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Drug Reactions (drug + reaction)
Kinds of Drug Reactions Selected AbstractsNew guideline for tramadol usage following adverse drug reactions reported to the Iranian pharmacovigilance center,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 2 2007K. Gholami Pharm D Abstract Background Tramadol was introduced as injection and oral form to Iranian Pharmaceutical Market in 2002. Shortly after, the injection form of the drug was observed at the top of suspected drug list of Adverse Drug Reactions (ADRs) received monthly by Iranian Pharmacovigilance Center (IPC). Objectives To detect, assess and report total number of Tramadol-induced ADRs received by IPC. To assess the frequency of reported Tramadol-induced ADRs before and after interventions. To design a guideline for prevention of probable ADRs due to Tramadol injection. Methods A descriptive study was conducted on spontaneous reporting received by IPC from April 2002 to February 2005. All ADRs suspected to be induced by Tramadol registered in the database during mentioned period were analysed. To assess the effect of different interventions based on Spontaneous Reporting System, the trend of reporting frequency of Tramadol-induced ADRs was evaluated before and after interventions. Results There were 337 cases of Tramadol-induced ADRs describing 939 reactions, reported to IPC during the study period. Although causal relationship had not been established, three cases of deaths appeared among the reports. The severity of reactions led to implementation of limitations on injectable Tramadol distribution to community pharmacies and the restriction of its use to hospitals only. Since most adverse reactions were dose-dependent, the drug potency of injectable Tramadol available in the country changed from 100,mg to 50,mg. The assessment of ADR reports received by IPC showed that the frequency of adverse reactions registered in the centre was reduced considerably following these interventions. Conclusion Designing a detailed programme by Pharmacovigilance Centres and closely monitoring of newly marketed pharmaceutical products is highly recommended. Copyright © 2006 John Wiley & Sons, Ltd. [source] Relationship between Serum Acetaminophen Concentration and N -Acetylcysteine-Induced Adverse Drug ReactionsBASIC AND CLINICAL PHARMACOLOGY & TOXICOLOGY, Issue 3 2010Sa'ed H. Zyoud 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 < 0.001), rash (p < 0.001) and pruritus (p < 0.001). However, there were no significant differences in serum 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. [source] Experience in adverse events detection in an emergency department: Nature of eventsEMERGENCY MEDICINE AUSTRALASIA, Issue 1 2007James Hendrie Abstract Objective:, The study was performed to determine the nature of adverse events in an ED. Methods:, The methodology has been described in the accompanying paper. Two by two tables were analysed using the two-tailed Fisher's exact test. A P -value of ,0.05 was considered significant. Statistical analysis was performed using MINITAB. Results:, One hundred and ninety-four events were detected, from a sample of 3222 patients. Except where specified, events with management causation ,3 were excluded. This excluded 24 events (12.4%) leaving 170 for analysis. Errors of commission occurred in 55% and omission in 45%. Errors of commission were significantly associated with prior events, errors of omission with ED events (P , 0.0001, respectively). The most common cause of events was drug reactions. 1.35% had a Naranjo score , 1, 0.54% , 4. Prior events were significantly associated with adverse drug reactions (P , 0.0001). Drug reactions were associated with a lower preventability score (P , 0.0001). Diagnostic issues were present in 1.2%. All three categories, that is diagnosis not considered, diagnosis within the differential and seriousness not appreciated were associated preventability ,4 (P , 0.0001, P , 0.02 and P , 0.004, respectively). Diagnostic problems were significantly associated with ED events (P , 0.0001). Conclusion:, In conclusion, the data demonstrate that events fall into two sets: prior events which are associated with errors of commission, drug reactions and lower preventability; and ED events which are associated with errors of omission, diagnostic issues and high preventability. [source] Antipsychotic-induced weight gainDIABETES OBESITY & METABOLISM, Issue 5 2005A. J. Goudie Abstract:, Novel ,atypical' antipsychotic drugs represent a substantial improvement on older ,typical' drugs. However, clinical experience has shown that some, but not all, of these drugs can induce substantial weight gain. This interferes with compliance with drug taking and has expected effects on morbidity and mortality. In this review, we summarize current thinking on: (i) the extent to which different ,atypical' drugs induce weight gain; (ii) the possible roles of various neurotransmitters and neuropeptides in this adverse drug reaction; and (iii) the state of development of animal models in this area. We also outline major areas for future research. [source] Carbamazepine-induced drug-induced hypersensitivity syndrome in a 14-year-old Japanese boyEPILEPSIA, Issue 12 2008Yuka Suzuki Summary Drug-induced hypersensitivity syndrome (DIHS) is a life-threatening idiosyncratic drug reaction, and an early accurate diagnosis is essential for its treatment. We describe a 14-year-old boy with localization-related epilepsy, who developed