Avandia Stays on Market
July 31, 2007
An FDA advisory committee found that GSK’s diabetes drug Avandia is tied to a risk of heart attacks, but did not vote to pull the medication off the market.
Several panel members said the drug should get a new heart-risk warning in its label.The nonbinding recommendation to the Food and Drug Administration came on a 22-1 vote by the panel.
The Panel offered different ideas for what, and where, the warning labels should appear. Some suggested a black box version that would focus on target groups of patients who appeared to be at higher risk. Other panel members didn’t specify what kind of warning label the FDA should support.
Congress has cited Glaxo’s Avandia as more evidence that the FDA’s is in need of an overhaul. They have been burdened by safety problems that emerge long after drugs win agency approval. The House and Senate are at work on legislation to do so.
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