Avandia Gets Black Box Warning Label

Shannon Weidemann

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The FDA has issued that the diabetes drug Avandia should carry a black box warning label for possible heart failure related to taking the drug. The warning labels will appear on all drugs in the thiazolidinedione class. GlaxoSmithKline is the manufacturer of Avandia.

"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.

Doctors are being asked to watch and test their patients carefully for signs of heart failure while on Avandia. Some patients have died of heart failure while on the drug.

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