severe adverse cutaneous and systemic reactions after 3 weeks of carbamazepine administration. During the course of the clinical symptoms, reactivation of human herpesvirus 6 (HHV-6) was proven by detection of the HHV-6 genome in serum and elevation of HHV-6 immunoglobulin G (IgG). He fulfilled the newly established criteria for DIHS. Among eight identified medications that can precipitate DIHS, four are antiepileptic drugs. Establishing a treatment strategy for DIHS is warranted to improve its outcome. Therefore, it is important to raise awareness of DIHS among epileptologists. [source] Efficacy of four insect repellents against mosquito bites: a double-blind randomized placebo-controlled field study in SenegalFUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 5 2009Bernard Uzzan Abstract Insect-borne diseases represent a worldwide threat. In addition to fight against vectors (insecticides) and disease prevention (vaccination against yellow fever, chemoprophylaxis against malaria), insect repellents applied on the skin could help reduce the heavy burden related to these diseases. In a field study performed in Senegal, we compared the efficacy of one skin application between 3 and 4 p.m. of four spray repellents [icaridine 20%, para-menthane-diol (PMD) 20% and 50% and DEET 50%] against placebo, among 100 healthy male and female volunteers experienced with mosquito capture. Double-blind randomized cross-over placebo-controlled study (Latin-square design) during five consecutive nights (7 p.m. to midnight) in two villages was conducted. To avoid residual effect, right or left leg was alternately exposed during consecutive nights and the exposed leg was washed before next night. The statistical model was random and mixed effects anova. All four active repellents provided a significant and similar protection compared with placebo, lasting 8 h. However, there was a non-significant trend for a higher protection by DEET 50% than by PMD 20% (P = 0.07). Duration of protection was similar for all repellents. Their effects were similar among men and women, and against Anopheles or other species. No serious adverse drug reaction was noticed. Using a rigorous methodology and a large number of volunteers, our well-controlled study demonstrated an important and similar protective effect of all four repellents compared with placebo. Such field studies should be required before approval of any newly developed repellent. [source] The application of knowledge discovery in databases to post-marketing drug safety: example of the WHO databaseFUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 2 2008A. Bate Abstract After market launch, new information on adverse effects of medicinal products is almost exclusively first highlighted by spontaneous reporting. As data sets of spontaneous reports have become larger, and computational capability has increased, quantitative methods have been increasingly applied to such data sets. The screening of such data sets is an application of knowledge discovery in databases (KDD). Effective KDD is an iterative and interactive process made up of the following steps: developing an understanding of an application domain, creating a target data set, data cleaning and pre-processing, data reduction and projection, choosing the data mining task, choosing the data mining algorithm, data mining, interpretation of results and consolidating and using acquired knowledge. The process of KDD as it applies to the analysis of spontaneous reports can be exemplified by its routine use on the 3.5 million suspected adverse drug reaction (ADR) reports in the WHO ADR database. Examples of new adverse effects first highlighted by the KDD process on WHO data include topiramate glaucoma, infliximab vasculitis and the association of selective serotonin reuptake inhibitors (SSRIs) and neonatal convulsions. The KDD process has already improved our ability to highlight previously unsuspected ADRs for clinical review in spontaneous reporting, and we anticipate that such techniques will be increasingly used in the successful screening of other healthcare data sets such as patient records in the future. [source] A case of acute hepatitis E associated with multidrug hypersensitivity and cytomegalovirus reactivationHEPATOLOGY RESEARCH, Issue 2 2007Yasuhiro Takikawa A 65-year-old Japanese man was hospitalized because of acute hepatitis and severe cholestasis due to hepatitis E virus (HEV) infection combined with a drug reaction to a cold preparation. He died of disseminated intravascular coagulation and severe intestinal bleeding due to systemic cytomegalovirus reactivation following the development of severe eruptions with marked eosinophilia due to drug hypersensitivity to taurine and ursodeoxycholate preparations. The close interaction between viral infection or reactivation and drug hypersensitivity was considered as a pathophysiology in this case, which emphasizes the need for further study of the immunological mechanism of the interaction. [source] Celecoxib-induced photoallergic drug eruptionINTERNATIONAL JOURNAL OF DERMATOLOGY, Issue 6 2004Ayca Cordan Yazici MD Photoallergic dermatitis is caused by a photosensitizing substance plus sunlight exposure in a sensitized person. If the photosensitizer is delivered internally, it is called a photoallergic drug reaction. Celecoxib is a new generation non-steroidal anti-inflammatory drug and sulfonamide derivative. We report a photoallergic drug eruption associated with the introduction of celecoxib. To our