FDA panel in favor of keeping Avandia on the market

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Despite concerns that the popular GlaxoSmithKline diabetes drug Avandia could raise the risk for heart attack, a Food and Drug Administration (FDA) advisory panel voted today in favor of keeping the medication on the market. As the Wall Street Journal reports, 20 members of the 33-person panel voted in favor of keeping Avandia on the market, while 12 voted against and one abstained. Avandia is the trade name of rosiglitazone.

Critics of Avandia, including Dr. Steven Nissen, a cardiologist at the Cleveland Clinic and author of two studies assessing the drug’s risks, will likely be dismayed by the advisory committee decision. Nissen has been outspoken about his desire to yank the diabetes medication from pharmacy shelves, and his most recent meta-analysis of Avandia research, which included more than 35,000 patients, found that those taking the drug faced a 28% higher risk of heart attack compared with those taking a placebo or other form of diabetes medication.

Prior to today’s meeting, the FDA released a lengthy briefing document about the state of Avandia research which included harsh criticism of the major GlaxoSmithKline-funded study known as RECORD that has been used to defend the drug’s safety. In a memorandum dated June 14 of this year that is included in the briefing document, FDA reviewer Dr. Thomas Marciniak wrote:

“Our summary is that RECORD was inadequately designed and conducted to provide any reassurance about the [cardiovascular] safety of rosiglitazone. The results do confirm and extend the recognized concerns regarding increased heart failure and [heart failure] deaths with rosiglitazone.”

While the FDA advisory committee did vote to keep the drug on the market, concerns about its safety did prompt some to opt for stronger warning labels. As the Wall Street Journal reports, of the advisory committee members who voted in favor of keeping the drug on the market, seven voted in favor of stronger warnings, and 10 voted for both stronger warning labels and either greater limitation of distribution or increased doctor and patient education about the drug.

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