Black-Box Heart-Failure Warning for Rosiglitazone, Pioglitazone

from Heartwire — a professional news service of WebMD

Shelley Wood

August 15, 2007

August 15, 2007 (Rockville, MD) - At the FDA's behest, GlaxoSmithKline and Takeda will be adding black-box warnings to their thiazolidinedione drugs for type 2 diabetes-- rosiglitazone (Avandia) and pioglitazone (Actos), respectively--reminding physicians that these drugs should not be used in people with heart failure, the FDA announced today [ 1]. The news is no surprise: FDA commissioner Andrew C von Eschenbach first promised this labeling change during a hearing of the US Congress House Committee on Oversight and Government Reform in June, as reported by heart wire .

But the recent brouhaha over rosiglitazone has had to do with risk of ischemic events, not heart failure, and an FDA press release states that the agency's "review of Avandia and the possible increased risk of heart attacks is ongoing." On July 30, a joint meeting of the FDA's Endocrine and Metabolic Advisory Committee and its Drug Safety and Risk Management Advisory Committee recommended that the FDA also include labeling about ischemic risk, noting that there is a signal of increased MI and cardiac death with the drug in some studies.

The heart-failure warning, however, merely strengthens the existing labeling caveats about use of this class of drugs in heart-failure patients. The boxed warning will now advise physicians to look carefully for heart-failure signs and symptoms, including edema, shortness of breath, and rapid weight gain. The warning will also appear on other brands made by these companies that combine rosiglitazone or pioglitazone with other antidiabetic agents.

  1. FDA. 2007 safety alerts for drugs, biologics, medical devices, and dietary supplements: Avandia (rosiglitazone maleate) tablets, Actos (pioglitazone hydrochloride) tablets, Avandaryl (rosiglitazone maleate and glimepiride) tablets, Avandamet (rosiglitazone maleate and metformin hydrochloride) tablets, Duetact (pioglitazone hydrochloride and glimepride) tablets. August 14, 2007. Available at: .

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