FDA Reviewing Avandia, As Calls for Recall Mount

The Food & Drug Administration (FDA) announced yesterday that <"http://www.yourlawyer.com/topics/overview/avandia">Avandia is undergoing another review for heart attack risks. However, the agency advised patients now taking Avandia to continue doing so, even as the FDA came under increasing pressure to order Avandia off the market.

Avandia’s cardiovascular problems have been the subject of concern since May 2007, when an 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 FDA’s strongest safety warning – detailing Avandia’s association with myocardial ischemia was added to the drug’s labeling. Since the May 2007 study highlighting Avandia’s heart risks was released, thousands of people injured by the drug have filed lawsuits against Glaxo.

As we reported over the weekend, a two-year investigation of Avandia by the Senate Finance Committee found that in July 2007 the FDA’s own scientists estimated that Avandia was responsible for more than 80,000 heart attacks. According to the report, 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 included emails from GlaxoSmithKline officials and drew on interviews with Glaxo and FDA officials and anonymous whistleblowers.

According a notice posted on the FDA’s Web site, the agency is reviewing the primary data from a large, long-term clinical study, RECORD, on possible cardiovascular risks with Avandia. In addition to the clinical trial, the FDA said it has also been reviewing a number of observational studies of the cardiovascular safety of Avandia that have been published. The results of the review will be discussed at a public meeting in July, the FDA said.

According to a report in The Wall Street Journal, Glaxo released the results of RECORD last June, and said it showed there is no serious risk of heart attack or death from Avandia. However, in a conference call arranged Monday for health-care groups, FDA drug division leader Dr. Janet Woodcock said the results of RECORD were “at odds” with other studies that associated Avandia with heart attacks.

The Senate report released over the weekend said Glaxo was aware since at least 2004 that RECORD was statistically inadequate, or “underpowered.” Some doctors have also questioned whether RECORD was adequate enough to draw conclusions, The Wall Street Journal said.

Meanwhile, the FDA is under increasing pressure to remove Avandia from the market. According to the Journal, Rep. Rosa DeLauro (D., Conn.), the chairwoman of the House appropriations panel that controls the FDA’s budget, is the latest to call on the agency to do so. DeLauro said yesterday that it is “reprehensible that many people might have suffered heart attacks or heart failure as a result of taking this drug, especially if a safer alternative exists.”

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