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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.
[10] [11] While it was initially thought to be safe in pregnancy, concerns regarding birth defects arose, resulting in its removal from the market in Europe in 1961. [9] [10] The total number of infants severely harmed by thalidomide use during pregnancy is estimated at over 10,000, possibly 20,000, of whom about 40% died around the time of birth.
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.
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]
For the first time in two decades, the Food and Drug Administration (FDA) has approved a new class of medication that provides an alternative to addictive opioids for patients looking to manage ...
Thalidomide — withdrawn in 1961 owing to widespread incidence of severe birth defects (phocomelia or tetraamelia) after prenatal use by pregnant women, US Food and Drug Administration approved thalidomide for erythema nodosum leprosum (ENL) in 1998, and 2008 for new cases of multiple myeloma (administered with dexamethasone). A large "off ...
Wonder Drug: The Secret History of Thalidomide in America and Its Hidden Victims is a nonfiction book authored by Jennifer Vanderbes and published by Random House in 2023. It tells the story of how Frances Oldham Kelsey of the Food and Drug Administration (FDA) found flaws in thalidomide research.