|
|
| (9 intermediate revisions by 3 users not shown) |
| Line 1: |
Line 1: |
| {{Redirect|EBC|the system for rating beer colour|European Brewery Convention}}<!--"colour" is not a misspelling, it's the correct British spelling--> | | __NOTOC__ |
| | '''For patient information, click [[Emergency contraception (patient information)|here]]''' |
| | |
| | {{Emergency contraception}} |
| | '''Editor(s)-in-Chief:''' [[C. Michael Gibson]], M.S.,M.D. [mailto:charlesmichaelgibson@gmail.com] Phone:617-632-7753; Angela Botts, M.D., Beth Israel Deaconess Medical Center Geriatric Medicine [mailto:abotts@bidmc.harvard.edu] |
| | |
| {{BirthControl infobox | | | {{BirthControl infobox | |
| | name = Emergency contraception | | | name = Emergency contraception |
| Line 22: |
Line 27: |
| | medical_notes = Combined estrogrogen/progestin pills of Yuzpe regimen now superseded by better tolerated and more effective progestin-only pill.<br/>ECP licensed for use within 3 days of unprotected intercourse and IUDs within 5 days. | | | medical_notes = Combined estrogrogen/progestin pills of Yuzpe regimen now superseded by better tolerated and more effective progestin-only pill.<br/>ECP licensed for use within 3 days of unprotected intercourse and IUDs within 5 days. |
| }} | | }} |
| {{wikinewspar|FDA to move on approval of over-the-counter sale of "Plan B" birth control}}
| |
|
| |
| '''Emergency contraception (EC)''', or emergency '''postcoital contraception''', refers to [[birth control|contraceptive]] measures that, if taken after [[sexual intercourse|sex]], may prevent pregnancy.
| |
|
| |
| Forms of EC include:
| |
| * Emergency contraceptive pills (ECPs)—sometimes simply referred to as emergency contraceptives (ECs) or the "'''morning-after pill'''"—are drugs that act both to prevent [[ovulation]] or [[fertilization]] and possibly post-fertilization [[Pregnancy|implantation]] of a [[blastocyst]] ([[embryo]]). ECPs are distinct from [[medical abortion]] methods that act after implantation.<ref>A minority view in the medical community, along with many [[pro-life]] advocates, argue for a [[Beginning of pregnancy controversy|different definition of pregnancy]]; see [[Emergency contraception#Controversy in relation to abortion|Controversy section]] for more detail.</ref>
| |
| * [[Intrauterine device]]s (IUDs)—usually used as a primary contraception method, but sometimes used as emergency contraception.
| |
|
| |
| As its name implies, EC is intended for occasional use, when primary means of contraception fail. Since EC methods act before implantation, they are medically and legally considered forms of [[contraception]]. Some [[pro-life]] groups define pregnancy as [[Beginning of pregnancy controversy|beginning with fertilization]], and consider EC to be an [[abortifacient]].
| |
|
| |
| == Emergency contraceptive pills (ECPs) ==
| |
| {{seealso|Emergency contraceptive availability by country}}
| |
| '''Emergency contraceptive pills''' (sometimes referred to as emergency hormonal contraception (EHC) in the U.K.) may contain higher [[dose]]s of the same [[hormone]]s ([[estrogen]]s, [[progestin]]s, or both) found in regular [[combined oral contraceptive pill]]s. Taken after [[unprotected sex|unprotected sexual intercourse]], such higher doses may prevent pregnancy from occurring. [[Mifepristone]] is another kind of ECP, but is considered an anti-hormonal drug, and does not contain estrogen or progestins.
| |
|
| |
| The phrase "morning-after pill" is figurative; ECPs are licensed for use up to 72 hours after sexual intercourse.
| |
|
| |
| ===Types of ECPs===
| |
| The '''progestin-only''' method uses the progestin [[levonorgestrel]] in a dose of 1.5 mg, either as two 750 μg doses 12 hours apart, or more recently as a single dose. Progestin-only EC is available as a dedicated emergency contraceptive product under many names worldwide, including: in the U.S., Canada and Honduras as ''Plan B''; in the U.K., Ireland, Australia, New Zealand, Portugal and Italy as ''Levonelle''; in 44 nations including France, most of Western Europe, India, and several countries in Africa, Asia and Latin America as ''NorLevo''; and in 44 nations including most of Eastern Europe, Mexico and many other Latin American countries, Portugal, Australia and New Zealand, Israel, China, Hong Kong, Taiwan and Singapore as ''Postinor-2''.<ref name="ecp worldwide">{{cite web |author=Trussell, James; Wynn, Lisa |date=2007-06-28 |title=Emergency Contraceptive Pills Worldwide |url=http://ec.princeton.edu/questions/dedicated.html |publisher=[[Princeton University]] |accessdate=2007-06-30}}</ref>
| |
|
| |
| The '''combined''' or [[Yuzpe regimen]] uses large doses of both estrogen and progestin, taken as two doses at a 12-hour interval. This method is now believed to be less effective and less well-tolerated than the progestin-only method.<!--
| |
| --><ref name="who 1998">{{cite journal |author=[[World Health Organization|WHO]] Task Force on Postovulatory Methods of Fertility Regulation |year=1998 |title=Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception |journal=[[The Lancet|Lancet]] |volume=352 |issue=9126 |pages=428-33 |id=PMID 9708750}}</ref>
| |
| It is possible to obtain the same dosage of hormones, and therefore the same effect, by taking several regular combined [[oral contraceptive formulations|oral contraceptive pills]]. For example, 4 [[Ovral]] pills are the same as 4 Preven pills.<ref name="ecp US brands">{{cite web |author=OPR & ARHP |date=2007-06-18 |title=Emergency contraception: Pill brands, doses, and instructions |url=http://ec.princeton.edu/questions/dose.html |publisher=[[Princeton University]] |accessdate=2007-06-30}}</ref><ref>{{cite web |author=OPR & ARHP |date=2007-06-18 |title=Ovral |url=http://ec.princeton.edu/pills/ovral.html |publisher=[[Princeton University]] |accessdate=2007-06-30}}</ref> The FDA approved this off-label use of certain brands of regular combined oral contraceptive pills in 1997.<ref name="ecp US brands"/><ref name="fr 1997">{{cite journal |author=FDA |date=1997-02-25 |title=Certain combined oral contraceptives for use as postcoital emergency contraception |journal=Fed Regist |volume=62 |issue=37 |pages=8610-2}}</ref><ref name="ppfa ec">{{cite web |author=Weiss, Deborah; Friedman, Deborah |date=2006-12-13 |title=Emergency contraception |url=http://www.plannedparenthood.org/news-articles-press/politics-policy-issues/birth-control-access-prevention/emergency-contraception-6549.htm |publisher=[[PPFA]] |accessdate=2007-06-30}}</ref>
| |
|
| |
