What was GlaxoSmithKline response to the studies?
Obviously, Avandia brings significant revenue to GlaxoSmithKline, they quoted in view of other studies published on Avandia that “Taken together, these trials show that Avandia does not increase the overall risk of heart attack, stroke or death.” What is the reaction of FDA regarding safety of Avandia? • In 2007, FDA advised Avandia to be on market in spite of the higher risk of heart attack and this advised was voted by an oversight board. The fact is now responsibility is on the FDA experts that approved the drug in the first place. FDA has a meeting on 13 and 14 July to decide fate of Avandia and Dr. Joshua M. Sharfstein, F.D.A.’s principal deputy commissioner, said in an interview that “these are two important papers that will be part of the discussion that F.D.A. has as we consider the important question of Avandia’s safety.” Dr. Sharfstein also said that “We need to split up the people who approve a drug from those who oversee its safety.” Diabetes affects a large population and
