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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).
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.
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.
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 media identified her as "Mrs. Robert L. Finkbine" and "Sherri Finkbine", even though she personally did not use that name. [ 5 ] Following the paper's publication of Chessen's story, the hospital where she planned to have the abortion, wary of the publicity, sought assurance that it would not be prosecuted. [ 6 ]
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]