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Feet of a baby born to a mother who had taken thalidomide while pregnant. In the late 1950s and early 1960s, the use of thalidomide in 46 countries was prescribed to women who were pregnant or who subsequently became pregnant, and consequently resulted in the "biggest anthropogenic medical disaster ever," with more than 10,000 children born with a range of severe deformities, such as ...
Thalidomide, sold under the brand names Contergan and Thalomid among others, is an oral medication used to treat a number of cancers (e.g., multiple myeloma), graft-versus-host disease, and many skin disorders (e.g., complications of leprosy such as skin lesions).
Frances Kathleen Oldham Kelsey CM (née Oldham; July 24, 1914 – August 7, 2015) was a Canadian-American [1] pharmacologist and physician. As a reviewer for the U.S. Food and Drug Administration (FDA), she refused to authorize thalidomide for market because she had concerns about the lack of evidence regarding the drug's safety. [2]
The U.S. Kefauver–Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval, [1] [2] required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed ...
The drug policy of the Philippines is guided by the Comprehensive Dangerous Drugs Act of 2002 and is implemented by the Dangerous Drugs Board with its implementing arm, the Philippine Drug Enforcement Agency along with other member agencies. Aside from regulating and prohibiting the usage, sale, production of certain drugs, the 2002 law is ...
On the history of the Contergan (thalidomide) catastrophe in the light of drug legislation, Dtsch Med Wochenschr. 2001 October 19;126(42):1183-6. Shah RR., Thalidomide, drug safety and early drug regulation in the UK, Adverse Drug React Toxicol Rev. 2001 Dec;20(4):199-255.
In 1946 Mückter became Head of Research at the Grünenthal pharmaceutical company, where he further developed the infamous drug thalidomide which had been synthesized in 1952 by Chemical Industry Basel. Aggressively-marketed as an over-the-counter sleeping pill and remedy for morning sickness in pregnancy, thalidomide was first made available ...
Widukind Lenz (4 February 1919, Eichenau, Bavaria – 25 February 1995) was a distinguished German pediatrician, medical geneticist and dysmorphologist who was among the first to recognize the thalidomide syndrome in 1961 and alert the world to the dangers of limb and other malformations due to the mother's exposure to this drug during pregnancy.