GSK updates Avandia labeling, based on FDA recommendations

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GlaxoSmithKline (GSK) has revised the U.S. prescribing information and medication guides for rosiglitazone-containing medicines (Avandia, Avandamet and Avandaryl) to include additional safety information and restrictions on the use of these medicines, reflecting the FDA’s review of cardiovascular event data in type 2 diabetes patients treated with Avandia.

This labeling change follows a meeting of the joint Advisory Committees in July 2010 and a decision in September 2010 by the FDA to restrict access to these medicines.

The revised labels restrict use to patients already taking a rosiglitazone-containing medicine or to new patients who are unable to achieve adequate glycemic control on other diabetes medications and to those, who in consultation with their healthcare provider, have decided not to take Actos (pioglitazone) or other pioglitazone-containing medicines for medical reasons. Patients should consult their healthcare professional for advice on the benefits and risks of Avandia.

A copy of the updated prescribing information in the U.S. for each rosiglitazone-containing medicine has been made available by the FDA ( Avandia label; Avandamet label; Avandaryl label).

As part of the September decision, the FDA had required GSK to establish a Risk Evaluation and Mitigation Strategy (REMS) program, which will restrict availability of these medicines. London-based GSK is working closely with the FDA to finalize the REMS program.

The FDA also had required an independent re-adjudication of the endpoints reported in the cardiovascular safety study RECORD. GSK continues to work to meet the FDA’s request.