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Subscribe To Our Syndicated NewsFDA Strengthens Warning on Avandia
-November 14, 2007
The U.S. Food and Drug Administration (FDA) recently strengthened the warnings for the diabetes drug Avandia.
The medication, produced by GlaxoSmithKline, has been linked to an increase in the risk of heart attacks in recent months.
Black Box Warning Added
The agency says that Avandia should remain on the U.S. market while the “safety assessment” continues.
The new black box warning is also going to apply to two other diabetes drugs from Glaxo, Avandamet and Avandaryl.
The warning was added to the existing black box warning, which indicates that the drug increases the risk for heart failure.
Avandia Questioned in the Past
Avandia became controversial last spring when Steven Nissen, a cardiologist from Cleveland Clinic, published an analysis on the 42 studies that had indicated the drugs risks.
Avandia was approved in 1999 to treat Type-2 diabetes.
Since its approval, the FDA has acknowledged a split within the agency regarding whether or not the medication should stay on the market.
(Source: Wall Street Journal)
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