The History of Thalidomide.

The first paper describing the pharmacological actions of thalidomide was published in 1956. The drug, then designated as K17, was thought to have sedative effects superior to those of comparator drugs and was thought to be virtually nontoxic. Only 2 years after thalidomide's launch as Contergan in Germany, it's alleged lack of toxicity came into question, with reports of the drug causing numerous side effects. Shortly thereafter, thalidomide was connected with an epidemic of horrific deformities in children whose mothers had taken the drug during pregnancy. This disaster brought on by thalidomide's teratogenic effects was responsible for the institution of some regulatory bodies, such as the United Kingdom's Committee on the Safety of Drugs, and for the strengthening of others, such as the U.S. Food and Drug Administration. An objective examination of published papers and contemporary accounts confirms that the preclinical tests on thalidomide were superficial, and there is no doubt that it was never administered to pregnant animals prior to its use in patients. Within a short time after its withdrawal from the market due to its suspected association with fetal abnormalities, the drug was shown to produce fetal toxicity in laboratory animals. Had there been more extensive testing on laboratory animals before the drug was launched, the disaster could have been avoided. (c) 2002 Prous Science. All rights reserved.