FDA: No Decision on Whether to Pull Diabetes Drug Avandia Off the Market

Controversial medicine raises users' heart risk, leaked files suggest, but agency still reviewing data

By E.J. Mundell
HealthDay Reporter

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MONDAY, Feb. 22 (HealthDay News) -- The U.S. Food and Drug Administration on Monday said it was still reviewing documents that examine whether the blockbuster type 2 diabetes drug Avandia raises users' odds for heart attack and heart failure and should be removed from the market.

In an an agency statement, health officials said they are looking at data from a large, long-term clinical study known as RECORD to see if there are possible heart risks with rosiglitazone (Avandia), although they are also reviewing the results of several observational studies on the cardiovascular safety of Avandia.

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"These reviews are ongoing, and no new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time," the FDA statement said. "Once [the] FDA completes its review of the data from the RECORD study, the agency will present the totality of new and existing cardiovascular safety data on rosiglitazone at a public meeting in July 2010."

In the meantime, the agency said patients should still take Avandia unless their health-care professional tells them to stop.

On Saturday, The New York Times reported on documents from the U.S. Food and Drug Administration that found that if people now taking Avandia switched to a similar medication, Actos, about 500 heart attacks and 300 cases of heart failure would be eliminated each month. And in a report from the Institute for Safe Medication Practice, Avandia was linked to 304 deaths in the third quarter of 2009 alone, the highest for any prescribed drug in that time period, the Times reported.

In one of the FDA documents, dated October 2008, Drs. David Graham and Kate Gelperin -- drug safety officials at the agency -- agreed that "rosiglitazone should be removed from the market."

The reports, obtained early by the Times, are yet another chapter in Avandia's checkered history. The drug was once taken by millions worldwide, but that changed after a study released in early May of 2007 by the Cleveland Clinic suggested that Avandia carried cardiovascular risks. That study, which included more than 28,000 people, found that Avandia increased a user's odds of heart attack by 43 percent compared to those not taking the medicine.

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