| The drug '''[[mifepristone]]''' may be used either as an ECP or as an abortifacient, depending on whether it is used before or after implantation. In the USA, it is most commonly used in 200- or 600-mg doses as an abortifacient,<ref>{{cite web | title=Planned Parenthood - Mifepristone: Expanding Women's Options for Early Abortion | url=http://www.plannedparenthood.org/pp2/portal/files/portal/medicalinfo/abortion/fact-early-abortion-mifepristone.xml | accessmonthday=July 23 | accessyear=2006}}</ref> but in [[China]] it is commonly used as emergency contraception. As EC, a low dose of mifepristone is slightly less effective than higher doses, but has fewer side effects.<ref>{{cite journal|author=Piaggio G et al|title=Meta-analysis of randomized trials comparing different doses of mifepristone in emergency contraception|journal=Contraception|year=2003|volume=68|issue=6|id=PMID 14698075}}</ref> As of 2000, the smallest dose available in the USA was 200 mg.<ref>{{cite journal | last = Wertheimer | first = Randy E. | title = Emergency Postcoital Contraception | journal = American Family Physician | date = [[2000-11-15]] | publisher = American Academy of Family Physicians | url = http://www.aafp.org/afp/20001115/2287.html | format = [[HTML]] | accessdate = 2006-07-23}}</ref> Mifepristone, however, is not approved for emergency contraceptive use in the United States.<ref>Ho, Pak Chung, et. al (2002)."Mifepristone: Contraceptive and Non-Contraceptive Uses." Current Opinions in Obstetrics Gynecology, 14(3), 325-230.</ref> A review of studies in humans concluded that the contraceptive effects of the 10-mg dose are due to its effects on ovulation,<ref>{{cite journal | last = Gemzell-Danielsson | first = K. | coauthors = Marions, L. | title = Mechanisms of action of mifepristone and levonorgestrel when used for emergency contraception | journal = Human Reproduction Update | volume = 10 | issue = 4 | pages = 341-348 | date = [[2004-06-10]] | publisher = Oxford University Press | url = http://humupd.oxfordjournals.org/cgi/content/abstract/10/4/341|format = [[HTML]] | accessdate = 2006-07-23}}</ref> but understanding of its mechanism of action remains incomplete. Higher doses of mifepristone can disrupt implantation and, unlike levonorgestrel, mifepristone is effective in terminating established pregnancies.
| |
|
| |
| Morning-after pills (ECPs) are not to be confused with the “abortion pill”, otherwise known as RU486, mifestone, or Mifeprex. According to the International Federation of Gynecology and Obstetrics, “EC is not an abortifacient because it has its effect prior to the earliest time of implantation.” Since they act before implantation, they are considered medically and legally to be forms of contraception.
| |
|
| |
| ===Effectiveness of ECPs===
| |
| '''Progestin-only (levonorgestrel) regimen''':
| |
| :The original (1999) FDA-approved U.S. product labeling for Plan B said: <blockquote>Plan B reduces the risk of pregnancy following a single act of unprotected sex from about 8% down to 1%. This represents an 89% reduction in risk of pregnancy for this single act of unprotected sex.<ref name="Plan B 1999">{{cite web |author=[[Food and Drug Administration|FDA]] |month=July 29, |year=1999 |title=Plan B label information |url=http://www.fda.gov/cder/foi/label/1999/21045lbl.pdf |accessdate=2007-07-03}}</ref></blockquote>
| |
| :The current (2006) FDA-approved U.S. product labeling for Plan B says: <blockquote>Plan B works best the sooner you use it. If it is taken within 72 hours (3 days) after sex, it will significantly decrease the chance that you will get pregnant. Seven out of every 8 women who would have gotten pregnant will not become pregnant. Plan B works even better than this if taken within the first 24 hours after sex.<ref name="Plan B 2006">{{cite web |author=[[Food and Drug Administration|FDA]] |month=August 24, |year=2006 |title=Plan B label information |url=http://www.fda.gov/cder/foi/label/2006/021045s011lbl.pdf |accessdate=2007-07-03}}</ref></blockquote>
| |
|
| |
| '''Combined (Yuzpe) regimen''':
| |
| :The original (1998) FDA-approved U.S. product labeling for Preven (the Yuzpe regimen), referring to Yuzpe regimen ECPs, said: <blockquote>If one hundred women used ECPs correctly in one month, about two women would become pregnant after a single act of intercourse. If no contraception is used about eight women would become pregnant after a single act of intercourse. Therefore, the use of ECPs results in a 75% reduction in the number of pregnancies to be expected if no ECPs were used after unprotected intercourse. Notably some clinical trials have shown that efficacy was greatest when ECPs were taken within 24 hours of unprotected intercourse, decreasing somewhat during each subsequent 24-hour period.<ref name="Preven 1998">{{cite web |author=[[Food and Drug Administration|FDA]] |month=September 1, |year=1998 |title=Preven label information |url=http://www.fda.gov/cder/foi/label/1998/20946lbl.pdf |accessdate=2007-07-03}}</ref>
| |
| </blockquote>
| |
| : The effectiveness of emergency contraception is expressed as a percentage reduction in pregnancy rate for a single use of EC. A review article in ''[[American Family Physician]]'' explains the 75% effectiveness rate of the Yuzpe regimen thus: <blockquote>... these numbers do not translate into a pregnancy rate of 25 percent. Rather, they mean that if 1,000 women have unprotected intercourse in the middle two weeks of their menstrual cycles, approximately 80 will become pregnant. Use of emergency contraceptive pills would reduce this number by 75 percent, to 20 women.<ref name="weismiller">{{cite journal |author=Weismiller D |year=2004 |title=Emergency contraception |journal=Am Fam Physician |volume=70 |issue=4 |pages=707-14 |id=PMID 15338783 |url=http://www.aafp.org/afp/20040815/707.html}}</ref></blockquote>
| |
|
| |
| '''Mifepristone regimen''':
| |
| :In three randomized trials providing individual data of mifepristone 10 mg taken up to 120 hours (5 days) after intercourse, the combined estimate of pregnancies prevented was 83%.<!--
| |
| --><ref name="piaggio 2003">{{cite journal|author=Piaggio G, Heng Z, von Hertzen H, Bilian X, Linan C |year=2003 |title=Combined estimates of effectiveness of mifepristone 10 mg in emergency contraception |journal=Contraception |volume=68 |issue=6 |pages=439-46 |id=PMID 14698074}}</ref> In high quality trials, mifepristone 10 mg had similar effectiveness to mifepristone 25-50 mg, which had similar effectiveness to levonorgestrel 1.5 mg.<!--
| |
| --><ref name="cheng 2004">{{cite journal|author=Cheng L, Gulmezoglu AM, Oel CJ, Piaggio G, Ezcurra E, Look PF |year=2004 |title=Interventions for emergency contraception |journal=Cochrane Database Syst Rev |volume= |issue=3 |pages=CD001324 |id=PMID 15266446 |url=http://www.cochrane.org/reviews/en/ab001324.html}}</ref><!--
| |