knowledge, this is the first report of photoallergic drug reaction associated with celecoxib. [source] Severe drug-induced skin reactions: clinical pattern, diagnostics and therapyJOURNAL DER DEUTSCHEN DERMATOLOGISCHEN GESELLSCHAFT, Issue 2 2009Maja Mockenhaupt Summary The spectrum of severe drug-induced skin reactions includes not only Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) but also generalized bullous fixed drug eruption (GBFDE), acute generalized exanthematous pustulosis (AGEP) and hypersensitivity syndrome (HSS), also called drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions differ in clinical presentation as well as prognosis, causative agents and therapy. Therefore, the appropriate diagnostic measures should be undertaken rapidly, in order to prove the diagnosis. In addition to a thorough clinical examination, a skin biopsy should be taken and specific laboratory investigations should be done if AGEP or HSS/DRESS is suspected. Since these reactions are drug-induced, the causative agent should be rapidly identified and withdrawn. Besides adequate supportive therapy, systemic immunomodulatory treatments may be considered. Despite intensive care management, the prognosis in SJS and TEN is often poor and influenced by the amount of skin detachment as well as the age of the patients and the pre-existing underlying conditions. Severe sequelae may develop in survivors and affect especially mucosal sites. The prognosis of GBFDE is better but recurrent events may lead to more severe involvement. In HSS/DRESS sequelae have been also described as well as long lasting and recurrent courses, whereas AGEP usually heals without problems. [source] Neutropenia, thrombocytopenia and hepatic injury associated with dexketoprofen trometamol therapy in a previously healthy 35-year-old womanJOURNAL OF CLINICAL PHARMACY & THERAPEUTICS, Issue 1 2008S. Zabala MD Summary This case report describes a previously healthy 35-year-old woman, with an episode of fever, neutropenia, thrombocytopenia and elevation of biochemical markers of liver injury, 10 days after beginning drug therapy with dexketoprofen trometamol. Infectious and autoimmune causes of neutropenia, and viral or autoimmune hepatitis were excluded. The resolution following withdrawal of dexketoprofen trometamol confirms the possibility of an adverse drug reaction. [source] Toxic epidermal necrolysis; 15 years' experience in a Dutch burns centreJOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 6 2007B Gerdts Abstract Background, Toxic epidermal necrolysis (TEN) is a severe and potentially fatal drug reaction characterized by an extensive skin rash with blisters and exfoliation, frequently accompanied by mucositis. The wounds caused by TEN are similar to second-degree burns and severe cases may involve large areas of skin loss. Objectives, Analysis of our results in patients with TEN and evaluation of the variety of therapeutic interventions that has been studied and suggested in TEN. Patients/methods, Retrospective analysis of 19 consecutive patients with TEN treated in our burns centre between 1989 and 2004. Results, Immediate withdrawal of any potentially fatal drug, maximum supportive care, and a restricted and tailored antibiotic, medical and surgical treatment regimen confined mortality to 21%, whereas prognosis scores like APACHE II and SCORTEN predicted mortality of 22 and 30%, respectively. A positive contribution of selective digestive decontamination is suggested but has yet to be established. Conclusions, Because of a potentially fatal outcome, fast referral of a patient suspected of TEN to a specialized centre (mostly a burns unit or specialized dermatology centre) for expert wound management and tailored comprehensive care is strongly advised and contributes to survival. [source] Drug-specific in vitro release of IL-2, IL-5, IL-13 and IFN-, in patients with delayed-type drug hypersensitivityALLERGY, Issue 9 2009P. Lochmatter Background:, The most prevalent drug hypersensitivity reactions are T-cell mediated. The only established in vitro test for detecting T-cell sensitization to drugs is the lymphocyte transformation test, which is of limited practicability. To find an alternative in vitro method to detect drug-sensitized T cells, we screened the in vitro secretion of 17 cytokines/chemokines by peripheral blood mononuclear cells (PBMC) of patients with well-documented drug allergies, in order to identify the most promising cytokines/chemokines for detection of T-cell sensitization to drugs. Methods:, Peripheral blood mononuclear cell of 10 patients, five allergic to ,-lactams and five to sulfanilamides, and of five healthy controls were incubated for 3 days with the drug antigen. Cytokine concentrations were measured in the supernatants using commercially available 17-plex bead-based immunoassay kits. Results:, Among the 17 cytokines/chemokines analysed, interleukin-2 (IL-2), IL-5, IL-13 and interferon-, (IFN-,) secretion in response to the drugs were significantly increased in patients when compared with healthy controls. No difference in cytokine secretion patterns between sulfonamide- and ,-lactam-reactive PBMC could be observed. The secretion of other cytokines/chemokines showed a high variability among patients. Conclusion:, The measurement of IL-2, IL-5, IL-13 or IFN-, or a combination thereof might be a useful in vitro tool for detection of T-cell sensitization to drugs. Secretion of these cytokines seems independent of the type of drug antigen and the phenotype of the drug reaction. A study including a higher number of patients and controls will be needed to determine the exact sensitivity and specificity of this test. [source] Cutaneous adverse drug reaction induced by a generic substitute of Zyloric® with a residual sensitization to allopurinolALLERGY, Issue 12 2006M.