Health

Warnings added to labels of diabetes drugs

NEWS IN BRIEF — Posted Sept. 3, 2007

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A black-box warning will be added to the labels of type 2 diabetes drugs in the thiazolidinedione class, the Food and Drug Administration announced on Aug. 14.

The warning is needed because of the heightened risk of heart failure posed by the drugs, said the agency. The drugs affected include Avandia (rosiglitazone), Actos (pioglitazone), Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin) and Duetact (pioglitazone and glimepiride).

The new warning advises health care professionals to observe patients carefully for the signs and symptoms of heart failure.

This action is separate from an ongoing agency review of Avandia and its possible link to an increased risk of heart attacks. An FDA advisory committee recommended on July 30 that Avandia continue to be marketed but that an additional warning of heart attack be added to the label.

Note: This item originally appeared at http://www.ama-assn.org/amednews/2007/09/03/hlbf0903.htm.

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