriconazole concentration was not measured in the present cases, therapeutic drug monitoring for voriconazole seems to be critically important in preventing neurologic side effects in pediatric patients.

  20. Neurologic Adverse Events Associated with Voriconazole Therapy: Report of Two Pediatric Cases

    Science.gov (United States)

    Demir, Sevliya Öcal; Atici, Serkan; Akkoç, Gülşen; Yakut, Nurhayat; İkizoğlu, Nilay Baş; Eralp, Ela Erdem; Soysal, Ahmet; Bakir, Mustafa

    2016-01-01

    Although voriconazole, a triazole antifungal, is a safe drug, treatment with this agent is associated with certain adverse events such as hepatic, neurologic, and visual disturbances. The current report presents two cases, one a 9-year-old boy and the other a 17-year-old girl, who experienced neurologic side effects associated with voriconazole therapy. Our aim is to remind readers of the side effects of voriconazole therapy in order to prevent unnecessary investigations especially for psychological and ophthalmologic problems. The first case was a 9-year-old boy with cystic fibrosis and invasive aspergillosis that developed photophobia, altered color sensation, and fearful visual hallucination. The second case was a 17-year-old girl with cystic fibrosis and allergic bronchopulmonary aspergillosis, and she experienced photophobia, fatigue, impaired concentration, and insomnia, when the dose of voriconazole therapy was increased from 12 mg/kg/day to 16 mg/kg/day. The complaints of the two patients disappeared after discontinuation of voriconazole therapy. Our experience in these patients reminded us of the importance of being aware of the neurologic adverse events associated with voriconazole therapy in establishing early diagnosis and initiating prompt treatment. In addition, although serum voriconazole concentration was not measured in the present cases, therapeutic drug monitoring for voriconazole seems to be critically important in preventing neurologic side effects in pediatric patients. PMID:27313918

  1. 'Case reporting of rare adverse events in otolaryngology': can we defend the case report?

    LENUS (Irish Health Repository)

    Dias, Andrew

    2012-01-31

    The study of errors in medicine has proliferated since the publication of The Institute of Medicine Report \\'TO ERR IS HUMAN\\' in 2000. Case nuances and process of care issues are valuable areas to explore if the goal is to provide the health care worker with the knowledge to avoid future errors. Meta-analysis and randomized controlled trials provide a large data base of evidence towards improvement and opportunities, but it is suggested that case reports can still provide valuable clinical information. The aim is to use the published literature to produce a series of rare harm case reports in E.N.T. The methods include systematic literature review. Journals searched in PUBMED were 60. Rare harm case obtained from the search were 5,322. Rare harm case reports not reported in any other form of evidence-based medicine were 40. Yes, the case report can be defended as it is an important pillar of evidence-based medicine.

  2. Adverse events of sacral neuromodulation for fecal incontinence reported to the federal drug administration

    Science.gov (United States)

    Bielefeldt, Klaus

    2016-01-01

    AIM: To investigate the nature and severity of AE related to sacral neurostimulation (SNS). METHODS: Based on Pubmed and Embase searches, we identified published trials and case series of SNS for fecal incontinence (FI) and extracted data on adverse events, requiring an active intervention. Those problems were operationally defined as infection, device removal explant or need for lead and/or generator replacement. In addition, we analyzed the Manufacturer and User Device Experience registry of the Federal Drug Administration for the months of August - October of 2015. Events were included if the report specifically mentioned gastrointestinal (GI), bowel and FI as indication and if the narrative did not focus on bladder symptoms. The classification, reporter, the date of the recorded complaint, time between initial implant and report, the type of AE, steps taken and outcome were extracted from the report. In cases of device removal or replacement, we looked for confirmatory comments by healthcare providers or the manufacturer. RESULTS: Published studies reported adverse events and reoperation rates for 1954 patients, followed for 27 (1-117) mo. Reoperation rates were 18.6% (14.2-23.9) with device explants accounting for 10.0% (7.8-12.7) of secondary surgeries; rates of device replacement or explant or pocket site and electrode revisions increased with longer follow up. During the period examined, the FDA received 1684 reports of AE related to SNS with FI or GI listed as indication. A total of 652 reports met the inclusion criteria, with 52.7% specifically listing FI. Lack or loss of benefit (48.9%), pain or dysesthesia (27.8%) and complication at the generator implantation site (8.7%) were most commonly listed. Complaints led to secondary surgeries in 29.7% of the AE. Reoperations were performed to explant (38.2%) or replace (46.5%) the device or a lead, or revise the generator pocket (14.6%). Conservative management changes mostly involved changes in stimulation

