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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 ...
Adverse effects by frequency: [1] [2] Note that teratogenicity is not discussed here as it is not considered a side effect. For information regarding birth defects, see thalidomide .
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).
But it is known have developmental effects appear in fetuses and children even at very small doses. It has been shown to cause abnormal reflexes in neonates, poorer mental development in 2 and 3 year olds, poorer verbal IQ in 3 + 1 ⁄ 2 and 5 year old and pervasive developmental disorder in 2, 3 and 3 + 1 ⁄ 2 year olds. [20]
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]
Only 40% of these children survived. [8] Research also proves that although phocomelia did exist through the 1940s and 1950s, cases of severe phocomelia multiplied in the 1960s when thalidomide was released in Germany; the direct cause was traced to thalidomide. [9]
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]
Thalidomide: 1961 Germany Withdrawn because of risk of teratogenicity; [62] returned to market for use in leprosy and multiple myeloma under FDA orphan drug rules Thenalidine: 1963 Canada, UK, US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