Avandia is one of the most extensively researched diabetes medicines and has been studied in more than 50,000 patients.  The company has consistently shared data with the FDA and worked with the agency to update the label for Avandia as new data became available.

GSK's view remains that controlled clinical trials are the most rigorous form of scientific evaluation that can be used to assess the benefits and risks of medicines.  Results from six controlled clinical trials have been reported since the FDA last reviewed questions about the cardiovascular safety of Avandia in 2007.  Together, these trials show that Avandia does not increase the overall risk of heart attack, stroke or death.  As a result, we believe that when used in the appropriate patient and in accordance with labeling, Avandia is a safe and effective treatment option for type 2 diabetes.

"We would like to acknowledge the efforts made by the FDA to apply scientific rigour to the debate and understanding of the benefit-risk profile of Avandia," Strahlman concluded.

SOURCE GlaxoSmithKline