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SmithKline Beecham Avandia

Executive Summary

FDA has received reports of hepatic adverse events including increased liver enzymes in patients treated with diabetes therapy rosiglitazone, but no cases resulted in death or liver transplant, FDA said following publication of articles on two reports of liver toxicity in Avandia-treated patients in the Jan. 18 Annals of Internal Medicine. SmithKline estimates 350,000 patients have taken Avandia since launch; the product passed the 1 mil. script mark in December. A four-year Diabetes Outcome Progression Trial (ADOPT) that will enroll more than 3,500 newly diagnosed patients to evaluate the long-term effects of Avandia on endpoints, including liver safety, has been initiated, SmithKline said. Hepatic AEs have also been reported in patients taking Takeda/Lilly's Actos (pioglitazone), FDA said, although the reports have not been fully analyzed. Actos and Avandia are part of the same glitazone class of diabetes therapies as Warner-Lambert's Rezulin (troglitazone), which has been associated with liver toxicity

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