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TZDs given black box warning on heart failure.(News)(thiazolidinediones)

Internal Medicine News

| September 01, 2007 | Mechcatie, Elizabeth | COPYRIGHT 2008 International Medical News Group. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

The labels of all thiazolidinediones will carry a black box warning about the risk of heart failure emphasizing that these drugs may "cause or exacerbate congestive heart failure in some patients," according to the Food and Drug Administration.

The agency sent the manufacturers letters requesting the change in May. Labeling for the thiazolidinediones (TZDs) rosiglitazone (Avandia), manufactured by GlaxoSmithKline, and pioglitazone (Actos), manufactured by Takeda, previously contained information about heart failure in the warnings and precautions sections. It is being strengthened as a result of concerns about rosiglitazone's cardiovascular safety.

The FDA…

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