Editing Emergency contraception (section)

====DES====
* In 1971, a ''[[New England Journal of Medicine]]'' editorial calling attention to previously published studies on the use of [[Diethylstilbestrol|DES]] as a postcoital contraceptive at [[Yale University]], and a large study published in ''[[Journal of the American Medical Association|JAMA]]'' on the use of DES as a postcoital contraceptive at the [[University of Michigan]], led to off-label use of DES as a postcoital contraceptive becoming prevalent at many university health services.<ref name="The morning-after pill"/><ref>{{cite journal | vauthors = Kuchera LK | title = Postcoital contraception with diethylstilbestrol | journal = JAMA | volume = 218 | issue = 4 | pages = 562–563 | date = October 1971 | pmid = 5171004 | doi = 10.1001/jama.218.4.562 }}</ref>
* In May 1973, in an attempt to restrict off-label use of DES as a postcoital contraceptive to emergency situations such as [[rape]], a ''FDA Drug Bulletin'' was sent to all U.S. physicians and pharmacists that said the FDA had approved, under restricted conditions, postcoital contraceptive use of DES.<ref>{{cite journal | vauthors = FDA | title = Selected items from the FDA drug bulletin-may 1973 | journal = California Medicine | volume = 119 | issue = 2 | pages = 87–88 | date = August 1973 | pmid = 18730987 | pmc = 1455105 }}</ref> (In February 1975, the FDA Commissioner testified that the only error in the May 1973 ''FDA Drug Bulletin'' was that the FDA had '''not''' approved postcoital contraceptive use of DES).<ref name="Kennedy hearing">{{cite book |author=U.S. Senate |year=1975 |title=Regulation of diethylstilbestrol (DES), 1975: Joint Hearing before the Subcommittee on Health and the Subcommittee on Administrative Practice and Procedure, 94th Congress, 1st Session on S. 963, February 27, 1975 |location=Washington |publisher=U.S. Govt. Print. Off}}</ref>
* In September 1973, the FDA published a proposed rule specifying patient labeling and special packaging requirements for any manufacturer seeking FDA approval to market DES as a postcoital contraceptive, inviting manufacturers to submit abbreviated [[new drug application]]s (ANDAs) for that indication, and notifying manufacturers that the FDA intended to order the withdrawal of DES 25&nbsp;mg tablets (which were being used off-label as postcoital contraceptives).<ref name=proposed73>{{cite journal |author=FDA |date=September 26, 1973 |title=Diethylstilbestrol. Use as postcoital contraceptive; patient labeling |journal=Fed Regist |volume=38 |issue=186 |pages=26809–11}}</ref><ref name="deslabel1975"/><ref name="des25mg1973">{{cite journal |author=FDA |date=September 26, 1973 |title=Certain estrogens for oral use. Notice of withdrawal of approval of new drug applications |journal=Fed Regist |volume=38 |issue=186 |pages=26824–6}}</ref>
* In late 1973, [[Eli Lilly and Company|Eli Lilly]], the largest U.S. manufacturer of DES, discontinued its DES 25&nbsp;mg tablets and in March 1974 sent a letter to all U.S. physicians and pharmacists telling them it did not recommend use of DES as a postcoital contraceptive.<ref name="Kennedy hearing"/>
* Only one pharmaceutical company, Tablicaps, Inc., a small manufacturer of [[generic drug]]s, ever submitted (in January 1974) an ANDA for use of DES as an emergency postcoital contraceptive, and the FDA never approved it.<ref name="Kennedy hearing"/><ref name="dutton">{{cite book |author=Dutton, Diana B. |year=1988 |title=Worse than the disease: pitfalls of medical progress |location=Cambridge |publisher=Cambridge University Press |isbn=978-0-521-34023-6 |url-access=registration |url=https://archive.org/details/worsethandisease0000dutt }}</ref>
