Thalidomide ( /θəˈlɪdəmaɪd/) is a sedative drug introduced in the late 1950s that was used to treat morning sickness and aid sleep. It was sold from 1957 until 1961, when it was withdrawn after being found to be a cause of birth defects. Modern uses of thalidomide (trademarked as Thalomid, according to FDA Orange Book) include treating multiple myeloma in combination with dexamethasone, and erythema nodosum leprosum, with strict controls on its use to prevent birth defects. Research is ongoing in its use to treat other cancers and autoimmune conditions, although its use is controversial; the thalidomide tragedy led to much stricter testing being introduced for drug and pesticide licensing.
Development Thalidomide was developed by German pharmaceutical company Grünenthal in Stolberg near Aachen. Heinrich Mückter, a former Nazi Party member and army physician was heading the research department since the start of the company and was responsible for inventing thalidomide. During the war he had been responsible at the German Supreme High Command institute for virus and typhus research in Cracow to produce Rudolf Weigl's vaccine against epidemic typhus.
Development Thalidomide, launched by Grünenthal on 1 October 1957, was found to act as an effective tranquilizer and painkiller, and was proclaimed a "wonder drug" for insomnia, coughs, colds and headaches. It was also found to be an effective antiemetic that has an inhibitory effect on morning sickness, so thousands of pregnant women took the drug to relieve their symptoms. At the time of the drug's development, scientists did not believe any drug taken by a pregnant woman could pass across the placental barrier and harm the developing fetus. The Food and Drug Administration of the United States never licensed thalidomide for general use; some of the birth defects caused by thalidomide in the United States were results of the drug being obtained from other countries. However, samples had been distributed to a number of physicians as part of a clinical trial, in which 20,000 patients in the U.S. received thalidomide.
Birth defects In the late 1950s and early 1960s, more than 10,000 children in 46 countries were born with deformities, such as phocomelia, as a consequence of thalidomide use. It is not known exactly how many worldwide victims of the drug there have been, although estimates range from 10,000 to 20,000.