Avandia and Actos to Include New Heart Failure Warnings

Lee Coleman

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The FDA announced yesterday that the diabetes drugs Avandia and Actos will be labeled with severe warnings of heart failure risk to some patients. The black box warnings are the most severe warnings that prescription drugs can get. These medicines may cause patients who already have heart failure to worsen, or cause heart failure in others.

The warnings, which the FDA said in June it would seek, are separate from concerns that Avandia also raises the risk of heart attack. FDA advisers said last month the risk appeared real but that the evidence wasn't conclusive enough to merit pulling Avandia from the market. They did recommend Avandia's label be updated to include information on that risk. The FDA said it was continuing its review of the issue.

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