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Avandia and Actos Add "Black Boxes" for Heart Failure

As an interim step in its ongoing review of thiazolidinedione cardiac safety, the FDA has called for revised class labeling for the TZDs featuring strengthened warnings about the incidence of heart failure and contraindications for patients with existing heart failure.

The update to labeling for GlaxoSmithKline's Avandia (rosiglitazone) and Takeda's Actos (pioglitazone) includes the addition of a "black box" warning about the risk of heart failure with the type 2 diabetes drug, the FDA has announced. Previously, TZD labeling contained information about congestive heart failure in the Warnings and Precautions sections, but the FDA requested the strengthened warnings in May based on a review of post-market adverse event reports.

Recommendations and Considerations:

Thiazolidinediones, including Avandia, Avandamet, Avandaryl, Actos, Actoplus Met and Duetact, may cause or exacerbate congestive heart failure in some patients.

  • Initiation of these drugs in patients with established NYHA Class III or IV heart failure is contraindicated.
  • After initiation of Avandia, Avandamet, Avandaryl, Actos, Actoplus Met and Duetact, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema).
  • If these signs and symptoms develop and heart failure is confirmed, appropriate management of heart failure should be initiated. Discontinuation or dose reduction of Avandia, Avandamet, Avandaryl Actos, Actoplus Met and Duetact should be considered.