  3. Investigation of the adverse reaction of fluoroquinolones antibiotics%探讨氟喹诺酮类抗生素的不良反应

    Institute of Scientific and Technical Information of China (English)

    黎传宏

    2016-01-01

    目的:探讨氟喹诺酮类抗生素的不良反应。方法:收治应用氟喹诺酮类抗生素治疗患者115例作为研究对象,依据给药方式分为滴注组、口服组。口服组给予口服氟喹诺酮类抗生素,滴注组给予静脉滴注氟喹诺酮类抗生素,比较两组不良反应发生情况。结果:加替沙星引发的不良反应最多,环丙沙星及左氧氟沙星引发的不良反应最少。滴注组不良反应发生率42.11%,明显高于口服组的10.34%,差异有统计学意义(P<0.05)。结论:氟喹诺酮类抗生素的药物类型、给药方式对不良反应发生率均有影响。%Objective:To investigate the adverse reaction of fluoroquinolones antibiotics.Methods:According to the mode of administration,115 cases of patients treated with fluoroquinolone antibiotics were as the research object and were divided into the infusion group and the oral group.Patients in the oral group were given oral fluoroquinolone antibiotics,while patients in the infusion group were given intravenous injection of fluoroquinolone antibiotics.The adverse reactions incidence of two groups were compared.Results:The adverse reactions caused by gatifloxacin was most,and the adverse reactions caused by ciprofloxacin and levofloxacin was least.The adverse reactions incidence of the infusion group was 42.11%,significantly higher than 10.34% of the oral group,and the difference was statistically significant(P<0.05).Conclusion:The drug types and mode of administration of fluoroquinolones antibiotics affected the adverse reaction incidence.

  4. The analysis of the blood donation adverse reaction and its protective countermeasures%献血不良反应的分析及防护对策

    Institute of Scientific and Technical Information of China (English)

    刘林清

    2015-01-01

    Objective: To discuss the causes of blood donation adverse reaction and its protective measures.Methods:The blood pressure vraibles were examined in the voluntary unpaid blood donors for the first time and again as well as the people in different age and different occupations,from the begin of blood sampling to after 30 minutes of its end.TO stop sampling and gave symptomatic treatment due to adverse reactions.Results: The incidence of adverse reactions is 1.13% in 29864 blood donors, among them,the frist and again blood donors are 1.34% and 0.71%;For occupation,The incidence of adverse reactions of the other group is highest,it is 1.89%,instead the medical worker group is lowest,it is 0.50%,there is a statistically significant difference be-tween the two groups and the different age groupP<0.01.Conclusion:The occurrence of adverse reactions is closely related to the history of blood donation,the professional distribution and age;Publicity and preventive care can reduce the incidence of ad-verse reactions effectively.%目的 探讨献血不良反应发生的原因及防护对策.方法 对首次、再次、不同年龄及职业的无偿献血者,自采血开始观察血压、心率、意识等,至采血结束30min,对出现不良反应者中止采血并对症处理.结果 29864名献血者,不良反应发生率1.13%,其中首次、再次献血者分别为1.34%和0.71%;职业分布以其他组最高1.89%,医务人员最低0.50%,二者及不同年龄组间差异均有统计学意义(χ2=20.13,73.51;均P<0.01).结论 献血不良反应的发生与献血史、职业分布、年龄密切相关,宣传、预防护理,可有效降低不良反应发生.

  5. Designing adverse event forms for real-world reporting: participatory research in Uganda.

    Science.gov (United States)

    Davies, Emma C; Chandler, Clare I R; Innocent, Simeon H S; Kalumuna, Charles; Terlouw, Dianne J; Lalloo, David G; Staedke, Sarah G; Haaland, Ane

