November 14, 2007
The government slapped a prominent, though confusing, warning on the popular diabetes drug Avandia on Wednesday _ telling patients that it may, or may not, increase the risk of heart attacks.The move is less stringent than steps Canada took last week to restrict the drug's use to hard-to-treat diabetics.
But the U.S. Food and Drug Administration concluded that studies are too contradictory to tell if Avandia really is riskier than other treatments for Type 2 diabetes.
So the FDA described the controversy in a black box on Avandia's label _ the most severe type of warning the agency can require _ pending further research. Unlike most black-box warnings that urge strong caution, Avandia's says, "The available data on the risk ... are inconclusive."
My doctor has switched all her patients off Avandia, from what she told me recently. I'd encourage anyone on the drug to seriously discuss the risks and benefits with their physician in order to make an informed decision.
Posted by: Greg at
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