-L. Chandeclerc No abstract is available for this article. [source] Questionnaire-based survey of lifetime-prevalence and character of allergic drug reactions in German childrenPEDIATRIC ALLERGY AND IMMUNOLOGY, Issue 7 2008L. Lange Data on the epidemiology of adverse drug reactions (ADR), especially allergic drug reactions, in children are rare. The reported prevalence of ADR in pediatric populations varies a lot, depending on type of the study and the country where the data were collected. In order to assess the prevalence of ADR and allergic drug reactions in a population of German children, we conducted a study in a German pediatric university hospital. A questionnaire concerning occurrence and character of ADR was distributed to all parents presenting their children in the hospital for planned admissions or in the emergency department from May 2004 to November 2004. Additional telephone interviews were conducted to specify the reported symptoms in ambiguous cases. One thousand four hundred forty-seven questionnaires were collected. The reported life-time prevalence of ADR according to the information given by the parents was 7.5% (108/1447). Six of the reactions were severe, three children had experienced anaphylactic reactions. In 4.2% (61/1447), the history was suspicious for a potential allergic mechanism because of an immediate or late phase cutaneous drug reaction. In this group, the suspected drugs were antibiotics in 85% (32.7% aminopenicillins, 29.5% other penicillins, 11.5% cefaclor, 8.2% macrolides and 18% others), antiphlogistic and respiratory drugs in 4.9% each and vaccines and contrast media in 3.3% each. There was a higher percentage of children under the age of four suffering from ADR. This trend was not significant when analyzing only the allergic reactions. Forty-four percent of the parents stated, their children suffer from drug allergy, although a clear non-allergic reaction was described. Both, ADR and allergic drug reactions are frequent phenomena in children. It is important to monitor drug therapy for any adverse reaction in order to inform the parents about the character of the adverse reaction, the necessary consequences and to initiate further diagnostic procedures. [source] Allopurinol-Induced DRESS Syndrome in an Adolescent PatientPEDIATRIC DERMATOLOGY, Issue 3 2010Ashvin K. Dewan B.S. Initial laboratory evaluation revealed leukocytosis, eosinophilia, and transaminitis. After extensive work-up and exclusion of infectious and oncologic etiologies, the diagnosis of allopurinol-induced drug reaction and eosinophilia with systemic symptoms syndrome was carried out. The patient responded to administration of IV methylprednisolone, with complete resolution of symptoms and improvement of laboratory abnormalities. This case represents the first report of allopurinol-induced drug reaction and eosinophilia with systemic symptoms syndrome in a pediatric patient. [source] Neuroleptic malignant syndrome and its controversies,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 5 2010Branimir Margeti Abstract Purpose Neuroleptic malignant syndrome (NMS) is a rare and life threatening condition usually defined as a complication of treatment with antipsychotics characterized by severe rigidity, tremor, fever, altered mental status, autonomic dysfunction, and elevated serum creatine phosphokinase and white blood cell count. The literature on this topic is rather extensive, but many aspects related to the syndrome are thought to be controversial. The aim of this paper, written with the clinician in mind, is to summarize some of the most prominent controversies that may have importance in usual clinical practice. Methods The literature was searched for reviews, reports on the series of cases, individual case reports of NMS, and other clinically and theoretically important information. Results There are controversies associated with virtually all important aspects of NMS. At the moment, it is not clear if this drug reaction is idiosyncratic or not, what diagnostic criteria are the most appropriate for usual clinical practice, and it seems that the estimated incidence is not in accordance with the number of treated patients. There are rather different approaches to the pathophysiological mechanisms, differential diagnosis, and treatment. Conclusions Some of the controversies related to NMS have an influence on our understanding of the condition and may have importance in clinical practice. There is a need for further research that should elucidate these controversies. Copyright © 2010 John Wiley & Sons, Ltd. [source] Influence of genetic variation in CYP3A4 and ABCB1 on dose decrease or switching during simvastatin and atorvastatin therapy,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 1 2010Matthijs L. Becker PharmD Abstract Purpose Simvastatin and atorvastatin are metabolized by the CYP3A4 enzyme and transported by the ABCB1 transporter. We studied whether the polymorphism CYP3A4*1B and the polymorphisms C1236T, G2677A/T and C3435T in the ABCB1 gene were associated with a decrease of the prescribed dose or a switch to another cholesterol lowering drug during simvastatin and atorvastatin therapy. These events may indicate that