| --><ref name="who 2002">{{cite journal |author=von Hertzen H, Piaggio G, Ding J, Chen J, Song S, Bartfai G, Ng E, Gemzell-Danielsson K, Oyunbileg A, Wu S, Cheng W, Ludicke F, Pretnar-Darovec A, Kirkman R, Mittal S, Khomassuridze A, Apter D, Peregoudov A; WHO Research Group on Post-ovulatory Methods of Fertility Regulation |year=2002 |title=Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial |journa=[[The Lancet|Lancet]] |volume=360 |issue=9348 |pages=1803-10 |id=PMID 12480356}}</ref>
| |
|
| |
| The effectiveness of emergency contraception is highest when taken within 12 hours of intercourse and declines over time.<!--
| |
| --><ref>{{cite journal |author= |year=1999 |title=Counsel women to take ECPs as soon as possible |journal=Contracept Technol Update |volume=20 |issue=7 |pages=75-7 |id=PMID 12295381}}</ref><!--
| |
| --><ref name="who 1999">{{cite journal |author=[[World Health Organization|WHO]]/HRP |year=1999 |title=Levonorgestrel is more effective, has fewer side-effects, than Yuzpe regimen |journal=Prog Hum Reprod Res |volume= |issue=51 |pages=3-5 |id=PMID 12349416 |url=http://www.who.int/reproductive-health/hrp/progress/51/news51_1.en.html#2}}</ref>
| |
| The limit of 72 hours is based on a study by the [[World Health Organization]] (WHO).<!--
| |
| --><ref name="who 1998"/>
| |
| A subsequent WHO study has suggested that reasonable effectiveness continues for up to 120 hours (5 days) after intercourse.<!--
| |
| --><ref name="who 2002"/>
| |
| However, many doctors (particularly in the U.K.) advise use of an IUD rather than ECPs for emergency contraception between 72 and 120 hours.{{Fact|date=July 2007}}
| |
|
| |
| ====Effectiveness estimate calculation====
| |
| Early studies of emergency contraceptives did not attempt to calculate a failure rate, they simply reported the number of women who became pregnant after using an emergency contraceptive. Since 1980, clinical trials of emergency contraception have estimated effectiveness using: observed pregnancies divided by the estimated (by cycle day) number of women who would have become pregnant without treatment.<!--
| |
| --><ref>{{cite journal|author=Dixon GW, Schlesselman JJ, Ory HW, Blye RP |title=Ethinyl estradiol and conjugated estrogens as postcoital contraceptives |journal=JAMA |year=1980 |volume=244 |issue=12 |pages=1336-9 |id=PMID 6251288}}</ref>
| |
|
| |
| In their April 2007 emergency review article, Trussell and Raymond note:
| |
| <blockquote>Calculation of effectiveness, and particularly the denominator of the fraction, involves many assumptions that are difficult to validate. Therefore, reported figures on the efficacy of emergency contraception may be underestimates or, more probably, overestimates. Yet, precise estimates of efficacy may not be highly relevant to many women who have had unprotected intercourse, since ECPs are often the only available treatment. A more important consideration for most ECP clients may be the fact that data from both clinical trials and mechanism of action studies clearly show that at least the levonorgestrel regimen of ECPs is more effective than nothing.<ref name="trussell 2007"/></blockquote>
| |
| * Eight studies of the progestin-only (levonorgestrel) regimen, that included more than 9,500 women, reported effectiveness estimates between 59% and 94%.<!--
| |
| --><ref name="trussell 2007">{{cite web |author=Trussell J, Raymond EG |month=April |year=2007 |title=Emergency contraception: a cost-effective approach to preventing unintended pregnancy |publisher=[[Princeton University]] |url=http://ec.princeton.edu/questions/ec-review.pdf |accessdate=2007-07-03}}</ref>
| |
| * A meta-analysis of eight studies of the combined (Yuzpe) regimen, that included more than 3,800 women and reported effectiveness estimates between 56% and 89%, concluded that the best point estimate of effectiveness was 74%.<!--
| |
| --><ref name="trussell 2007"/><!--
| |
| --><ref name="trussell 1999">{{cite journal |author=Trussell J, Rodriguez G, Ellertson C |year=1999 |title=Updated estimates of the effectiveness of the Yuzpe regimen of emergency contraception |journal=Contraception |volume=59 |issue=3 |pages=147-51 |id=PMID 10382076}}</ref>
| |
| * A more recent analysis of two of the largest combined (Yuzpe) regimen studies, using possibly more accurate estimates of conception probabilities by cycle day, found effectiveness estimates of 47% and 53%.<!--
| |
| --><ref name="who 1998"/><!--
| |
| --><ref name="trussell 2007"/><!--
| |
| --><ref name="trussell 2003a">{{cite journal |author=Trussell J, Ellertson C, von Hertzen H, Bigrigg A, Webb A, Evans M, Ferden S, Leadbetter C |year=2003 |title=Estimating the effectiveness of emergency contraceptive pills |journal=Contraception |volume=67 |issue=4 |pages=259-65 |id=PMID 12684144}}</ref><!--
| |
| --><ref name="ellerston 2003">{{cite journal |author=Ellertson C, Webb A, Blanchard K, Bigrigg A, Haskell S, Shochet T, Trussell J |year=2003 |title=Modifying the Yuzpe regimen of emergency contraception: a multicenter randomized controlled trial |journal=Obstet Gynecol |volume=101 |issue=6 |pages=1160-7 |id=PMID 12798518}}</ref>
| |
| * Combined data from two randomized trials that directly compared the two regimens, found the levonorgestrel regimen was twice as effective as the Yuzpe regimen.<!--
| |
| --><ref name="who 1998"/><!--
| |
| --><ref name="cheng 2004"/><!--
| |
| --><ref name="trussell 2007"/><!--
| |
| --><ref name="ho 1993">{{cite journal |author=Ho PC, Kwan MS |year=1993 |title=A prospective randomized comparison of levonorgestrel with the Yuzpe regimen in post-coital contraception |journal=Hum Reprod |volume=8 |issue=3 |pages=389-92 |id=PMID 8473453}}</ref><!--
| |
| --><ref name="raymond 2004">{{cite journal |author=Raymond E, Taylor D, Trussell J, Steiner MJ |year=2004 |title=Minimum effectiveness of the levonorgestrel regimen of emergency contraception |journal=Contraception |volume=69 |issue=1 |pages=79-81 |id=PMID 14720626}}</ref>
| |
|
| |
| Placebo-controlled trials that could give a precise measure of effectiveness for EC would be unethical, so the effectiveness percentage is estimated. This is currently done using variants of the calendar method.<!--
| |
| --><ref name="trussell 1996">{{cite journal |author=Trussell J, Ellertson C, Stewart F |year=1996 |title=The effectiveness of the Yuzpe regimen of emergency contraception |journal=Fam Plann Perspect |volume=28 |issue=2 |pages=58-64, 87 |id=PMID 8777940 |url=http://findarticles.com/p/articles/mi_qa3634/is_199603/ai_n8736107/print}}</ref>
| |
| Women with irregular cycles for any reason (including recent hormone use such as oral contraceptives and [[breastfeeding]]) must be excluded from such calculations. Even for women included in the calculation, the limitations of calendar methods of fertility determination have [[Rhythm Method#Reasons for high failure rate|long been recognized]].
