We've known since 2007 that Avandia, once the world's most popular diabetes drug, may increase risk of stroke and heart attack. Two new studies further confirm the suspicions raised three years ago. The FDA plans to meet in July to finally decide whether or not to take Avandia off the market.
The larger of the two studies, commissioned by the FDA and published in the Journal of the American Medical Association, followed 230,000 Medicare patients who were taking either Avandia or a comparable drug called Actos. The results, study leader Dr. David Graham told NPR, indicate a frightening probability: "If you treated 60 people for a year with Avandia," he says, "you would cause one extra case of heart attack, stroke, heart failure or death compared to if you had treated 60 patients with Actos." By the same token, Graham says, approximately 100,000 Americans have likely died or had strokes, heart attacks or heart failure as a result of taking Avandia since it went on the market in 1999.
A meta-analysis of dozens of studies that came out in 2007 found the same results as these most recent studies, yet the FDA's Drug Safety Oversight Board voted 8-7 to keep Avandia on the market. What do you think? Has the FDA failed to learn the lesson posed by the Vioxx scandal in 2004? Or are they right to proceed with caution before pulling a product from the market?