statin plasma levels were too high and resulted in an adverse drug reaction or a too strong reduction in cholesterol level. Methods We identified 1239 incident simvastatin and atorvastatin users in the Rotterdam Study, a population-based cohort study. Associations between the polymorphisms in the CYP3A4 and ABCB1 gene and the time to a decrease in dose or a switch to another cholesterol lowering drug were studied using Cox proportional hazards. Results Simvastatin and atorvastatin users with the CYP3A4*1B variant G allele had a lower risk (HR 0.46; 95%CI 0.24,0.90) for these events than users with the wild-type AA genotype. No significant associations were found for the ABCB1 polymorphisms. The association with the CYP3A4*1B polymorphism was found in women (HR 0.33; 95%CI 0.12,0.89) and was non-significant in men (HR 0.69 95%CI 0.28,1.70). This association was stronger in patients with the ABCB1 3435T variant allele versus the G allele. Conclusion In simvastatin and atorvastatin users, the CYP3A4*1B G allele is associated with a lower risk of elevated statin plasma levels, particularly in women and in users with the ABCB1 3435T variant allele. Copyright © 2009 John Wiley & Sons, Ltd. [source] Adverse drug reaction-related hospitalisations: a population-based cohort studyPHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 4 2008Cornelis S. van der Hooft MD Abstract Purpose To evaluate the extent, characteristics and determinants of adverse drug reaction (ADR)-related hospitalisations on a population-based level in 2003. Methods We performed a cohort study in the Integrated Primary Care Information (IPCI) database, a general practitioners (GPs) research database with longitudinal data from electronic patient records of a group of 150 GP throughout the Netherlands. Hospital discharge letters and patient records were reviewed to evaluate ADR-related hospitalisations applying WHO causality criteria. The prevalence of ADR-related hospitalisations per total admissions and the incidence per drug group were calculated. Avoidability and seriousness of the ADRs causing admission were assessed applying the algorithm from Hallas. Results We identified 3515 hospital admissions, 1277 elective and 2238 acute. Of the acute admissions, 115 were caused by an ADR giving a prevalence of 5.1% (95% confidence intervals (CI): 4.3,6.1%). The prevalence of ADR-related acute admissions increased with age up to 9.8% (95%CI: 7.5,12.7) for persons >75 years. The ADRs that most frequently caused hospitalisations were gastro-intestinal bleeding with anti-thrombotics, bradycardia/hypotension with cardiovascular drugs and neutropenic fever with cytostatics. The incidence rate of ADR-related hospitalisations per drug group was highest for anti-thrombotics and anti-infectives and was relatively low for cardiovascular drugs. Fatality as a direct consequence of the ADR-related admission was 0.31%. In elderly patients 40% of the ADRs causing hospitalisation were judged to be avoidable. Conclusions The extent and potential avoidability of ADR-related hospitalisations is still substantial, especially in elderly patients. Measures need to be put into place to reduce the burden of ADRs. Copyright © 2008 John Wiley & Sons, Ltd. [source] Reporting of adverse drug reactions: predictors of under-reporting in Malaysia,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 2 2007Zoriah Aziz PhD Abstract Background Malaysia like many other countries worldwide uses spontaneous reporting systems as a mean of collecting data on suspected adverse drug reaction (ADR). However, compared to other countries, which use the system, the reporting rate in Malaysia is very low. Why some physicians do not report ADRs is not well understood. Objective To identify factors, which would predict physicians' failure to send ADR reports. Design and Setting Face-to-face interview using a structured questionnaire involving physicians working at the University of Malaya Medical Centre, Malaysia. Results About a third of the physicians in the Centre participated. Sixty-five of the 415 approached refused to participate. A high proportion of the respondents (81.4%) indicated that they had suspected an ADR but did not report it, while about 40% of the respondents were not aware of the existence of the national reporting system in Malaysia. Logistic regression modelling identified the variable ,ADR considered to be too trivial or too well known to report' as the strongest predictor of not reporting, followed by physicians' category and uncertainty that the reaction had been definitely caused by a drug. Conclusion Important predictor variables, which limit physicians from reporting ADR in Malaysia, were related to uncertainty of types of reaction to report, lack of awareness about the existence, function and purpose of national ADR reporting. The findings could be useful for planning strategies to improve the reporting rate. Copyright © 2006 John Wiley & Sons, Ltd. [source] Utilization of hospital and outpatient care for adverse cutaneous reactions to medicationsPHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 10 2005Robert S. Stern MD Abstract Purpose To quantify hospitalizations, visits to office based physicians, hospital clinics and emergency departments with primary diagnoses of skin conditions that are often due to drug reaction. Methods I analyzed data from the National Hospital Discharge Summary (1997,2001), National Ambulatory Care Survey (1995,2000) and National Hospital Ambulatory Care Survey (1995,2000) to