GlaxoSmithKline (GSK) has agreed to add a boxed warning about the risk of heart failure to the label of its Type 2 diabetes drug Avandia.

The FDA said that after reviewing postmarketing adverse event reports and finding cases of significant weight gain and edema – warning signs of heart failure – it decided that all Type 2 diabetes drugs in the thiazolidinedione class, such as Avandia (rosiglitazone maleate), require the warnings. According to some reports, “continuation of therapy has been associated with poor outcomes, including death,” the agency said.

“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,” Steven Galson, director of the FDA’s CDER, said.

The manufacturers, GSK and Takeda, agreed to add the warnings voluntarily. The other affected drugs are GSK’s Avandaryl (rosiglitazone maleate/glimepiride) and Avandamet (rosiglitazone maleate/metformin HCl), and Takeda’s Actos (pioglitazone HCl) and Duetact (pioglitazone HCl/glimepiride). These drugs are used in conjunction with diet and exercise to improve blood sugar control in adults with Type 2 (non-insulin-dependent) diabetes.

The strengthened warning advises healthcare professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive and 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 states.


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