Avandia, Seroquel top adverse-event reports
26.02.10
An account of adverse event reports during 2009's third quarter shows that No. 1 on the list for the most AEs was GlaxoSmithKline's diabetes drug Avandia (rosiglitazone) with 1,218 reports--1,000 of which were serious or fatal. Avandia was recently cited in a U.S. Senate report, touching off a public argument over the drug's safety and Glaxo's conduct.
Second in line was AstraZeneca's antipsychotic drug Seroquel (quetiapine), with 977 reports; third came Novartis' Lioresal (baclofen) with 796. Rounding out the top five: The pain drug fentanyl with 688, and Amgen and Pfizer's rheumatoid arthritis and psoriasis treatment Enbrel (etanercept) with 495.
This ranking comes from the Institute for Safe Medication Practices and includes reports from a variety of sources. The institute tracks adverse reporting for almost 2,000 drugs, the vast majority of which saw very few. Fifty-seven drugs had 100 or more AEs reported during the quarter.
You'll note that this report of Avandia's AEs comes as debate heats up on the drug's safety. The Seroquel AE reports came in as AstraZeneca fought legal battles with plaintiffs alleging that the drug caused their diabetes. Both companies told the institute that the high number of reports probably stemmed from ongoing litigation over the drugs, and it's true that in the past, some drugs saw AE reports rise markedly after safety problems hit the news.
Source: FiercePharma
Avandia, Seroquel Have Most Adverse Event Report
05.03.10
We have long been following GlaxoSmithKline’s and Avandia’s controversy and legal woes. For instance, Avandia was recently cited in a U.S. Senate report, which sparked some debate about the drug maker’s activities and the medication’s safety. The release of the Senate Finance Committee report charged that the drug maker downplayed the drug’s heart risks. According to a prior Associated Press report, in a 30-page “white paper,” Glaxo claimed the Senate report “mischaracterizes and distorts” the company’s record.
Meanwhile, Avandia’s cardiovascular problems have been the subject of concern since May 2007, when a meta-analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. In November 2007, a black box warning—the Food & Drug Administration (FDA’s) strongest safety warning—detailing Avandia’s association with myocardial ischemia was added to the drug’s labeling.
Source: Newsinferno.com
美 아반디아·쎄로켈 등 부작용 '심각'
02.03.10
최근 미국에서 항당뇨제 ‘아반디아’(Avandia, rosiglitazone)와 정신질환 치료제 ‘쎄로켈’(Seroquel, quetiapine) 등 제품에 대한 중대한 부작용 보고가 가장 많았던 것으로 파악됐다.
미국 ISMP(Institute for Safe Medication Practices)는 미국 내에서 발생한 사망, 장애 등 중대한 약물 부작용에 대한 분기별 보고서를 통해 이같이 발표했다.
이에 따르면 최근 GSK의 아반디아에 대한 논란이 가중되고 있는 가운데, 2009년 3분기 동안에만 1218건의 중대한 부작용이 보고돼 최고로 많았다. 특히 아반디아에 대해서는 작년 1~3분기 동안 사망이 1000건 이상 보고됐는데, 대부분이 심혈관 원인으로 인한 것이었다.
다음으로는 아스트라제네카의 쎄로켈에 대해 977건이 보고됐는데 68%가 당뇨병에
Source: 디지틀보사