| |
| Recently, hormonal assay has been suggested as a more accurate method of estimating fertility for EC studies.<!--
| |
| --><ref name="espinosa 1999">{{cite journal |author=Espinos JJ, Rodriguez-Espinosa J, Senosiain R, Aura M, Vanrell C, Gispert M, Vega C, Calaf J |year=1999 |title=The role of matching menstrual data with hormonal measurements in evaluating effectiveness of postcoital contraception |journal=Contraception |volume=60 |issue=4 |pages=243-7 |id=PMID 10640171}}</ref>
| |
|
| |
| ===Safety===
| |
| Existing pregnancy is not a [[contraindication]] in terms of safety, as there is no known harm to the woman, the course of her pregnancy, or the fetus if progestin-only or combined emergency contraception pills are accidentally used, but EC is not [[indication (medicine)|indicated]] for a woman with a known or suspected pregnancy because it is not effective in women who are already pregnant.<!--
| |
| --><ref name="trussell 2007"/><!--
| |
| --><ref name="aap">{{cite journal | author=[[American Academy of Pediatrics|AAP]] Committee on Adolescence | title=Emergency contraception | journal=Pediatrics | year=2005 | pages=1026-35 | volume=116 | issue=4|id=PMID 16147972 |url=http://www.aap.org/pressroom/ECstatement.pdf |format=PDF}}</ref><!--
| |
| --><ref name="grimes">
| |
| {{cite journal |author=Grimes DA, Raymond EG |year=2002 |title=Emergency contraception |journal=Ann Intern Med |volume=137 |issue=3 |pages=180-9 |id=PMID 12160366 |url=http://www.annals.org/cgi/reprint/137/3/180.pdf}}</ref><!--
| |
| --><ref name="acog">{{cite journal |author=[[American College of Obstetricians and Gynecologists|ACOG]] |year=2005 |title=ACOG Practice Bulletin, Number 69: Emergency contraception |journal=Obstet Gynecol |volume=106 |issue=6 |pages=1443-52 |id=PMID 16319278}}</ref><!--
| |
| --><ref name="fda med review">{{cite web |author=[[FDA]] |month=August 22, |year=2006 |title=Plan B Rx to OTC switch Medical Reviews |url=http://www.fda.gov/cder/foi/nda/2006/021045s011_Plan_B__MedR.pdf |format=PDF |accessdate=2006-12-13 |pages=pp. 32-7, 133-77}}</ref><!--
| |
| --><ref name="who mec">{{cite book |author=[[World Health Organization|WHO]] |year=2004 |title=Medical eligibility criteria for contraceptive use |edition=3rd ed. |chapter=Emergency contraceptive pills |location=Geneva |publisher=Reproductive Health and Research, WHO |id=ISBN 92-4-156266-8 |url=http://www.who.int/reproductive-health/publications/mec/6_ecps_july.pdf |format=PDF |accessdate=2006-12-13}}</ref><!--
| |
| --><ref name="ffprhc mec">{{cite web |author=[[Royal College of Obstetricians and Gynaecologists|FFRPHC]] |month=September 9, |year=2006 |title=The UK Medical Eligibility Criteria for Contraceptive Use (2005/2006) |url=http://www.ffprhc.org.uk/admin/uploads/UKMEC200506.pdf |format=PDF |accessdate=2006-12-13}}</ref><!--
| |
| --><ref name="doubt">{{cite journal |author=Davidoff F, Trussell J |year=2006 |title=Plan B and the politics of doubt |journal=[[Journal of the American Medical Association|JAMA]] |volume=296 |issue=14 |pages=1775-8 |id=PMID 17032991}}</ref>
| |
|
| |
| The [[World Health Organization|WHO]] ''Medical Eligibility Criteria for Contraceptive Use'' list no medical condition for which the risks of emergency contraceptive pills (using progestin-only or combined oral contraceptive pills) outweigh the benefits, specifically noting [[breastfeeding]] and history of [[ectopic pregnancy]] as conditions where there are no restrictions on use of ECPs, and history of severe [[cardiovascular disease]] ([[myocardial infarction|heart attack]], [[stroke]], [[thrombus|blood clots]]), [[Angina pectoris|angina]], [[migraine]], and severe [[liver disease]] (including [[jaundice]]) as conditions where the advantages of using emergency contraceptive pills generally outweigh the theoretical or proven risks.<ref name="who mec"/> The [[American Academy of Pediatrics]] (AAP) and experts on emergency contraception say progestin-only ECPs may be preferable to combined ECPs containing estrogen in women with a history of blood clots, stroke, or migraine.<!--
| |
| --><ref name="trussell 2007"/><!--
| |
| --><ref name="aap"/><!--
| |
| --><ref name="grimes"/>
| |
|
| |
| The AAP, [[American College of Obstetricians and Gynecologists]] (ACOG), U.S. [[Food and Drug Administration]], the WHO, the [[Royal College of Obstetricians and Gynaecologists]]'s Faculty of Family Planning & Reproductive Health Care (FFPRHC) and other experts on emergency contraception state that there are no medical conditions in which progestin-only ECPs are contraindicated.<!--
| |
| --><ref name="trussell 2007"/><!--
| |
| --><ref name="aap"/><!--
| |
| --><ref name="grimes"/><!--
| |
| --><ref name="acog"/><!--
| |
| --><ref name="fda med review"/><!--
| |
| --><ref name="who mec"/><!--
| |
| --><ref name="ffprhc mec"/>
| |
| The FFPRHC ''UK Medical Eligibility Criteria for Contraceptive Use'' specifically note current [[venous thrombosis|venous thromboembolism]], current or past history of [[breast cancer]], [[inflammatory bowel disease]], and [[acute intermittent porphyria]] as conditions where the advantages of using emergency contraceptive pills generally outweigh the theoretical or proven risks.<!--
| |
| --><ref name="ffprhc mec"/>
| |
|
| |
| The herbal preparation of [[St John's wort]] and some [[enzyme induction|enzyme-inducing]] drugs (e.g. [[anticonvulsant]]s or [[rifampicin]]) may reduce the effectiveness of ECP, and a larger dose may be required.<!--