    2012-01-01

    The wide-scale roll-out of artemisinin combination therapies (ACTs) for the treatment of malaria should be accompanied by continued surveillance of their safety. Post-marketing pharmacovigilance (PV) relies on adverse event (AE) reporting by clinicians, but as a large proportion of treatments are provided by non-clinicians in low-resource settings, the effectiveness of such PV systems is limited. To facilitate reporting, AE forms should be easily completed; however, most are challenging for lower-level health workers and non-clinicians to complete. Through participatory research, we sought to develop user-friendly AE report forms to capture information on events associated with ACTs.Following situation analysis, we undertook workshops with community medicine distributors and health workers in Jinja, Uganda, to develop a reporting form based on experiences and needs of users, and communication and visual perception principles. Participants gave feedback for revisions of subsequent versions. We then conducted 8 pretesting sessions with 77 potential end users to test and refine passive and active versions of the form.The development process resulted in a form that included a pictorial storyboard to communicate the rationale for the information needed and facilitate rapport between the reporter and the respondent, and a diary format to record the drug administration and event details in chronological relation to each other. Successive rounds of pretesting used qualitative and quantitative feedback to refine the form, with the final round showing over 80% of the form completed correctly by potential end users.We developed novel AE report forms that can be used by non-clinicians to capture pharmacovigilance data for anti-malarial drugs. The participatory approach was effective for developing forms that are intuitive for reporters, and motivating for respondents. The forms, or their key components, could be adapted for use in other low-literacy settings to improve quality

  6. Designing adverse event forms for real-world reporting: participatory research in Uganda.

    Directory of Open Access Journals (Sweden)

    Emma C Davies

    Full Text Available The wide-scale roll-out of artemisinin combination therapies (ACTs for the treatment of malaria should be accompanied by continued surveillance of their safety. Post-marketing pharmacovigilance (PV relies on adverse event (AE reporting by clinicians, but as a large proportion of treatments are provided by non-clinicians in low-resource settings, the effectiveness of such PV systems is limited. To facilitate reporting, AE forms should be easily completed; however, most are challenging for lower-level health workers and non-clinicians to complete. Through participatory research, we sought to develop user-friendly AE report forms to capture information on events associated with ACTs.Following situation analysis, we undertook workshops with community medicine distributors and health workers in Jinja, Uganda, to develop a reporting form based on experiences and needs of users, and communication and visual perception principles. Participants gave feedback for revisions of subsequent versions. We then conducted 8 pretesting sessions with 77 potential end users to test and refine passive and active versions of the form.The development process resulted in a form that included a pictorial storyboard to communicate the rationale for the information needed and facilitate rapport between the reporter and the respondent, and a diary format to record the drug administration and event details in chronological relation to each other. Successive rounds of pretesting used qualitative and quantitative feedback to refine the form, with the final round showing over 80% of the form completed correctly by potential end users.We developed novel AE report forms that can be used by non-clinicians to capture pharmacovigilance data for anti-malarial drugs. The participatory approach was effective for developing forms that are intuitive for reporters, and motivating for respondents. The forms, or their key components, could be adapted for use in other low-literacy settings

  7. Low-dose adrenaline, promethazine, and hydrocortisone in the prevention of acute adverse reactions to antivenom following snakebite: a randomised, double-blind, placebo-controlled trial.

    Directory of Open Access Journals (Sweden)

    H Asita de Silva

    2011-05-01

    Full Text Available BACKGROUND: Envenoming from snakebites is most effectively treated by antivenom. However, the antivenom available in South Asian countries commonly causes acute allergic reactions, anaphylactic reactions being particularly serious. We investigated whether adrenaline, promethazine, and hydrocortisone prevent such reactions in secondary referral hospitals in Sri Lanka by conducting a randomised, double-blind placebo-controlled trial. METHODS AND FINDINGS: In total, 1,007 patients were randomized, using a 2 × 2 × 2 factorial design, in a double-blind, placebo-controlled trial of adrenaline (0.25 ml of a 1∶1,000 solution subcutaneously, promethazine (25 mg intravenously, and hydrocortisone (200 mg intravenously, each alone and in all possible combinations. The interventions, or matching placebo, were given immediately before infusion of antivenom. Patients were monitored for mild, moderate, or severe adverse reactions for at least 96 h. The prespecified primary end point was the effect of the interventions on the incidence of severe reactions up to and including 48 h after antivenom administration. In total, 752 (75% patients had acute reactions to antivenom: 9% mild, 48% moderate, and 43% severe; 89% of the reactions occurred within 1 h; and 40% of all patients were given rescue medication (adrenaline, promethazine, and hydrocortisone during the first hour. Compared with placebo, adrenaline significantly reduced severe reactions to antivenom by 43% (95% CI 25-67 at 1 h and by 38% (95% CI 26-49 up to and including 48 h after antivenom administration; hydrocortisone and promethazine did not. Adding hydrocortisone negated the benefit of adrenaline. CONCLUSIONS: Pretreatment with low-dose adrenaline was safe and reduced the risk of acute severe reactions to snake antivenom. This may be of particular importance in countries where adverse reactions to antivenom are common, although the need to improve the quality of available antivenom cannot be

