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Chrissie Cole
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GSK Agrees to "Black Box" Warning for Avandia Heart Attack Risk

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Today, the U.S. Food and Drug Administration announced – GlaxoSmithKline (GSK), manufacturer of the popular type 2 diabetes drug, Avandia, has agreed to add new warning information to the existing boxed warning about the potential risk for heart attacks.

People who suffer from type 2 diabetes that have heart disease or who are at high risk of heart attack should talk with their medical doctor about the revised warnings. The FDA advises health care providers to closely monitor patients that take Avandia for cardiovascular risks.

On August 14, 2007, certain diabetes medications in the same class of drugs as Avandia, upgraded their warnings to emphasize that these types of drugs may increase the risk of heart failure in some patients.

Today’s action follows recommendations made at the July 2007 joint meeting of FDA’s Endocrine and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. At the meeting, members voted 22-1 to recommend that Avandia stay on the market, pending a review of additional data. The committee also advised that information warning of the potential for increased risk of heart attacks should be added to the drug labeling.

For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.