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.
The controversy intensified when a medical expert told the House Committee on Oversight and Government Reform that executives threatened to sue him in 1999 when he first drew attention to heart attack risks linked to Avandia.
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