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Avandia, Seroquel Have Most Adverse Event Report

Mar 5, 2010 | Parker Waichman LLP

Avandia’s cardiovascular problems have long been the subject of concern and controversy. Now, reports FiercePharma, an adverse event (AE) report for last year’s third quarter indicated that GlaxoSmithKline’s Avandia (generic: rosiglitazone) was number one on the list. The Institute for Safe Medication Practices issued the report.

The diabetes drug Avandia, was reported 1,218 times; 1,000 were serious or ended in death, said FiercePharma. Seroquel (generic: quetiapine), AstraZeneca’s antipsychotic medication, followed with 977 reports, according to FiercePharma. Lioresal (generic: baclofen), made by Novartis had 796 adverse event reports; fentanyl, a pain medication, 688; and Enbrel (generic: etanercept), manufactured by Amgen and Pfizer for rheumatoid arthritis and psoriasis, was cited 495 times. The report includes information from an array of sources and the Institute follows adverse event reports for some 2,000 medications, said FiercePharma.

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.

The Senate Finance Committee report was the result of a two-year investigation, and drew on 250,000 pages of documents, including emails from GlaxoSmithKline officials, as well as interviews with Glaxo and FDA officials and anonymous whistleblowers. According to the report, in July 2007 the FDA’s own scientists estimated that Avandia was responsible for more than 80,000 heart attacks. Two of the FDA’s own doctors wrote in an October 2008 memo that Avandia should be removed from the market because it poses serious heart-related dangers to patients, the report said.

The Senate report also claimed that Glaxo tried to undermine criticism of the drug: “GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.”

Since the release of the Senate report, calls have increased for the FDA to pull Avandia off the market.

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