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The FDA has announced that some Type 2 diabetes drugs will be given a “black box” warning, which is the agency’s strongest warning, about the risk of heart failure. The upgraded warning states that the drugs may cause or worsen heart failure in certain diabetic patients.

After a review the FDA decided that the entire thiazolidinedione class of antidiabetic drugs needed the warning added to their labels. The drugs that will receive the warning include Avandia, Actos, Avandaryl, Avandamet ,and Duetact. The FDA has asked the manufacturers, GlaxoSmithKline and Takeda, to act upon its request.

“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, M.D., M.P.H., director of FDA’s Center for Drug Evaluation and Research.

The FDA’s review found cases where patients using these drugs incurred weight gain and edema, which are both signs of heart failure.

The strengthened warning advises health care professionals 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. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered.

The warning also lists that patients who have serious heart failure and who have marked limits on their activity should not use these drugs.

For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.

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