Thalidomide scandal

Phocomelia
Cases of severe thalidomide-induced phocomelia
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 by women who were pregnant or who subsequently became pregnant resulted in the "biggest anthropogenic medical disaster ever," with more than 10,000 children born with a range of severe deformities, such as phocomelia, as well as thousands of miscarriages.[1][2]

Thalidomide was introduced in 1953 as a tranquilizer, and was later marketed by the German pharmaceutical company Chemie Grünenthal under the trade name Contergan as a medication for anxiety, trouble sleeping, tension, and morning sickness.[3][4] It was introduced as a sedative and medication for morning sickness without having been tested on pregnant women.[5] While initially deemed to be safe in pregnancy, concerns regarding birth defects were noted in 1961, and the medication was removed from the market in Europe that year.[3][6]

  1. ^ Vargesson, Neil (June 2015). "Thalidomide-induced teratogenesis: history and mechanisms". Birth Defects Research Part C: Embryo Today: Reviews. 105 (2): 140–156. doi:10.1002/bdrc.21096. ISSN 1542-9768. PMC 4737249. PMID 26043938.
  2. ^ Bren L (28 February 2001). "Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History". FDA Consumer. U.S. Food and Drug Administration. Retrieved 23 December 2009.
  3. ^ a b Miller MT (1991). "Thalidomide Embryopathy: A Model for the Study of Congenital Incomitant Horizontal Strabismus". Transactions of the American Ophthalmological Society. 81: 623–674. PMC 1298636. PMID 1808819.
  4. ^ Loue S, Sajatovic M (2004). Encyclopedia of Women's Health. Springer Science & Business Media. pp. 643–644. ISBN 9780306480737.
  5. ^ Sneader W (2005). Drug discovery: a history (Rev. and updated ed.). Chichester: Wiley. p. 367. ISBN 978-0-471-89979-2.
  6. ^ Cuthbert A (2003). The Oxford Companion to the Body. Oxford University Press. p. 682. doi:10.1093/acref/9780198524038.001.0001. ISBN 9780198524038.