Thalidomide
From The Art and Popular Culture Encyclopedia
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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.
Birth defects
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.
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.
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. 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.
See also
