(FDA: Washington, D.C.) -- The U.S. Food and Drug Administration recently announced that manufacturers of certain drugs approved to treat Type 2 diabetes have agreed to add a stronger warning on the risk of heart failure, a condition that occurs when the heart does not adequately pump blood. The information will be included in the form of a "boxed" warning—FDA’s strongest form of a warning. The upgraded warning emphasizes that the drugs may cause or worsen heart failure in certain patients.After a review of postmarketing adverse event reports, FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs. This class includes Avandia (rosiglitazone), Actos (pioglitazone) Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepride). These drugs are used in conjunction with diet and exercise, to improve blood sugar control in adults with type 2 (noninsulin-dependent) diabetes. FDA had asked the drugs manufacturers, GlaxoSmithKline and Takeda, to address these concerns.

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