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GSK Believes There Is No Liver Safety Issue With AVANDIA; Responds to Public Citizen Petition
Date:10/30/2008

PHILADELPHIA, Oct. 30 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) today issued the following response to a petition filed by Public Citizen to the U.S. Food and Drug Administration (FDA) on AVANDIA(R) (rosiglitazone maleate), a highly effective therapy for treating type 2 diabetes when used in the appropriate patient population.

The safety of patients using our medicine is very important to us. On a continual basis, an external Hepatic Safety Board reviews any adverse event report received by GSK of liver failure, liver-related deaths and liver transplants for possible relationship to AVANDIA. As recently as July 2008, this panel of experts continued to endorse a favorable hepatic safety profile for AVANDIA.

Patients being treated with AVANDIA or other medicines to control blood sugar levels should remain on therapy, unless their doctor advises a different course of action.

AVANDIA has been shown to be a safe and highly effective treatment for type 2 diabetes for the appropriate patient. GSK strongly supports the safety and efficacy of AVANDIA based on extensive clinical trial experience and widespread post-marketing use. The record of safety and effectiveness of AVANDIA is backed by one of the largest clinical trial programs (including 52,000 patients) ever undertaken for any medicine.

Data from long-term clinical trials, which offer the most rigorous scientific measurement of safety and efficacy, provide substantial evidence to assess the benefit-risk of AVANDIA in treating patients with diabetes. Importantly, the Public Citizen petition did not include data from the current Prescribing Information for AVANDIA regarding ADOPT (A Diabetes Outcomes Progression Trial). ADOPT, the largest head-to-head diabetes trial, showed that AVANDIA sustained glycemic control longer than metformin or sulfonylurea, for up to five years. Additionally, outcomes from five long-term clinical studies did not demonstrate an increased risk of t
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SOURCE GlaxoSmithKline
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