Glaxo Drug Gets Black Box

Updated from 5:33 p.m. EDT

The Food and Drug Administration said Tuesday that diabetes drugs from GlaxoSmithKline(GSK Quote - Cramer on GSK - Stock Picks) and Takeda Pharmaceutical will carry tough new warnings that alert patients to a higher risk of heart failure.

The so-called black box warnings affect Avandia from Glaxo -- which some researchers say increases the risk of heart attack -- and Actos from Takeda, whose clinical-trial results hadn't raised alarms like Glaxo's.

"This new boxed warning addresses FDA's concerns that despite the warnings and information already listed in the drug labels, these drugs are still being prescribed to patients without careful monitoring for signs of heart failure," said Dr. Steven Galson, director of the FDA's center for drug evaluation and research.

The FDA said it is continuing to assess if there is a link between Avandia and an higher chance of heart attacks.

The agency said its analysis of side effects for Avandia and Actos found "cases of significant" weight gain and fluid buildup, which are warning signs of heart failure. "In some reports ... continuation of therapy has been associated with poor outcomes, including death," the FDA said.

The new warnings come two weeks after a panel of medical advisers voted 20-3 that they believed Avandia raises the risk of a heart attack. But they also voted 22-1 that the drug remain on the market with stronger warnings.

The furor over Avandia started in May after the New England Journal of Medicine published research saying patients taking the drug had more potential for a heart attack than patients taking other pills to control blood sugar. Glaxo disputed the study's conclusions and methodology.

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