The Final Word on TZD’s

Thiazolidinediones Receive Black Box For Heart Failure: Careful monitoring of patients advised.

The labels of all thiazolidinediones now carry a black box warning about the risk of heart failure. The strengthened warning emphasizes that thiazolidinediones (TZDs) may “cause or exacerbate congestive heart failure in some patients,” according to the FDA.

The agency sent the manufacturers letters requesting the labeling change in May. Product labeling for the TZDs rosiglitazone (Avandia), manufactured by GlaxoSmithKline, and pioglitazone (Actos), manufactured by Takeda, previously contained information about heart failure (HF) in the warnings and precautions sections, but the labeling is being strengthened following recent revelations about rosiglitazone’s cardiovascular safety.

The FDA says that the concern over heart failure is “separate” from the concerns over the increased MI risk associated with rosiglitazone, which was the subject of a joint meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee in July. The committees concluded then that data from meta-analyses of the rosiglitazone clinical program show an increased risk for myocardial ischemia for the type 2 diabetes therapy. The agency is currently reviewing similar pooled data from the pioglitazone clinical program.
“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,” Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research, said in an FDA statement.

Health care professionals are advised to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. The updated labeling states that initiation of rosiglitazone or pioglitazone, or the combinations that include these drugs, is contraindicated in patients with New York Heart Association class III or IV heart failure. After treatment with these products is initiated or after the dose is increased, patients should be carefully observed for signs and symptoms of heart failure. Patients who develop symptoms and are diagnosed with heart failure should receive appropriate treatment, and discontinuation or dose

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