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Avandia Decision Looms for FDA

Jun 29, 2010 | Parker Waichman LLP


In two weeks, a U.S. Food & Drug Administration (FDA)  advisory panel will meet to discuss the safety of the controversial diabetes drug, Avandia. In the past,  the Avandia issue has sharply divided the agency.  However, over the past several years, concerns about Avandia side effects have only grown.

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. The black box was added after the Cleveland Clinic published a meta- analysis of 42 clinical trails that showed patients taking Avandia had a 43-percent higher risk of having a heart attack.

That black box didn't satisfy many Avandia critics, who wanted the drug pulled from the market.  But when it voted to require the stronger warning, the FDA's Drug Safety Oversight Board also voted 8-to-7 to keep Avandia on the market. That board does not meet in public, and it doesn't disclose its deliberations.

Earlier this year, the Senate Finance Committee released a report detailing its 2-year Avandia investigation. According to the report, in July 2007 the FDA’s own scientists estimated that Avandia was responsible for more than 80,000 heart attacks.

Since then, two new studies have been published pointing to Avandia heart risks.  One, conducted by the Cleveland Clinic's Dr. Steven Nissan, was an update to the 2007 study that sparked worry.  According to a report in the Wall Street Journal, Nissan’s updated analysis looked at 56 clinical studies involving 35,500 patients, including a Glaxo-funded study known as Record, and shows an increased heart attack risk of 28 percent. If the Record study is removed from the analysis, the risk of heart attacks rises to 39 percent, the Journal said.

The second study, conducted by Dr. David Graham of the FDA’s Center for Drug Evaluation and Research, found that patients in the U .S. Medicare system who took the drug may have suffered as many as 48,000 heart attacks, strokes and other problems between 1999 and 2009.  It involved 227,500 patients, making it the largest to date, and  found that patients who took Avandia were 27 percent more likely to suffer a stroke, 25 percent more likely to develop heart failure and 14 percent more likely to die compared with those who took Actos.

Both Nissan and Graham will present their findings at the public advisory panel meeting scheduled for July 13 and 14.  Both researchers have called for Avandia to be removed from the market.

They aren't the only ones with concerns about the drug.  The consumer advocacy group Public Citizen petitioned the FDA two years ago to remove Avandia from the market.  The American Diabetes Association and its European counterpart have advised doctors against using Avandia.

Dr. David Juurlink of the Institute for Clinical Evaluative Sciences in Ontario, who wrote an editorial for the Journal of the American Medical Association (JAMA) that accompanies the Graham and Nissan studies, recently told NPR that he thinks the accumulating evidence "make it difficult to advance a cogent argument regarding why, exactly, a patient might want to receive the drug or why a physician would choose to prescribe it."

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