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Potential Adverse Event (potential + adverse_event)
Selected AbstractsRhabdomyolysis with HMG-CoA reductase inhibitors and gemfibrozil combination therapy,,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2004Jennie T. Chang PharmD Abstract Context Elevated total cholesterol (total-C) and low-density lipoprotein cholesterol (LDL-C) levels are established risk factors for cardiovascular disease (CVD). HMG-CoA reductase inhibitors (statins) are effective cholesterol-lowering drugs that are commonly prescribed to treat this condition. These drugs are often combined with another class of drugs, fibric acid derivatives, to lower both cholesterol and triglyceride levels. Rhabdomyolysis is a known, rare serious side effect of statin monotherapy and of statin-fibrate combination therapy. Objective To examine Food and Drug Administration's (FDA's) postmarketing database for cases of rhabdomyolysis in relation to monotherapy and combination use and calculate reporting rates for this event. Design Domestic cases of statin- and statin/gemfibrozil-associated rhabdomyolysis were culled from FDA's database and reviewed. Rhabdomyolysis was defined by CPK,,,10,000 IU/L, myopathic signs and symptoms and clinical diagnosis of rhabdomyolysis. Reporting rates, consisting of number of reported cases/number of prescriptions for each drug, were then calculated to determine whether the reporting of rhabdomyolysis cases was commensurate with extent of use of each statin in the population. Setting Cases were obtained from the FDA adverse event reporting system (AERS) database. Patients NA. Main Outcome Measures Number of rhabdomyolysis cases were evaluated, along with outcomes, such as renal failure, dialysis and death. Results Of 866 total reported cases, 482 (56%) were associated with monotherapy and 384 (44%) related to combination therapy. More than 80% of reported cases for each drug resulted in hospitalization for renal failure and dialysis. 80 patients expired from events related directly to rhabdomyolysis. Reporting rates for all statins, except for cerivastatin, were similar and much lower than 1 per 100,000 prescriptions. The cerivastatin-reporting rate was much higher at 4.24/100,000 prescriptions. Conclusions Rhabdomyolysis is a rare, serious side effect of statin monotherapy and of statin-fibrate combination therapy. Clinicians need to remain cognizant of this potential adverse event and discuss signs and symptoms of muscle toxicity with patients in order improve the benefits-to-risks of treating dyslipidemia with statins. Copyright © 2004 John Wiley & Sons, Ltd. [source] Practical pharmacovigilance analysis strategiesPHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2003A. Lawrence Gould Abstract Purpose To compare two recently proposed Bayesian methods for quantitative pharmacovigilance with respect to assumptions and results, and to describe some practical strategies for their use. Methods The two methods were expressed in common terms to simplify identifying similarities and differences, some extensions to both methods were provided, and the empirical Bayes method was applied to accumulated experience on a new antihypertensive drug to elucidate the pattern of adverse-event reporting. Both methods use the logarithm of the proportional risk ratio as the basic metric for association. Results The two methods provide similar numerical results for frequently reported events, but not necessarily when few events are reported. Using a lower 5% quantile of the posterior distribution gives some assurance that potential signals are unlikely to be noise. The calculations indicated that most potential adverse event,drug associations that were well-recognized after 6 years of use could be identified within the first year, that most of the associations identified in the first year persisted over time. Other insights into the pattern of event reporting were also noted. Conclusion Both methods can provide useful early signals of potential drug,event associations that subsequently can be the focus of detailed evaluation by skilled clinicians and epidemiologists. Copyright © 2002 John Wiley & Sons, Ltd. [source] Ocular complications of neurological therapyEUROPEAN JOURNAL OF NEUROLOGY, Issue 7 2005S. Hadjikoutis Treatments used for several neurological conditions may adversely affect the eye. Vigabatrin-related retinal toxicity leads to a visual field defect. Optic neuropathy may result from ethambutol and isoniazid, and from radiation therapy. Posterior subcapsular cataract is associated with systemic corticosteroids. Transient refractive error changes may follow treatment with acetazolamide or topiramate, and corneal deposits and keratitis with amandatine. Intraocular pressure can be elevated in susceptible individuals by anticholinergic drugs, including oxybutynin, tolterodine, benzhexol, propantheline, atropine and amitriptyline, and also by systemic corticosteroids and by topiramate. Nystagmus, diplopia and extraocular muscle palsies can occur with antiepileptic drugs, particularly phenytoin and carbamazepine. Ocular neuromyotonia can follow parasellar radiation. Congenital ocular malformations can result from in utero exposure to maternally prescribed sodium valproate, phenytoin and carbamazepine. Neurologists must be aware of potential ocular toxicity of these drugs, and appropriately monitor for potential adverse events. [source] Causes of near misses in critical care of neonates and childrenACTA PAEDIATRICA, Issue 3 2008O Tourgeman-Bashkin Abstract Aim: The primary goal of this study was to examine the nature and causes of medical errors known as almost adverse events (AAEs) and potential adverse events (PAEs) in intensive care units. Methods: Observations were conducted in the Neonatal Intensive Care Unit and in the Pediatric Intensive Care Unit in a large hospital in Israel. The AAEs and PAEs were classified into three main categories: environmental, system and human factors. Data encoding and analysis was based on a Bayesian model previously developed to analyse causes of traffic accidents, and the categories were based on systems and ergonomics approaches. Results: ,Workload' (a system factor) was the main cause of AAEs and ,communication failures' (a human factor) was the second main cause of AAEs. Among the environmental factors, ,failures in medical devices' was the most cited cause of AAEs. Environmental factors accounted for most of PAEs and among them ,form failures' was the most ,AAE'-prone factor. Conclusions: Environmental factors (mainly ,failures in medical device') and system factors (mainly ,workload') accounted for most of AAEs in the intensive care units studied. The systems and the ergonomics approaches to error analysis can be useful in creating a comprehensive error management programme in order to minimize the gap between work demands and individual capabilities. [source] | ||||||||||