FDA updates prescribing info for GSK's Avandia

7/15/2008

BRENTFORD, U.K. GlaxoSmithKline announced that the Food and Drug Administration has updated the prescribing information for its diabetes medication Avandia to include findings from the A Diabetes Outcome Progression Trial, according to published reports.

ADOPT is an international study on Avandia that demonstrated that patients treated with Avandia achieved greater sustained glycemic control compared to metformin and sulfonylurea, the ingredient in Aventis Pharmaceuticals’ Amaryl and Pfizer’s Glipizide. Better glycemic control has been proven to reduce risks of serious complications associated with Type 2 diabetes including blindness, loss of limbs and kidney failure, the company added.

This is key for the drug, which was given the black-box warning indication from the FDA last August after it was discovered that the drug might cause or worsen heart failure in some patients.

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