| |
| --><ref name="ffprhc ec">{{cite journal |author=[[Royal College of Obstetricians and Gynaecologists|FFRPHC]] |year=2006 |title=FFPRHC Guidance (April 2006). Emergency contraception |journal=J Fam Plann Reprod Health Care |volume=32 |issue=2 |pages=121-8 |id=PMID 16824309 |url=http://www.ffprhc.org.uk/admin/uploads/449_EmergencyContraceptionCEUguidance.pdf |format=PDF}}</ref><!--
| |
| --><ref name="bnf,ffprhc">{{cite book |author=Joint Formulary Committee |month=Sep |year=2006 |title=British National Formulary |edition=52 |location=London |publisher=[[British Medical Association]]; Pharmaceutical Society of Great Britain |id=ISBN 0-85369-669-1}}<br/>
| |
| {{cite journal |author=[[Royal College of Obstetricians and Gynaecologists|FFRPHC]] |year=2006 |title=FFPRHC Guidance (April 2005). Drug interactions with hormonal contraception |journal=J Fam Plann Reprod Health Care |volume=31 |issue=2 |pages=139-51 |id=PMID 15921558 |url=http://www.ffprhc.org.uk/admin/uploads/DrugInteractionsFinal.pdf |format=PDF}}<br/>
| |
| {{cite journal |author=[[Royal College of Obstetricians and Gynaecologists|FFRPHC]] |year=2006 |title=FFPRHC Guidance (July 2005). The use of contraception outside the terms of the product licence |journal=J Fam Plann Reprod Health Care |volume=31 |issue=3 |pages=225-41 |id=PMID 16105289 |url=http://www.ffprhc.org.uk/admin/uploads/518_ContraceptionProductLicence.pdf |format=PDF}}</ref>
| |
|
| |
| The AAP, ACOG, FDA, WHO, FFPRHC and experts on emergency contraception say that ECPs, like all other contraceptives, reduce the absolute risk of ectopic pregnancy by preventing pregnancies, and that the best available evidence, obtained from over 7,800 women in [[randomized controlled trial]]s, indicates there is no increase in the relative risk of ectopic pregnancy in women who become pregnant after using progestin-only ECPs.<!--
| |
| --><ref name="trussell 2007"/><!--
| |
| --><ref name="aap"/><!--
| |
| --><ref name="grimes"/><!--
| |
| --><ref name="acog"/><!--
| |
| --><ref name="fda med review"/><!--
| |
| --><ref name="who mec"/><!--
| |
| --><ref name="ffprhc mec"/><!--
| |
| --><ref name="doubt"/><!--
| |
| --><ref name="ffprhc ec"/><!--
| |
| --><ref name="trussell 2003b">{{cite journal |author=Trussell J, Hedley A, Raymond E |year=2003 |title=Ectopic pregnancy following use of progestin-only ECPs |journal=J Fam Plann Reprod Health Care |volume=29 |issue=4 |pages=249 |id=PMID 14662065}}</ref>
| |
|
| |
| ===Side effects===
| |
| The most common side effect of emergency contraceptive pills is [[nausea]] (50% of users of combined pills, 23% of progestin-only users), and a significant number of users [[vomit]]. Estrogen in combined ECPs is responsible for the increased incidence of nausea and vomiting. [[Antiemetic]]s may be prescribed for both methods, to be taken 1 hour before each ECP dose. If vomiting occurs within an hour after taking ECP's, it may be necessary to repeat the dose.
| |
|
| |
| Other common side effects are [[abdominal pain]], [[fatigue (physical)|fatigue]], [[headache]], [[dizziness]], and [[mastalgia|breast tenderness]]. These side effects normally resolve within 24 hours.
| |
|
| |
| Temporary disruption of the menstrual cycle is also commonly experienced. If taken before ovulation, the high doses of progestogen in levonorgestrel treatments may induce [[Progestogen#Progestogen withdrawal bleeding|progestogen withdrawal bleeding]] a few days after the pills are taken. One study found that about half of women who used levonorgestrel ECPs experienced bleeding within 7 days of taking the pills.<!--
| |
| --><ref name="bleeding patterns">{{cite journal |author=Raymond E, Goldberg A, Trussell J, Hays M, Roach E, Taylor D |title=Bleeding patterns after use of levonorgestrel emergency contraceptive pills |journal=Contraception |volume=73 |issue=4 |pages=376-81 |year=2006 |pmid=16531171}}</ref> If levonorgestrel is taken after ovulation, it may increase the length of the [[luteal phase]], thus delaying menstruation by a few days.<!--
| |
| --><ref>{{cite journal |author=Gainer E, Kenfack B, Mboudou E, Doh A, Bouyer J |title=Menstrual bleeding patterns following levonorgestrel emergency contraception |journal=Contraception |volume=74 |issue=2 |pages=118-24 |year=2006 |pmid=16860049}}</ref> Mifepristone, if taken before ovulation, may delay ovulation by 3-4 days.<!--
| |
| --><ref>{{cite journal |author=Gemzell-Danielsson K, Marions L |title=Mechanisms of action of mifepristone and levonorgestrel when used for emergency contraception |journal=Hum Reprod Update |volume=10 |issue=4 |pages=341-8 |year=2004 |pmid=15192056}}</ref> (Delayed ovulation may result in a delayed menstruation.) These disruptions only occur in the cycle in which ECPs were taken; subsequent cycle length is not significantly affected.<ref name="bleeding patterns" /> If a woman's menstrual period is delayed by a week or more, it is advised that she take a [[pregnancy test]].<!--
| |
| --><ref>{{cite journal |author= |title=ACOG Practice Bulletin. Clinical Management Guidelines for Obstetrician-Gynecologists, Number 69, December 2005. Emergency contraception |journal=Obstet Gynecol |volume=106 |issue=6 |pages=1443-52 |year=2005 |pmid=16319278}}</ref> (Earlier testing may not give accurate results.)
