WEDNESDAY, Aug. 15 (HealthDay News) -- The U.S. Food and Drug Administration has announced that thiazolidinediones must carry a "boxed" warning on the risk of heart failure. This represents an upgrade to the strongest form of warning required by the FDA and stems from a review of postmarketing adverse events associated with the diabetes drugs.
The whole class of thiazolidinedione drugs is affected, including Avandia (rosiglitazone), Actos (pioglitazone), Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepiride), manufactured by GlaxoSmithKline and Takeda.
Physicians are urged to be on the lookout for signs of heart failure among patients taking these drugs, including: excessive, rapid weight gain; shortness of breath; and edema. The warning also advises physicians not to prescribe the drug to patients with serious or severe heart failure.
"Under FDA's postmarketing surveillance program, we carefully monitor new safety information for marketed drugs and take appropriate action when necessary to inform patients and health care providers of new information," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research, in a statement. "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."
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