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FDA Advisory Committee Votes to Restrict Avandia

August 17th, 2010

In July 2010, a Food and Drug Administration advisory panel voted to recommend that the agency should withdraw or severely restrict the sale of Avandia due to its potential to increase the risk of heart attacks.

The panel’s votes came after two days of intense discussion in which members voiced skepticism about GlaxoSmithKline, the manufacturer of Avandia. The company was criticized throughout the meeting over repeated findings by federal officials that it had failed to conduct its Avandia studies properly. Dr. William Knowler, chief of diabetes epidemiology at the National Institute of Diabetes and Digestive Kidney Diseases, described one study conducted by GlaxoSmithKline as “totally incorrect and deceptive.”

Serious concerns about the safety of Avandia first arose in May 2007 as a result of a study published in the New England Journal of Medicine. The study found that Avandia users were 43% more likely to suffer a heart attack and 64% more likely to die of heart problems than patients taking a placebo.

Dr. Janet Woodcock, director of the FDA, said that the agency took the panel’s advice seriously and that it would consider its regulatory options, including whether to issue an Avandia recall.

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