Thalidomide

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Thalidomide is a sedative-hypnotic, and multiple myeloma medication. The drug is a potent teratogen in rabbits and primates including humans: this means that severe birth defects may result if the drug is taken during pregnancy.[2]

Thalidomide was developed by German pharmaceutical company GrĂ¼nenthal in Stolberg (Rhineland) near Aachen. It was sold from 1957 to 1961 in almost 50 countries under at least 40 names, including Distaval, Talimol, Nibrol, Sedimide, Quietoplex, Contergan, Neurosedyn, and Softenon. Thalidomide was chiefly sold and prescribed during the late 1950s and early 1960s to pregnant women, as an antiemetic to combat morning sickness and as an aid to help them sleep. Before its release, inadequate tests were performed to assess the drug’s safety, with catastrophic results for the children of women who had taken thalidomide during their pregnancies.

From 1956 to 1962, approximately 10,000 children in Africa and Europe were born with severe malformities, including phocomelia, because their mothers had taken thalidomide during pregnancy.[3]

The Australian obstetrician William McBride discovered the link between birth defects and the drug, and was awarded a medal and prize money by the prestigious L’Institut de la Vie in Paris.[4]

The impact in the United States was minimized when Frances Oldham Kelsey refused FDA-approval for an application from Richardson Merrell to market it saying it needed more study. Richardson Merrell gave the tablets to doctors with the understanding that it was still under investigation. 17 children in the U.S. were born with the defects.[5]

In 1962, the United States Congress enacted laws requiring tests for safety during pregnancy before a drug can receive approval for sale in the U.S.[6] Other countries enacted similar legislation, and thalidomide was not prescribed or sold for decades.

However, it was soon found that it was only one particular optical isomer of thalidomide which caused the teratogenicity. The pair of enantiomers, although mirror images of each other, cause different effects.[7]

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