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Thalidomide, sold under the brand ... with a request to market and distribute the drug in North America. ... discovered in 1994 that thalidomide inhibited ...
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 ...
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]
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.
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 ...
But the thalidomide story, along with persistent new reports about other drug company abuses, were highlighted in hearings convened by Senator Estes Kefauver, a Tennessee Democrat. This created a political climate for clamping down on the emerging pharmaceutical industry, and in 1962, President John F. Kennedy strengthened the landmark Federal ...
TIL that Thalidomide, the drug responsible for thousands of birth defects across Europe in the 1950s/60s, was developed by a doctor who had previously worked for the Nazis, experimenting on ...
Thalidomide: 1961 Germany Withdrawn because of risk of teratogenicity; [62] returned to market for use in leprosy and multiple myeloma under FDA orphan drug rules Thenalidine: 1963 Canada, UK, US Neutropenia [3] [63] Thiobutabarbitone: 1993 Germany Kidney injury. [3] Thioridazine (Melleril) 2005 Germany, UK