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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 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).
The directive was a reaction [citation needed] to the Thalidomide tragedy in the early 1960s, when thousands of babies were born with deformities as a result of their mothers taking the drug during pregnancy.
The thalidomide tragedy marked a turning point in toxicity testing, as it prompted United States and international regulatory agencies to develop systematic toxicity testing protocol. The effects of thalidomide led to important discoveries in the biochemical pathways of limb development. [ 6 ]
Thalidomide was once prescribed therapeutically from the 1950s to early 1960s in Europe as an anti-nausea medication to alleviate morning sickness among pregnant women. While the exact mechanism of action of thalidomide is not known, it is thought to be related to inhibition of angiogenesis through interaction with the insulin like growth ...
Additionally, informed consent became a participation requirement and rules were put into place. 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 ...
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]
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.