Thalidomide

About Thalidomide

Thalidomide was marketed from 1957 as a sedative and was widely used by pregnant women for morning sickness. It was sold as Contergan in Germany and submitted for US approval as Kevadon. More than 10,000 children were born with phocomelia, a condition characterized by shortened or absent limbs. West Germany was most affected, with thousands of cases. The FDA reviewer Frances Kelsey declined to approve thalidomide in the United States, and is credited with preventing widespread harm there. For this she received the Presidents Award for Distinguished Federal Civilian Service from John F Kennedy. Thalidomide was withdrawn in 1961 after Widukind Lenz and William McBride independently identified the link. The tragedy led to the 1962 Kefauver Harris Amendment, strengthening FDA drug approval requirements including proof of efficacy and safety. Thalidomide has since been repurposed for complications of leprosy and for multiple myeloma under strict regulatory controls.