Glitazone safety assessment continues

Executive Summary

FDA is continuing to evaluate the safety of Warner-Lambert's Rezulin, SmithKline Beecham's Avandia and Lilly/Takeda's Actos "to more fully characterize the relative hepatic safety profile of these drugs." FDA noted that "comparative analyses remain preliminary" for the glitazones due to the short time Avandia and Actos have been on the market. "A definitive comparative hepatic safety conclusion has not been made by FDA at this time," the agency said in a statement. SB CEO-designate Jean-Pierre Garnier recently said that enough patients have been treated with Avandia and safety is no longer an issue. SB reports over 520,000 patients have been prescribed Avandia. Rezulin labeling was revised to recommend liver monitoring after use in 500,000 patients. According to IMS Health data, 309,000 Rezulin prescriptions, 268,000 Avandia prescriptions and 145,000 Actos prescriptions were written in January