  8. A prospective study on prevalence of adverse drug reactions due to antibiotics usage in otolaryngology department of a tertiary care hospital in North India

    Directory of Open Access Journals (Sweden)

    Farhan Ahmad Khan

    2013-10-01

    Full Text Available Background: Polypharmacy, advancing age and longer duration of hospital stay are the factors responsible for adverse drug reactions (ADRs. This study has attempted to analyze the pattern of antimicrobial prescription in OPD & IPD of the Otolaryngology department and to detect, document, assess and report the suspected ADRs due to antibiotic use and preparation of guidelines to minimize the incidence of ADRs. Methods: A prospective study conducted at the TMMC&RC on patients aged >40 years, who visited the Otolaryngology department over a period of 5 months. Suspected ADRs were assessed for causality and severity using Naranjo’s probability scale and modified Hartwig’s criteria, respectively. Results: Out of 1200, 925 prescriptions were analyzed. Most patients were from 41-60 age (59.45% followed by 61-80 age (37.29% and least from >80 yr (3.24%. But the incidence of ADRs were found to be higher in patients of >80 yr age group n=8 (26.66%. The most commonly prescribed antibacterials were β-Lactams (64.61%. Out of 925 prescriptions studied, only 94 were found to have 154 ADRs. The most commonly identified ADRs were Gastrointestinal 47.40%, followed by Neurotoxicity 24.67%, cutaneous reactions 20.12%, Hepatic 4.54% and Kidney 3.24%. 74.67% of the ADRs were probable and 20.77% were possible type and only 4.54% were definite. 74.67% ADRs were found to be type A, and 25.32% type B. Conclusions: Our study showed that prevalence of ADRs was highest in elder age group and diarrhea was the most common ADR found. Therefore elderly patients should be given special attention when prescribing medications to avoid clinically significant harmful consequences. Minimizing unnecessary antibiotic use by even a small percentage could significantly reduce the immediate and direct risks of drug-related adverse events in individual patients. [Int J Basic Clin Pharmacol 2013; 2(5.000: 548-553

  9. Adverse drug reactions in hospitalised children in Germany are decreasing: results of a nine year cohort-based comparison.

    Directory of Open Access Journals (Sweden)

    Ann-Kathrin Oehme

    Full Text Available BACKGROUND: In recent years, efforts have been made to improve paediatric drug therapy. The aim of this research was to investigate any changes regarding the frequency and nature of adverse drug reactions (ADRs in hospitalized children in one paediatric general medical ward over a 9-year period. METHODOLOGY: Two prospective observational cohort studies were conducted at a large University hospital in Germany in 1999 and 2008, respectively. Children aged 0-18 years admitted to the study ward during the study periods were included. ADRs were identified using intensive chart review. Uni- and multivariable regression has been used for data analysis. RESULTS: A total of 520 patients (574 admissions were included [1999: n = 144 (167; 2008: n = 376 (407]. Patients received a total of 2053 drugs [median 3, interquartile range (IQR 2-5]. 19% of patients did not receive any medication. Median length of stay was 4 days (IQR 3-7; range 1-190 days with a significantly longer length of stay in 1999. The overall ADR incidence was 13.1% (95% CI, 9.8-16.3 varying significantly between the two study cohorts [1999: 21.9%, 95% CI, 14.7-29.0; 2008: 9.2%, 95% CI, 5.9-12.5 (p<0.001]. Antibacterials and corticosteroids for systemic use caused most of the ADRs in both cohorts (1999; 2008. Exposure to systemic antibacterials decreased from 62.9% to 43.5% whereas exposure to analgesics and anti-inflammatory drugs increased from 17.4% to 45.2%, respectively. The use of high risk drugs decreased from 75% to 62.2%. In 1999, 45.7% and in 2008 96.2% of ADRs were identified by treating clinicians (p<0.001. CONCLUSIONS: Between 1999 and 2008, the incidence of ADRs decreased significantly. Improved treatment strategies and an increased awareness of ADRs by physicians are most likely to be the cause for this positive development. Nevertheless further research on ADRs particularly in primary care and the establishment of prospective pharmacovigilance systems are still

  10. Adverse Drug Reactions Causing Admission to Medical Wards: A Cross-Sectional Survey at 4 Hospitals in South Africa.

    Science.gov (United States)

