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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).
In response to incidents such as difficulties with thalidomide the Kefauver-Harris Amendment was passed in 1962 as an amendment to the Federal Food, Drug, and Cosmetic Act. Kefauver-Harris required that all drugs approved for sale be proven safe and effective via rigorous scientific studies.
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]
Grünenthal became infamous in the 1950s and 1960s for the development and sale of the teratogenic drug thalidomide, marketed as the sleeping pill Contergan and promoted as a morning sickness preventive. Thalidomide caused severe birth defects, miscarriages, and other severe health problems.
At the White House, President Kennedy presented the President's Award for Distinguished Federal Civilian Service to Dr. Frances Oldham Kelsey, a reviewer for the U.S. Food and Drug Administration who successfully blocked the approval of the birth-defect causing drug thalidomide for American sale. [30]
The thalidomide molecule is a synthetic derivative of glutamic acid and consists of a glutarimide ring and a phthaloyl ring (Figure 5). [15] [16] Its IUPAC name is 2-(2,6-dioxopiperidin-3-yl)isoindole-1,3-dione and it has one chiral center [15] After thalidomide's selective inhibition of TNF-α had been reported, a renewed effort was put in thalidomide's clinical development.
One other major catastrophe occurred in the late 1950s when Thalidomide, which was originally sold in Germany (introduced into a virtually unregulated market) and eventually sold around the world, led to approximately 100,000 babies being born with various deformities. [4] In 1962 the United States Congress passed the Drug Amendments Act of ...