determine the number of hospitalizations and visits with primary diagnoses of skin conditions that are often attributed to drugs. Using statistical methods for surveys, I determined the demographic characteristics of patients with these diagnoses and compared them with patients seeking care for other reasons. Results In the United States, there are about 5000 hospitalizations each year with a primary diagnosis of erythema multiform, Stevens,Johnson Syndrome or Toxic Epidermal Necrolysis, of which 35% are specifically ascribed to drugs. Annually, there are more than 100,000 outpatient visits for these diagnoses and about two million visits for immediate hypersensitivity reactions that may be due to drugs. Outpatient visits for drug eruptions and drug allergies that include a skin component exceed 500,000 annually. Conclusions Skin conditions often attributed to drugs are frequent reasons for hospitalization and physician visits. Optimal care of the individual patients with these conditions requires careful attention to drugs as a possible cause. Copyright © 2005 John Wiley & Sons, Ltd. [source] Introducing triage logic as a new strategy for the detection of signals in the WHO Drug Monitoring Database,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 6 2004M. Ståhl Abstract Purpose An important role for the WHO Programme for International Drug Monitoring is to identify signals of international drug safety problems as early as possible. The signal detection strategy, operated at the Uppsala Monitoring Centre (UMC), gave too many drug,adverse drug reaction (ADR) combinations for individual review. Therefore additional selection strategies were needed to improve the likely signal-to-noise ratio and for the UMC to complement the efforts of national centres in an efficient way. Methods The combinations database of the first quarter of 2001 was analysed using algorithms representing different strategies for finding relevant signals using triage logic. Results The strategies that together gave a manageable number of combinations, i.e. around 600, for further consideration in a single quarter were the algorithms for ,Rapid reporting increase', ,Serious reaction and new drug' and ,Special interests'. These filters began to be used routinely on the combinations database in late 2001. Conclusions While stressing that human review is essential, triage strategies are useful when attempting analysis of large amounts of data. By definition, the use of triage strategies may exclude some potential signals from consideration, although the intention is to improve the chances of detection by focussing on areas of greatest importance. Copyright © 2004 John Wiley & Sons, Ltd. [source] Adverse drug reactions and off-label prescribing for paediatric outpatients: a one-year survey of spontaneous reports in SwedenPHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 3 2004Mike Ufer MD Abstract Purpose To investigate the extent and characteristics of off-label prescribing for paediatric outpatients among drugs reported to have caused an adverse reaction. Methods A retrospective, cross-sectional, observational analysis of spontaneous adverse drug reaction (ADR) reports in Sweden in the year 2000. We included all reports concerning drugs prescribed for outpatients younger than 16 years. Each ADR was classified with respect to its causality, seriousness and type of reaction. Off-label prescribing was evaluated with respect to age, dose, indication, formulation and route and frequency of administration. Results We identified 112 patient-linked reports corresponding to 158 ADRs of which 31% were serious. Antiasthmatic drugs were most frequently suspected as a cause of almost every third adverse reaction. The average proportion of off-label drug prescribing amounted to 42.4%. It was more frequently associated with serious than non-serious ADRs and mostly due to a non-approved age or dose. The most common clinical manifestations were psychiatric disorders and mucocutaneous inflammatory reactions. Conclusions Off-label prescribing for paediatric outpatients is common among drugs reported to have caused an ADR. It is suggested to further identify unlabelled drugs frequently contributing to, in particular serious ADRs in children for a proper benefit-risk assessment of off-label drug use. Copyright © 2003 John Wiley & Sons, Ltd. [source] Proton pump inhibitor-induced acute interstitial nephritisBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 6 2007Linda Härmark What is already known about this subject ,,In several case reports the use of omeprazole has been associated with interstitial nephritis. ,,Recently there have been reports linking other proton pump inhibitors (PPIs) with interstitial nephritis. What this study adds ,,We present supplementary cases received by the Netherlands Pharmacovigilance Centre Lareb, concerning interstitial nephritis in users of PPIs including omeprazole, pantoprazole and rabeprazole. ,,In this case series seven patients are presented. In six cases they recovered spontaneously after cessation of the PPI, in one case the patient recovered after treatment with a corticosteroid. ,,Further support for this association comes from the worldwide adverse drug reaction database of the World Health Organization. ,,This report shows that interstitial nephritis can occur with all PPIs. Health professionals should be aware of this potential serious adverse drug reaction. Aim To investigate the association between the use of proton pump inhibitors (PPIs) and