| |
|
| |
| ==Intrauterine device (IUD) for emergency contraception==
| |
| An alternative to emergency contraceptive pills is the copper-T [[intrauterine device]] (IUD) which can be used up to 5 days after unprotected intercourse to prevent pregnancy. Insertion of an IUD is more effective than use of Emergency Contraceptive Pills - pregnancy rates when used as emergency contraception are the same as with normal IUD use. IUDs may be left in place following the subsequent menstruation to provide ongoing contraception (3-10 years depending upon type).<ref>{{cite journal | author = Gottardi G, Spreafico A, de Orchi L | title = The postcoital IUD as an effective continuing contraceptive method. | journal = Contraception | volume = 34 | issue = 6 | pages = 549-58 | year = 1986 | id = PMID 3549140}}</ref>
| |
|
| |
| ==Postcoital high-dose progestin-only oral contraceptive pills as ongoing contraception==
| |
| One brand of levonorgestrel pills, Postinor, is marketed as an ongoing method of postcoital contraception.<!--
| |
| --><ref name="beyond coca-cola">{{cite journal | last = Ellertson | first = Charlotte | title = History and Efficacy of Emergency Contraception: Beyond Coca-Cola | journal = Family Planning Perspectives | volume = 28 | issue = 2 | publisher = Guttmacher Institute | date = March/April 1996 | url = http://www.guttmacher.org/pubs/journals/2804496.html | accessdate = 2006-11-22 }}</ref> However, there are serious drawbacks to such use of postcoital high-dose progestin-only oral contraceptive pills, especially if they are not used according to their package directions, but are instead used according to the package directions of emergency contraceptive pills:
| |
| * Due to the increasing severity of side effects with frequent use, Postinor is only recommended for women who have intercourse four or fewer times per month.<ref name="beyond coca-cola" /><!--
| |
| --><ref>{{cite journal | author = Chernev T, Ivanov S, Dikov I, Stamenkova R | title = Prospective study of contraception with levonorgestrel. | journal = Plan Parent Eur | volume = 24 | issue = 2 | pages = 25 | year = 1995 | id = PMID 12290800}}</ref>
| |
| * If not used according to their package directions, but instead used according to the directions of levonorgestrel emergency contraceptive pills (up to 72 hours after intercourse), they would be estimated to have a "perfect-use" (when not used according to their package directions but used as directed on the package directions for levonorgestrel emergency contraception pills) pregnancy rate of 20% per year when used as the sole means of contraception (as compared to a 40% annual pregnancy rate for the Yuzpe regimen).<!--
| |
| --><ref name="princeton">{{cite web | title = Effectiveness of Emergency Contraceptives | work = The Emergency Contraception Website | publisher = [[Office of Population Research]] at [[Princeton University]] and the Association of Reproductive Health Professionals | date = November 2006 | url = http://ec.princeton.edu/questions/eceffect.html|accessdate = 2006-12-2 }}</ref> These failure rates would be higher than those of almost all other birth control methods, including the [[rhythm method]] and [[coitus interruptus|withdrawal]].<ref name="pkjfm">{{cite journal | last = Bakhtiar | first = Saadia | coauthors = Mehboob Ashraf | title = Contraception | journal = Pakistan Journal of Family Medicine | volume = 11 | pages = 19-24 | date = May 2000 | url = http://www.pakjfm.com/archives/may2000/index.htm | accessdate = 2006-12-2 }}</ref>
| |
| * Like all hormonal methods, postcoital high-dose progestin-only oral contraceptive pills do not protect against [[sexually transmitted infection]]s.<ref name="princeton2">{{cite web | title = What is Emergency Contraception? | work = The Emergency Contraception Website|publisher = Office of Population Research at [[Princeton University]] and the Association of Reproductive Health Professionals | date = November 2006 | url = http://ec.princeton.edu/emergency-contraception.html | accessdate = 2006-12-2 }}</ref>
| |
|
| |
| ECPs are generally recommended for backup or "emergency" use, rather than as the primary means of contraception. They are intended for use when other means of contraception have failed—for example, if a woman has forgotten to take a birth control pill or when a [[condom]] is torn during sex.<ref name="princeton" />
| |
|
| |
| ==History==
| |
| Interest in synthetic hormones as postcoital contraceptives originated several decades ago, with the first published study on the subject appearing in 1967.<!--
| |
| --><ref>{{cite journal | author = | title = Postcoital contraception. | journal = IPPF Med Bull | volume = 1 | issue = 4 | pages = 3 | year = 1967 | id = PMID 12254703}}</ref> A few different drugs were studied, with a focus on high-dose estrogens, and it was originally hoped that postcoital contraception would prove viable as an [[#ECPs as ongoing contraception|ongoing contraceptive method]].<!--
| |
| --><ref>{{cite journal | author = Demers L | title = The morning-after pill. | journal = N Engl J Med | volume = 284 | issue = 18 | pages = 1034-6 | year = 1971 | id = PMID 5553470}}</ref>
| |
|
| |
