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 WASHINGTON (AP) - The Food and Drug Administration will require tougher warnings about heart failure on the diabetes drugs Avandia and Actos, FDA Commissioner Andrew von Eschenbach said at a congressional hearing Wednesday.
Von Eschenbach revealed that the FDA is ordering GlaxoSmithKline to add a "black box" warning to Avandia and ordering Takeda Pharmaceuticals to do the same for its competing diabetes drug Actos, strengthening existing warnings about a condition in which the heart does not adequately pump blood. The issue is separate from an analysis in the New England Journal of Medicine that said Avandia increased the risk of heart attack.
The concerns about Avandia prompted some Democratic lawmakers to rebuke the Food and Drug Administration and call for increased regulation of the pharmaceutical industry.
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