acute interstitial nephritis (AIN). Methods The Netherlands Pharmacovigilance Centre Lareb received seven case reports of AIN induced by various PPIs. In five of the reports it was mentioned that the diagnosis was confirmed by a renal biopsy. Results The time to onset varied between hours to 4 months. In all cases but one the patient spontaneously recovered after withdrawal of the offending agent. In one case the patient received treatment with prednisolone and recovered. In one patient a rechallenge was done 9 days after the initial event. Within 12 h of re-exposure the patient developed symptoms of AIN. Conclusions The mechanism of drug-induced AIN is unknown, but an immunological mechanism is suspected. Our reports show no relation between dosage, latency, time to recovery, age or gender, supporting the hypothesis that the aetiology of AIN is immunological. Lareb has received reports of AIN with the use of omeprazole, pantoprazole and rabeprazole. This shows that AIN is a complication associated with the whole group of PPIs and not only omeprazole. It is important for health professionals to be aware of this adverse drug reaction, because an accurate and timely diagnosis and withdrawal of the offending drug can prevent potentially life-threatening renal failure. [source] Clindamycin and taste disordersBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 4 2007Mark C. H. De Groot What is already known about this subject. ,,The antibiotic clindamycin has a bitter taste when it is used orally. What this study adds ,,A case series on oral as well as i.v. use of clindamycin associated with taste disorders is presented. ,,After corrections in a case-by-case analysis for several possible confounders such as indication, clindamycin is disproportionally associated with taste disorders. ,,Serum and hence saliva and sputum clindamycin levels seem to be responsible for this reversible adverse drug reaction. Aims Topical use of clindamycin has been associated with taste disorders in the literature, but little is known about the nature of this adverse drug reaction. The aim of this article was to describe reports of clindamycin-induced taste disorders and to analyse the factors involved. Methods The adverse drug reaction database of the Netherlands Pharmacovigilance Centre was searched for reports concerning taste disorders with antibiotics. Clinical review of the cases and statistical analysis with logistic regression were performed. Characteristics of patients who reported taste disorders were compared for age, gender and formulation in clindamycin vs. other antibiotic users. Results Taste disorders were reported in seven (18%) of the clindamycin cases. In five reports an oral formulation was involved, in one report intravenous (i.v.) administration and in one report both formulations were used. Latency was <1 day after start and in one case taste disorders were present repeatedly at 10 min after every i.v. application. The adjusted reporting odds ratio was 7.0 (95% confidence interval 2.8, 17.3) and supports a possible causal relationship. Conclusions The association of clindamycin and taste disorders is supported by disproportionality analysis and seems to be independent of possible confounders such as age, gender and infections. The case reports suggest a role for clindamycin concentrations excreted in body fluids like saliva. [source] Recording previous adverse drug reactions,a gap in the systemBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 6 2001Gillian M. Shenfield Aims, To measure the accuracy of recording of previous adverse drug reaction (ADR) history in patients admitted to a teaching hospital before and after an education programme. Methods, One month survey of patients on one medical and one surgical ward, repeated after a 1 month education programme. Patients answered a questionnaire about previous ADRs and this information was compared with that in all relevant sections of their medical records and medication charts. Results, Of 117 patients at baseline, 50 had a total of 81 previous ADRs. Only 75% were recorded on medication charts and 57% and 64%, respectively, in medical and nursing notes. In the post education survey of 124 patients, 56 had 105 previous ADRs, 85% were recorded on medication charts and 64% and 70% in medical and nursing records. These differences were not significant. Serious ADRs were also poorly recorded at baseline but, due to intervention by ward pharmacists, their recording on medication charts improved significantly after education. Pharmacists also significantly improved the quality of description of previous ADRs in both parts of the study. Conclusions, Previous ADR history obtainable from hospital patients is poorly recorded in medical records and an intensive education programme only produced a significant change in recording by ward pharmacists. Better strategies are needed to improve this essential aspect of history taking. [source] DRESS syndrome caused by efalizumabCLINICAL & EXPERIMENTAL DERMATOLOGY, Issue 1 2008J. M. L. White Summary We report a case of drug reaction with eosinophilia and systemic symptoms (DRESS) to efalizumab. A 52-year-old man developed a widespread papulovesicular rash after 4 weeks of treatment with efalizumab (1.0 mg/kg/week) for treatment-resistant severe psoriasis. Histology revealed a subepidermal blister with eosinophil-rich inflammatory cell infiltrate. Subsequently, the patient developed high peripheral eosinophilia, abnormal liver function, malaise and fever, all requiring