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Avandia increases heart risks, FDA says

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The Washington Post reports that popular diabetes drug Avandia has been shown to increase heart risks, according to an FDA study and a report published in a medical journal.

The study confirms that 60,000 to 100,000 reported heart attacks from Avandia users may be linked to the drug, which has been on the market for 8 years.

Avandia’s manufacturer GlaxoSmithKline PLC, a British company, has sold Avandia to more than 6 million people worldwide to treat Type 2 diabetes, which is the most common form of diabetes. Sales in the U.S. reportedly exceeded $2.2 billion last year.

On Monday, an analysis led by Cleveland Clinic cardiology chief Dr. Steven Nissen of 42 separate studies on Avandia concluded that it raised the risk of heart attacks by 43 percent, compared to the rates among people taking no or other diabetes drugs. The analysis also indicated that Avandia might increase the risk of heart-related deaths.

GlaxoSmithKline strongly disputes the conclusions. Company officials said that while their own similar analysis suggested a 31 percent greater risk _ information it shared with the FDA as early as 2005 _ more rigorous, albeit smaller, individual studies did not show that.