    Mouton, Johannes P; Njuguna, Christine; Kramer, Nicole; Stewart, Annemie; Mehta, Ushma; Blockman, Marc; Fortuin-De Smidt, Melony; De Waal, Reneé; Parrish, Andy G; Wilson, Douglas P K; Igumbor, Ehimario U; Aynalem, Getahun; Dheda, Mukesh; Maartens, Gary; Cohen, Karen

    2016-05-01

    Limited data exist on the burden of serious adverse drug reactions (ADRs) in sub-Saharan Africa, which has high HIV and tuberculosis prevalence. We determined the proportion of adult admissions attributable to ADRs at 4 hospitals in South Africa. We characterized drugs implicated in, risk factors for, and the preventability of ADR-related admissions.We prospectively followed patients admitted to 4 hospitals' medical wards over sequential 30-day periods in 2013 and identified suspected ADRs with the aid of a trigger tool. A multidisciplinary team performed causality, preventability, and severity assessment using published criteria. We categorized an admission as ADR-related if the ADR was the primary reason for admission.There were 1951 admissions involving 1904 patients: median age was 50 years (interquartile range 34-65), 1057 of 1904 (56%) were female, 559 of 1904 (29%) were HIV-infected, and 183 of 1904 (10%) were on antituberculosis therapy (ATT). There were 164 of 1951 (8.4%) ADR-related admissions. After adjustment for age and ATT, ADR-related admission was independently associated (P ≤ 0.02) with female sex (adjusted odds ratio [aOR] 1.51, 95% confidence interval [95% CI] 1.06-2.14), increasing drug count (aOR 1.14 per additional drug, 95% CI 1.09-1.20), increasing comorbidity score (aOR 1.23 per additional point, 95% CI 1.07-1.41), and use of antiretroviral therapy (ART) if HIV-infected (aOR 1.92 compared with HIV-negative/unknown, 95% CI 1.17-3.14). The most common ADRs were renal impairment, hypoglycemia, liver injury, and hemorrhage. Tenofovir disoproxil fumarate, insulin, rifampicin, and warfarin were most commonly implicated, respectively, in these 4 ADRs. ART, ATT, and/or co-trimoxazole were implicated in 56 of 164 (34%) ADR-related admissions. Seventy-three of 164 (45%) ADRs were assessed as preventable.In our survey, approximately 1 in 12 admissions was because of an ADR. The range of ADRs and implicated drugs reflect South Africa's high HIV

  11. 莫西沙星的严重不良反应及其防范%Severe Adverse Drug Reactions Induced by Moxifloxacin and Their Prevention

    Institute of Scientific and Technical Information of China (English)

    陈晨钟; 史道华

    2011-01-01

    目的:提示临床高度关注莫西沙星的不良反应.方法:检索我院不良反应监测系统,对其中莫西沙星产生的3例严重不良反应报告进行分析.结果:3例莫西沙星严重不良反应中,暴发性肝衰竭1例,经抢救无效死亡;过敏性休克2例,经抢救未产生严重后果.结论:临床应重视莫西沙星严重不良反应的危害性.%OBJECTIVE: To prompt the adverse drug reactions (ADR) of moxifloxacin should be paid high attention to clinic.METHODS: Retrieved from ADR reporting and monitoring system of our hospital, 3 serious ADR cases induced by moxifloxacin were analyzed. RESULTS: Among 3 serious ADR cases induced by moxifloxacin, one case developed fulminant hepatic failure leading to death after rescue, and other 2 patients with anaphylactic shock was recovered without severe consequence after rescue.CONCLUSION:Great importance should be attached to ADR induced by moxifloxacin in the clinic.

  12. Analysis on 70 Cases of Serious Adverse Drug Reactions%70例严重药品不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    张利国; 周颖; 张琼丹; 曾永兰

    2013-01-01

    Objective To understand the situation of serious adverse drug reactions ( ADR ) occurred in hospital for promoting the clinical medication safety. Methods The case reports of serious ADR during 2009-2011 were performed the retrospective analysis. Results ADR involving drugs were 6 categories 38 varieties,dominated by anticancer drugs,followed by antimicrobial drugs. The administration route was mainly intravenous infusion, accounting for 80% . The manifestations of ADR were dominated by leukopenia. Conclusion The awareness of rational drug use should be enhanced to avoid severe ADR and reduce the medical disputes.%目的 了解医院严重药品不良反应(ADR)发生情况,促进临床用药安全.方法 对2009年至2011年70例严重药品不良反应报告进行回顾性分析.结果 不良反应涉及药品6大类38种,以抗肿瘤药物为主,其次是抗微生物药物;给药途径以静脉滴注为主,占80%;不良反应表现主要以白细胞减少为主.结论 增强合理用药意识,避免严重ADR发生,减少医疗纠纷.

