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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 ...
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]
[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.
Thalidomide — withdrawn in 1961 owing to widespread incidence of severe birth defects (phocomelia or tetraamelia) after prenatal use by pregnant women, US Food and Drug Administration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 ...
In letters home from an abstinence-based facility in Prestonsburg, Kentucky, Kayla Haubner gushed about how she was taking to the program, but worried it wouldn’t be enough. “I’m so ready to stay sober,” she wrote in early 2013. “Believe me, I know how hard it’s gonna be when I leave here + go back into the real world. I’m safe ...
Rates of drug overdose deaths decreased in the United States for the first time since the COVID-19 pandemic began, according to new federal data published early Thursday. The rate of overdose ...
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.