Drug Defects: February 2010 Archives

February 24, 2010

FDA Urges Avandia Recall, Diabetes Drug Linked to Heart Problems

The popular diabetes drug Avandia has been reported to cause hundreds of heart attacks each month and has also been linked to heart failure. According to a Senate report and as reported by The New York Times, the U.S. Food and Drug Administration (FDA) is urging a recall on Avandia because of the health risk associated with the drug. The reports state that heart failure and heart attacks suffered as a result of Avandia would be prevented if diabetes patients were instead given the drug Actos.

The Senate report says GlaxoSmithKline, the manufacturer of Avandia, was aware of Avandia's health risks for years but did not tell the public. In 2007, The Journal of the American Medical Association challenged Avandia's safety. The same year, a scientific study published in the New England Journal of Medicine showed a 43% higher risk of a heart attack from using Avandia. The pharmaceutical giant stood by its product, saying it was safe. Not too long after the study, the FDA added a black box warning of Avandia's heart attack risks.

Avandia (Rosiglitazone) has been on the market since 1999 for the treatment of Type 2 diabetes. GlaxoSmithKline continues to stand by its product, claiming there is no link between Avandia and heart attacks. However, the drug is estimated to have induced nearly 100,000 heart attacks in the 11 years it has been on the market.

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