"Black Box" Warnings for Diabetes Drugs

By Admin on August 16, 2007 | Last updated on March 21, 2019

The U.S. Food and Drug Administration (FDA) announced that a number of diabetes drugs -- including Avandia -- will now carry "black box" warnings on the risk of heart failure associated with use of the drugs. The upgraded warning emphasizes that the drugs may cause or worsen heart failure in certain patients. The "black box" warning is FDA's strongest form of warning. FDA's review of Avandia and possible increased risk of heart attacks is ongoing. In late July 2007, an FDA advisory committee recommended that Avandia remain on the market despite evidence that use of the drug increases the risk of heart attacks. At that time, the panel advised the FDA that Avandia labeling should carry warnings of the increased risk of heart attack associated with the drug's use.

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