| The first widely used methods were five-day treatments with high-dose estrogens, using diethylstilbestrol (DES) in the US and ethinyl estradiol in the Netherlands.<!--
| |
| --><ref>{{cite journal | author = | title = FDA considers DES safe as 'morning-after' pill. | journal = JAMA | volume = 224 | issue = 12 | pages = 1581-2 | year = 1973 | id = PMID 12257949}}</ref><ref>{{cite journal|author=Johnson JH|title=Contraception-the morning after|journal=Fam Plann Perspect|year=1984|volume=16|issue=6|page=266-70|id=PMID 6519238}}</ref>
| |
|
| |
| In the early 1970s, the Yuzpe regimen was developed by AA Yuzpe (1974);<!--
| |
| --><ref>{{cite journal | author = Yuzpe A, Thurlow H, Ramzy I, Leyshon J | title = Post coital contraception--A pilot study. | journal = J Reprod Med | volume = 13 | issue = 2 | pages = 53-8 | year = 1974 | id = PMID 4844513}}</ref> progestin-only postcoital contraception was investigated (1975);<!--
| |
| --><ref>{{cite journal | author = Valle G | title = The problem of postcoital contraception using oral progestins | journal = Aggiorn Ostet Ginecol | volume = 8 | issue = 3 | pages = 127-8 | year = 1975 | id = PMID 12334868}}</ref> and the copper IUD was first studied for use as emergency contraception (1975).<!--
| |
| --><ref>{{cite journal | author = | title = Copper IUD, inserted after coitus averts pregnancy and provides continuing contraceptive protection. | journal = Int Fam Plann Dig | volume = 1 | issue = 3 | pages = 11-2 | year = 1975 | id = PMID 12307393}}</ref> [[Danazol]] was tested in the early 1980s in the hopes that it would have fewer side effects than Yuzpe, but was found to be ineffective.<ref>{{cite web|title=Danazol|publisher=Medscape|date=2002|accessdate=2006-11-08|url=http://www.medscape.com/viewarticle/423473_8}}</ref>
| |
|
| |
| The Yuzpe regimen became the standard course of treatment for postcoital contraception in many countries in the 1980s. The first prescription-only combined estrogen-progestin dedicated product, Schering PC4 (ethinylestradiol and norgestrel), was approved in the UK in January 1984 and first marketed in October 1984.<ref>{{cite web|title=Contraception: past, present and future|publisher=UK Family Planning Association|date=April, 2006|accessdate=2006-11-09|url=http://www.fpa.org.uk/about/info/contraceptionpastpresentandfuture.htm}}</ref> Schering introduced a second prescription-only combined product, Tetragynon (ethinylestradiol and levonorgestrel) in Germany in 1985.[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=3774816] By 1997, [[Schering AG]] dedicated prescription-only combined products had been approved in only 9 countries: the UK (Schering PC4), New Zealand (Schering PC4), South Africa (E-Gen-C), Germany (Tetragynon), Switzerland (Tetragynon), Denmark (Tetragynon), Norway (Tetragynon), Sweden (Tetragynon) and Finland (Neoprimavlar); and had been withdrawn from marketing in New Zealand in 1997 to prevent it being sold over-the-counter.[http://www.fda.gov/cder/foi/nda/99/21-045_Plan%20B_medr.pdf][http://www.amwa-doc.org/index.cfm?objectid=1413E9D2-D567-0B25-593F3D9007E7AA63][http://ec.princeton.edu/questions/dedicated.html] Regular combined oral contraceptive pills (which were less expensive and more widely available) were more commonly used for the Yuzpe regimen even in countries where dedicated products were available.<ref>{{cite journal |author=FDA |month=February 25, |year=1997 |title=Certain combined oral contraceptives for use as postcoital emergency contraception |journal=Fed Regist |volume=62 |issue=37 |pages=8610}} "Since the United Kingdom approved emergency contraceptive pills in 1984, more than 4 million prescriptions have been recorded. However, the actual use is much greater because providers have found it less expensive to provide tablets of identical drugs taken from products packaged as combined oral contraceptives."</ref>
| |
|
| |
| Over time, interest in progestin-only treatments increased. The Special Program on Human Reproduction (HRP), an international organization whose members include the [[World Bank]] and [[World Health Organization]], "played a pioneering role in emergency contraception" by "confirming the effectiveness of levonorgestrel."<ref>{{cite web|title=Sponsors|publisher=Fertility|date=2002|accessdate=2006-12-1|url=http://www.nature.com/fertility/sponsors/index.html}}</ref> After the WHO conducted a large trial comparing Yuzpe and levonorgestrel in 1998,<ref>{{cite journal|author=Task Force on Postovulatory Methods of Fertility Regulation|title=Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraception for emergency contraception|journal=Lancet|year=1998|volume=352|issue=9126|page=428-33|id=PMID 9708750}}</ref><ref>{{cite journal|author=Guillebaud J|title=Time for emergency contraception with levonorgestrel alone|journal=Lancet|year=1998|volume=352|issue=9126|page=416-7|id=PMID 9708743}}</ref> combined estrogen-progestin products were gradually withdrawn from some markets (''Preven'' in the [[United States]] discontinued May 2004, ''Schering PC4'' in the UK discontinued October 2001, and ''Tetragynon'' in France) in favor of progestin-only EC, although prescription-only dedicated Yuzpe regimen products are still available in some countries.
| |
|
| |
| In 2002, China became the first country in which mifepristone was registered for use as EC.
