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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 victim, right; Sen. Kefauver and President-elect Kennedy, 1960 Associated Press and Joun Rous/Associated Press. A key provision of the new law made it a crime for drug companies to promote drugs to doctors for patients with illnesses for which the drug, according to its FDA-approved label, was not intended and approved for use.
Thalidomide is a known human teratogen and carries an extremely high risk of severe, life-threatening birth defects if administered or taken during pregnancy. [6] It causes skeletal deformities such as amelia (absence of legs and/or arms), absence of bones, and phocomelia (malformation of the limbs).
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]
During the late 1950s and early 1960s, doctors across the world routinely prescribed thalidomide to pregnant women in attempts to ease nausea. Unbeknownst to anyone taking or prescribing the new ...
Thalidomide was used as treatment for cancers, leprosy and HIV, however, the drug was extensively used for the treatment of nausea in pregnant women in the late 1950s and early 1960s until it became apparent in the 1960s that it resulted in severe birth defects.
McBride published a letter in The Lancet, in December 1961, noting a large number of birth defects in children of patients who were prescribed thalidomide, [9] after a midwife named Sister Pat Sparrow first suspected the drug was causing birth defects in the babies of patients under his care at Crown Street Women's Hospital in Sydney. [10]
This regulation was influenced by the results of 1950 use of thalidomide in Western Europe for pregnant women. They were prescribed the sedative thalidomide, which was inaccurately marketed as a morning sickness treatment. Women gave birth to more than 12,000 infants born with deformities due to effects from the drug in utero.