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Heart Attack Risk Added to Avandia Labeling

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By Admin on November 14, 2007 10:36 AM

Labeling on the diabetes drug Avandia will now carry a boxed warning of increased heart attack risk, according to an Announcement from the U.S. Food and Drug Administration (FDA). The warnings will state that studies "have not confirmed or excluded" the risk of heart attack and chest pain associated with Avandia use, because data evaluated by the FDA shows that "there isn't enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments." In August 2007, FDA ordered that Avandia and other diabetes drugs carry "black box" warnings on the risk of heart failure associated with use of the drugs. Avandia is used by more than 2 million people to treat "type-2" or "adult-onset" diabetes, and is manufactured by GlaxoSmithKline.