  13. Association analysis of CYP2C9*3 and phenytoin-induced severe cutaneous adverse reactions (SCARs) in Thai epilepsy children.

    Science.gov (United States)

    Suvichapanich, Supharat; Jittikoon, Jiraphun; Wichukchinda, Nuanjun; Kamchaisatian, Wasu; Visudtibhan, Anannit; Benjapopitak, Suwat; Nakornchai, Somjai; Manuyakorn, Wiparat; Mahasirimongkol, Surakameth

    2015-08-01

    CYP2C9 is the key enzyme in aromatic antiepileptic drugs (AEDs) metabolism. CYP2C9*3 is a loss of function polymorphism. This study was designed to investigate genetic association between CYP2C9*3 and aromatic AED-induced severe cutaneous adverse reactions (SCARs) in Thai children. The 37 aromatic AED-induced SCARs patients (20 phenobarbital and 17 phenytoin) and 35 tolerances (19 phenobarbital and 16 phenytoin) were enrolled. CYP2C9*3 was genotyped by allele-specific PCRs. The association between CYP2C9*3 with phenytoin-induced SCARs and phenobarbital-induced SCARs were analyzed in comparison with tolerances and healthy samples. Significant association between phenytoin-induced SCARs and CYP2C9*3 was discovered (odds ratio=14.52; 95% confidence interval (CI)=1.18-∞, P-value=0.044). CYP2C9*3 was not associated with phenobarbital-induced SCARs. This study is the first report of CYP2C9*3 association to phenytoin-induced SCARs in Thai epileptic children. The CYP2C9*3 is a reasonable predictive genetic marker to anticipate SCARs from phenytoin. PMID:25994870

  14. To what extent are adverse events found in patient records reported by patients and healthcare professionals via complaints, claims and incident reports?

    Directory of Open Access Journals (Sweden)

    van der Wal Gerrit

    2011-02-01

    Full Text Available Abstract Background Patient record review is believed to be the most useful method for estimating the rate of adverse events among hospitalised patients. However, the method has some practical and financial disadvantages. Some of these disadvantages might be overcome by using existing reporting systems in which patient safety issues are already reported, such as incidents reported by healthcare professionals and complaints and medico-legal claims filled by patients or their relatives. The aim of the study is to examine to what extent the hospital reporting systems cover the adverse events identified by patient record review. Methods We conducted a retrospective study using a database from a record review study of 5375 patient records in 14 hospitals in the Netherlands. Trained nurses and physicians using a method based on the protocol of The Harvard Medical Practice Study previously reviewed the records. Four reporting systems were linked with the database of reviewed records: 1 informal and 2 formal complaints by patients/relatives, 3 medico-legal claims by patients/relatives and 4 incident reports by healthcare professionals. For each adverse event identified in patient records the equivalent was sought in these reporting systems by comparing dates and descriptions of the events. The study focussed on the number of adverse event matches, overlap of adverse events detected by different sources, preventability and severity of consequences of reported and non-reported events and sensitivity and specificity of reports. Results In the sample of 5375 patient records, 498 adverse events were identified. Only 18 of the 498 (3.6% adverse events identified by record review were found in one or more of the four reporting systems. There was some overlap: one adverse event had an equivalent in both a complaint and incident report and in three cases a patient/relative used two or three systems to complain about an adverse event. Healthcare professionals

  15. 注射用盐酸多西环素致静脉炎3例及不良反应文献复习%Literature Review of Doxycycline Hyclate for Injection Induced Phlebitis in 3 Adverse Reactions Cases

    Institute of Scientific and Technical Information of China (English)

    吴蔚; 蓝茜榆

    2016-01-01

    Objective To enhance the knowledge of the adverse reaction induced by doxycycline hydrochloride,and to protect the safety of patients. Methods To report and analyze 3 cases of phlebitis caused by doxycycline hydrochloride for injection,relevant literatures in China National Knowledge Infrastructure,Wanfang Database,VIP network and PubMed were retrieved and collected to summary and analyze its adverse reactions. Results Doxycycline hydrochloride for injection can cause phlebitis. There were 8 cases of serious adverse reactions life-threatening in the literatures of adverse reactions caused by doxycycline hydrochloride,4 cases were induced by intra-venous administration,which accounted for 8