West Germany withdraws thalidomide after birth defect epidemic

Chemie Grünenthal withdrew thalidomide from the West German market on November 26, 1961 after Dr. Widukind Lenz documented a sharp rise in babies born with phocomelia (limb deformities). The drug had been marketed as a safe sedative for pregnant women since 1957. Approximately 10,000 children in 46 countries were born with thalidomide-caused birth defects. FDA reviewer Dr. Frances Kelsey had already blocked U.S. approval, citing insufficient safety data, protecting the United States from the worst of the epidemic. The crisis directly triggered U.S. congressional action that led to the 1962 Kefauver-Harris Amendments requiring drug efficacy proof for the first time.