Manufacturers of certain drugs approved to treat type 2 diabetes have agreed to add an upgraded “boxed” warning emphasizing that the drugs may cause or worsen heart failure in certain patients.


FDA’s review of post-marketing adverse event reports found warning signs of heart failure, such as cases of significant weight gain and edema (FDA News, July 2007).

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The agency determined that a stronger warning on the risks was needed for the entire thiazolidinedione class of antidiabetic drugs, including Avandia (rosiglitazone), Actos (pioglitazone), Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepride).


“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,” said Steven Galson, MD, MPH, director of FDA’s Center for Drug Evaluation and Research.