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Remove Diabetes Drug Avandia From Market: FDA Documents
Date:2/20/2010

Controversial medicine raises users' heart risk, leaked files suggest

SATURDAY, Feb. 20 (HealthDay News) -- The blockbuster type 2 diabetes drug Avandia raises users' odds for heart attack and heart failure and should be removed from the market, according to confidential government reports.

The New York Times on Saturday reported on documents from the U.S. Food and Drug Administration that find that if people now taking (rosiglitazone) 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.

At the time, Dr. Bruce M. Psaty of the University of Washington -- who also co-wrote an accompanying editorial in the New England Journal of Medicine -- urged the FDA to restrict access to Avandia and cited both the agency and the drug's maker, GlaxoSmithKline, for poor oversight.

"The primary problem here is that studies that were needed early on about the health benefits of this drug were never done," Psaty told HealthDay. "As a result of the failure of the
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