Editing Thalidomide (section)

===Leprosy treatment===
In 1964, Israeli physician [[Jacob Sheskin]] administered thalidomide to a patient critically ill with [[leprosy]]. The patient exhibited [[Erythema nodosum|erythema nodosum leprosum]] (ENL), a painful skin condition, one of the complications of leprosy. The treatment was attempted despite the ban on thalidomide's use, and the results were favourable: the patient slept for hours and was able to get out of bed without aid upon awakening. A clinical trial studying the use of thalidomide in leprosy soon followed.<ref name="Silverman">{{Cite journal |vauthors=Silverman WA |date=August 2002 |title=The schizophrenic career of a "monster drug" |journal=Pediatrics |volume=110 |issue=2 Pt 1 |pages=404–6 |doi=10.1542/peds.110.2.404 |pmid=12165600}}</ref>

Thalidomide has been used by Brazilian physicians as the drug of choice for the treatment of severe ENL since 1965, and by 1996, at least 33 cases of thalidomide embryopathy were recorded in people born in Brazil after 1965.<ref>{{Cite journal |vauthors=Castilla EE, Ashton-Prolla P, Barreda-Mejia E, Brunoni D, Cavalcanti DP, Correa-Neto J, Delgadillo JL, Dutra MG, Felix T, Giraldo A, Juarez N, Lopez-Camelo JS, Nazer J, Orioli IM, Paz JE, Pessoto MA, Pina-Neto JM, Quadrelli R, Rittler M, Rueda S, Saltos M, Sánchez O, Schüler L |date=December 1996 |title=Thalidomide, a current teratogen in South America |journal=Teratology |volume=54 |issue=6 |pages=273–7 |doi=10.1002/(SICI)1096-9926(199702)55:2<156::AID-TERA6>3.0.CO;2-1 |pmid=9098920 |doi-access=free}}</ref> Since 1994, the production, dispensing, and prescription of thalidomide have been strictly controlled, requiring women to use two forms of birth control and submit to regular pregnancy tests. Despite this, cases of thalidomide embryopathy continue,<ref>{{Cite journal |vauthors=Paumgartten FJ, Chahoud I |date=July 2006 |title=Thalidomide embryopathy cases in Brazil after 1965 |journal=Reproductive Toxicology |volume=22 |issue=1 |pages=1–2 |bibcode=2006RepTx..22....1P |doi=10.1016/j.reprotox.2005.11.007 |pmid=16427249}}</ref><ref>{{Cite web |date=January 2006 |title=Talidomida volta a assustar |trans-title=Thalidomide again scare |url=http://www.saude.df.gov.br/003/00301009.asp?ttCD_CHAVE=31041 |url-status=dead |archive-url=https://web.archive.org/web/20120313095445/http://www.saude.df.gov.br/003/00301009.asp?ttCD_CHAVE=31041 |archive-date=13 March 2012 |language=pt |vauthors=Braziliense C}}</ref> with at least 100 cases identified in Brazil between 2005 and 2010.<ref>{{Cite news |date=23 July 2013 |title=Brazil's new generation of Thalidomide babies |url=https://www.bbc.com/news/magazine-23418102 |url-status=live |archive-url=https://web.archive.org/web/20201110015129/https://www.bbc.com/news/magazine-23418102 |archive-date=10 November 2020 |access-date=21 June 2018 |work=BBC News |vauthors=Crawford A}}</ref> Nearly 6 million thalidomide pills were distributed throughout Brazil in this time period, and these cases have occurred despite the controls.<ref>{{Cite book | vauthors = Yasmin S |url=https://books.google.com/books?id=QrwLEAAAQBAJ&dq=million+thalidomide+Brazil&pg=PA132 |title=Viral BS: Medical Myths and Why We Fall for Them |date=2021-01-12 |publisher=JHU Press |isbn=978-1-4214-4041-5 |language=en}}</ref>

In 1998, the FDA approved the drug's use in the treatment of ENL.<ref name="nyt-fda">{{Cite news |date=17 July 1998 |title=Thalidomide Approved to Treat Leprosy, With Other Uses Seen |url=https://www.nytimes.com/1998/07/17/us/thalidomide-approved-to-treat-leprosy-with-other-uses-seen.html |url-status=live |archive-url=https://web.archive.org/web/20201203003055/https://www.nytimes.com/1998/07/17/us/thalidomide-approved-to-treat-leprosy-with-other-uses-seen.html |archive-date=3 December 2020 |access-date=8 January 2012 |work=New York Times |vauthors=Stolberg SG}}</ref> Because of thalidomide's potential for causing birth defects, the drug may be distributed only under tightly controlled conditions. The FDA required that [[Celgene Corporation]], which planned to market thalidomide under the brand name ''Thalomid'', establish a system for thalidomide education and prescribing safety (STEPS) oversight program. The conditions required under the program include limiting prescription and dispensing rights to authorized prescribers and pharmacies only, keeping a registry of all patients prescribed thalidomide, providing extensive patient education about the risks associated with the drug, and providing periodic pregnancy tests for women who take the drug.<ref name="nyt-fda" />

In 2010, the [[World Health Organization]] stated that it did not recommend thalidomide for leprosy due to the difficulty of adequately controlling its use, and due to the availability of [[clofazimine]].<ref>{{Cite web |last=Anon |title=Use of thalidomide in leprosy |url=https://www.who.int/lep/research/thalidomide/en/index.html |url-status=dead |archive-url=https://web.archive.org/web/20061110083549/http://www.who.int/lep/research/thalidomide/en/index.html |archive-date=10 November 2006 |access-date=22 April 2010 |website=WHO:leprosy elimination |publisher=WHO}}</ref>