inpatient admission. Efalizumab was discontinued immediately, but the rash persisted for 4 months and was only controlled by oral prednisolone at a dose of 30 mg/day. To our knowledge, this is the first reported case of DRESS caused by efalizumab. [source] Intranasal fentanyl in 1,3-year-olds: A prospective study of the effectiveness of intranasal fentanyl as acute analgesiaEMERGENCY MEDICINE AUSTRALASIA, Issue 5 2009Joanne Cole Abstract The primary objective of the present study was to determine the effectiveness of intranasal fentanyl analgesia in children aged 1,3 years with acute moderate to severe pain presenting to the ED. We also aimed to gather information on the safety and acceptability of intranasal fentanyl in this age group. Two paediatric ED enrolled children aged 1,3 years, with acute moderate or severe pain. Intranasal fentanyl was administered (1.5 µg/kg) via a mucosal atomiser device using a 50 µg/mL solution of fentanyl. Physiological parameters (heart rate, respiratory rate, oxygen saturations and level of consciousness) were measured at regular intervals. Objective pain assessment was completed using the Faces, Legs, Arms, Cry, Consolability (FLACC) score. Forty-six children presenting with acute moderate to severe pain were included. The median FLACC score before intranasal fentanyl administration was 8 (interquartile range [IQR] 5,10), decreasing to 2 (IQR 0,4) 10 min post fentanyl (P < 0.0001) and 0 (IQR 0,2) 30 min post fentanyl (P < 0.0001). A clinically significant decrease in FLACC scores was seen in 93% of children 10 min post fentanyl administration and 98% of children 30 min post fentanyl. Intranasal fentanyl delivery using a mucosal atomiser was well tolerated by all children. There were no adverse drug reactions or adverse events detected. Intranasal fentanyl is an effective, safe and well-tolerated mode of analgesia for children aged 1,3 years with moderate to severe pain. [source] Experience in adverse events detection in an emergency department: Nature of eventsEMERGENCY MEDICINE AUSTRALASIA, Issue 1 2007James Hendrie Abstract Objective:, The study was performed to determine the nature of adverse events in an ED. Methods:, The methodology has been described in the accompanying paper. Two by two tables were analysed using the two-tailed Fisher's exact test. A P -value of ,0.05 was considered significant. Statistical analysis was performed using MINITAB. Results:, One hundred and ninety-four events were detected, from a sample of 3222 patients. Except where specified, events with management causation ,3 were excluded. This excluded 24 events (12.4%) leaving 170 for analysis. Errors of commission occurred in 55% and omission in 45%. Errors of commission were significantly associated with prior events, errors of omission with ED events (P , 0.0001, respectively). The most common cause of events was drug reactions. 1.35% had a Naranjo score , 1, 0.54% , 4. Prior events were significantly associated with adverse drug reactions (P , 0.0001). Drug reactions were associated with a lower preventability score (P , 0.0001). Diagnostic issues were present in 1.2%. All three categories, that is diagnosis not considered, diagnosis within the differential and seriousness not appreciated were associated preventability ,4 (P , 0.0001, P , 0.02 and P , 0.004, respectively). Diagnostic problems were significantly associated with ED events (P , 0.0001). Conclusion:, In conclusion, the data demonstrate that events fall into two sets: prior events which are associated with errors of commission, drug reactions and lower preventability; and ED events which are associated with errors of omission, diagnostic issues and high preventability. [source] The clinical impact of pharmacogenetics on the treatment of epilepsyEPILEPSIA, Issue 1 2009Wolfgang Löscher Summary Drug treatment of epilepsy is characterized by unpredictability of efficacy, adverse drug reactions, and optimal doses in individual patients, which, at least in part, is a consequence of genetic variation. Since genetic variability in drug metabolism was reported to affect the treatment with phenytoin more than 25 years ago, the ultimate goal of pharmacogenetics is to use the genetic makeup of an individual to predict drug response and efficacy, as well as potential adverse drug events. However, determining the practical relevance of pharmacogenetic variants remains difficult, in part because of problems with study design and replication. This article reviews the published work with particular emphasis on pharmacogenetic alterations that may affect efficacy, tolerability, and safety of antiepileptic drugs (AEDs), including variation in genes encoding drug target (SCN1A), drug transport (ABCB1), drug metabolizing (CYP2C9, CYP2C19), and human leucocyte antigen (HLA) proteins. Although the current studies associating particular genes and their variants with seizure control or adverse events have inherent weaknesses and have not provided unifying conclusions, several results, for example that Asian patients with a particular HLA allele, HLA-B*1502, are at a higher risk for Stevens-Johnson syndrome when using carbamazepine, are helpful to increase our knowledge how genetic variation affects the treatment of epilepsy. Although genetic testing raises ethical and social issues, a better understanding of the genetic influences on epilepsy outcome is key to developing the much needed new therapeutic strategies for individuals with epilepsy. [source] | ||||||||||||||||||||||||||||||||||||||||