* In February 1975, the FDA said it had not yet approved DES as a postcoital contraceptive, but would after March 8, 1975, permit marketing of DES for that indication in emergency situations such as rape or incest ''if'' a manufacturer obtained an approved ANDA that provided patient labeling and special packaging as set out in a FDA final rule published in February 1975.<ref>{{cite journal |author=FDA |date=February 5, 1975 |title=Diethylstilbestrol as postcoital oral contraceptive; patient labeling |journal=Fed Regist |volume=40 |issue=25 |pages=5351–5}}</ref> To discourage off-label use of DES as a postcoital contraceptive, in February 1975 the FDA ordered DES 25&nbsp;mg (and higher) tablets removed from the market and ordered the labeling of lower doses (5&nbsp;mg and lower) of DES still approved for other indications be changed to state: "THIS DRUG PRODUCT SHOULD ''not'' BE USED AS A POSTCOITAL CONTRACEPTIVE" in block capital letters on the first line of the physician prescribing information package insert and in a prominent and conspicuous location of the container and carton label.<ref name="deslabel1975">{{cite journal |author=FDA |date=February 26, 1975 |title=Estrogens for oral or parenteral use. Drugs for human use; drug efficacy study; amended notice |journal=Fed Regist |volume=40 |issue=39 |pages=8242}}</ref><ref name="des25mg1975">{{cite journal |author=FDA |date=February 5, 1975 |title=Certain estrogens for oral use or parenteral use. Drugs for human use; drug efficacy study implementation; follow-up notice |journal=Fed Regist |volume=40 |issue=25 |pages=5384}}</ref>
* In March 1978, a ''FDA Drug Bulletin'' was sent to all U.S. physicians and pharmacists which said: "FDA has not yet given approval for any manufacturer to market DES as a postcoital contraceptive. The Agency, however, will approve this indication for emergency situations such as rape or incest if a manufacturer provides patient labeling and special packaging. To discourage 'morning after' use of DES without patient labeling, FDA has removed from the market the 25 mg tablets of DES, formerly used for this purpose."<ref>{{cite journal |author=FDA |date=March–April 1978 |title=DES and Breast Cancer |journal=FDA Drug Bull |volume=8 |issue=2 |pages=10}}</ref>
* In the 1980s, off-label use of the Yuzpe regimen superseded off-label use of DES for postcoital contraception.<ref name="dutton"/><ref>{{cite book |author1=Hatcher, Robert A. |author2=Stewart, Gary K. |author3=Stewart, Felicia |author4=Guest, Felicia |author5=Schwartz, David W. |author6=Jones, Stephanie A. |year=1980 |title=Contraceptive Technology 1980–1981 |edition  =10th |location=New York |publisher=Irvington Publishers |isbn=978-0-8290-0084-9 |pages=128–33}}</ref><ref>{{cite book |author1=Hatcher, Robert A. |author2=Stewart, Gary K. |author3=Stewart, Felicia |author4=Guest, Felicia |author5=Josephs, Nancy |author6=Dale, Janet |year=1982 |title=Contraceptive Technology 1982–1983 |edition=11th |location=New York |publisher=Irvington Publishers |isbn=978-0-8290-0705-3 |pages=[https://archive.org/details/contraceptivetec0000hatc/page/152 152–7] |url=https://archive.org/details/contraceptivetec0000hatc/page/152 }}</ref>
** DES is no longer commercially available in the U.S.; Eli Lilly, the last U.S. manufacturer, ceased production in spring 1997.<ref>{{cite book |author1=Ibarreta, Dolores |author2=Swain, Shanna H. |year=2001 |chapter=The DES story: long-term consequences of prenatal use |editor1=in Harremoës, Poul |editor2=Gee, David |editor3=Vaz, Sofia Guedes |title=Late lessons from early warnings: the precautionary principle 1896–2000 |location=Copenhagen |publisher=European Environmental Agency |isbn=978-92-9167-323-0 |pages=84–92 |chapter-url=http://reports.eea.europa.eu/environmental_issue_report_2001_22/en/issue-22-part-08.pdf |access-date=2006-12-07 |archive-date=2006-11-21 |archive-url=https://web.archive.org/web/20061121032157/http://reports.eea.europa.eu/environmental_issue_report_2001_22/en/issue-22-part-08.pdf |url-status=dead }}</ref>