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Published on 16 August 2007

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FDA warns on Avandia and Actos


Two diabetes drugs in the USA are to carry severe health warnings about the risk of heart failure in some patients, the FDA has announced.

Avandia® (rosiglitazone) and Actos® (pioglitazone), which are both approved for use in the USA for treating type 2 diabetes, will feature “black box” warnings on the packaging – the strongest caution the FDA can sanction for prescription medications.

The alert points out that the medicines may cause or worsen heart failure and that patients taking them should be closely monitored.

Manufacturers GlaxoSmithKline and Takeda have agreed to the move.

Patients take the tablets, in conjunction with a healthy diet and regular exercise, to improve blood sugar control.

The warnings also apply to combinations of drugs that include the active ingredients found in the drugs, rosiglitazone and pioglitazone respectively.

Dr Steven Galson, director of the FDA’s Center for Drug Evaluation and Research, said: “Under FDA’s postmarketing surveillance program, we carefully monitor new safety information for marketed drugs and take appropriate action when necessary to inform patients and healthcare providers of new information.

“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.”

Copyright © PA Business 2007



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