| |
|
| |
| ===United States===
| |
| * '''[[diethylstilbestrol|DES]]'''
| |
| ** In 1971, a ''[[New England Journal of Medicine]]'' editorial calling attention to previously published studies on the use of 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>{{cite journal |author=Demers LM |year=1971 |title=The morning-after pill |journal=N Engl J Med |volume=284 |issue=18 |pages=1034-6 |id=PMID 5553470}}</ref><ref>{{cite journal |author=Kuchera LK |year=1971 |title=Postcoital contraception with diethylstilbestrol |journal=JAMA |volume=218 |issue=4 |pages=562-3 |id=PMID 5171004}}</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 |author=FDA |year=1973 |month=May |title=Postcoital diethylstilbestrol |url=http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1455105&blobtype=pdf |format=PDF |journal=FDA Drug Bull}}</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 mg tablets (which were being used off-label as postcoital contraceptives).<ref name=proposed73>{{cite journal |author=FDA |month=September 26, |year=1973 |title=Diethylstilbestrol. Use as postcoital contraceptive; patient labeling |journal=Fed Regist |volume=38 |issue=186 |pages=26809-11}}</ref><ref>{{cite journal |author=FDA |month=February 26, |year=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="des25mg1973">{{cite journal |author=FDA |month=September 26, |year=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><ref>{{cite journal |author=FDA |month=February 26, |year=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>
| |
| ** In late 1973, [[Eli Lilly and Company|Eli Lilly]], the largest U.S. manufacturer of DES, discontinued its DES 25 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 |id=ISBN 0-521-34023-3}}</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 |month=February 5, |year=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 mg (and higher) tablets removed from the market and ordered the labeling of lower doses (5 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="des25mg1975">{{cite journal |author=FDA |month=February 5, |year=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><ref name="deslabel1975">{{cite journal |author=FDA |month=February 26, |year=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>
| |
| ** 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 |year=1978 |month=March/April |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 |author=Hatcher, Robert A.; Stewart, Gary K., Stewart, Felicia; Guest, Felicia; Schwartz, David W.; Jones, Stephanie A. |year=1980 |title=Contraceptive Technology 1980-1981 |edition=10th ed. |location=New York |publisher=Irvington Publishers |id=ISBN 0-8290-0084-4 |pages=pp. 128-33}}</ref><ref>{{cite book |author=Hatcher, Robert A.; Stewart, Gary K., Stewart, Felicia; Guest, Felicia; Josephs, Nancy; Dale, Janet |year=1982 |title=Contraceptive Technology 1982-1983 |edition=11th ed.|location=New York |publisher=Irvington Publishers |id=ISBN 0-8290-0705-9 |pages=pp. 152-7}}</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|author=Ibarreta, Dolores; Swain, Shanna H. |year=2001 |chapter=The DES story: long-term consequences of prenatal use |editor=in Harremoës, Poul; Gee, David; Vaz, Sofia Guedes (eds.) |title=Late lessons from early warnings: the precautionary principle 1896-2000 |location=Copenhagen |publisher=European Environmental Agency |id=ISBN 92-9167-323-4 |pages=pp. 84-92 |url=http://reports.eea.europa.eu/environmental_issue_report_2001_22/en/issue-22-part-08.pdf |format=PDF |accessdate=2006-12-07}}</ref>
| |
|
| |
| * '''Yuzpe regimen & Preven'''
| |
| ** On February 25, 1997, the FDA posted a notice in the ''[[Federal Register]]'' saying it had concluded that the Yuzpe regimen was safe and effective for off-label use as postcoital EC, was prepared to accept NDAs for COCPs labeled as ECPs, and listed 6 then available COCPs (there are now 22) that could be used as ECPs.<ref name="ecp US brands"><ref>{{cite journal |author=FDA |month=February 25, |year=1997 |title=Certain combined oral contraceptives for use as postcoital emergency contraception |journal=Fed Regist |volume=62 |issue=37 |pages=8610-2}}</ref>
| |
| ** On September 1, 1998, the FDA approved the prescription Yuzpe regimen Preven Emergency Contraception Kit (which contained a urine pregnancy test and 4 COCPs).<ref>{{cite web |author=FDA |month=September 1, |year=1998 |title=Preven approval package |url=http://www.fda.gov/cder/foi/nda/98/20946.pdf |format=PDF |accessdate=2006-12-10}}</ref> Preven was discontinued in May 2004.<ref>{{cite web |author=California Board of Pharmacy |year=2004 |month=December 22, |title=Pharmacists protocol for dispensing emergency contraception |url=http://www.pharmacy.ca.gov/licensing/ec_protocol.pdf |format=PDF |accessdate=2006-12-10}}</ref>
| |
|
| |
| * '''Plan B'''
| |
| ** On July 28, 1999, the FDA approved the prescription progestin-only Plan B (two 750 µg levonorgestrel pills) emergency contraceptive.<ref>{{cite web |author=FDA |month=July 28, |year=1999 |title=Plan B approval package |url=http://www.fda.gov/cder/foi/nda/99/21-045_PlanB.htm |accessdate=2006-12-10}}</ref>
| |
| ** On August 24, 2006, the FDA approved nonprescription behind-the-counter access to Plan B from pharmacies staffed by a licensed pharmacist for women 18 or older; a prescription-only form of Plan B will remain available for young women aged 17 and younger.<ref>{{cite web |author=FDA |month=August 24, |year=2006 |title=Plan B information page |url=http://www.fda.gov/cder/drug/infopage/planB/default.htm |accessdate=2006-12-10}}</ref>
| |
| ** On November 6, 2006, [[Barr Pharmaceuticals]] announced that its subsidiary, Duramed Pharaceutials, had initiated shipment of dual-label Plan B OTC/Rx and it would be available in pharmacies across the U.S. by mid-November 2006.<ref>{{cite web |author=Barr Pharmaceuticals |month=November 6, |year=2006 |title=Barr Launches Plan B® OTC/Rx Dual-Label Product; Awarded 3 Years New Product Exclusivity |url=http://phx.corporate-ir.net/phoenix.zhtml?c=60908&p=irol-newsArticle&ID=926964 |accessdate=2006-12-12}}</ref>
| |
|
| |
| ===International Consortium for Emergency Contraception===
| |
| In 1995, the [[Rockefeller Foundation]] convened a meeting to discuss emergency contraception. After the meeting, a group of seven international organizations formed The International Consortium for Emergency Contraception (ICEC) to promote EC as a part of mainstream reproductive health care worldwide.<ref name="icechistory">[http://www.cecinfo.org/about/history.htm International Consortium for Emergency Contraception (ICEC) webpage], section on "History". Accessed 30 November 2006.</ref> Dedicated products for EC were "virtually unknown" in 1995, there was little awareness of EC as an option, and EC was not used as public health measure.<ref name="icecproducts">[http://www.cecinfo.org/issues/productsAccess.htm ICEC web page], section on "Products and Availability". Accessed 30 November 2006.</ref>
| |
|
| |
| The seven founding member organizations were the [[Concept Foundation]], the [[International Planned Parenthood Federation]] (IPPF), the Pacific Institute for Women's Health, the [[World Health Organization]] (WHO), the [[Population Council]], [[Population Services International]], and the Program for Appropriate Technology in Health (PATH).<ref name="icechistory"/>
| |
|
| |
| The Concept Foundation is the distribution arm of ICEC; its funding for the development of Postinor-2 came from the Rockefeller Foundation and the [[David and Lucile Packard Foundation]], as well as the other ICEC organizations.<ref>{{cite web|title=Concept Foundation|publisher=Initative on Public-Private Partnerships for Health|date=March 7, 2006|accessdate=2006-11-17|url=http://www.ippph.org/index.cfm?page=/ippph/partnerships/name&thechoice=show&id=5&typobj=0}} Funding data requires free registration to view.</ref>
| |
|
| |
| The Consortium helped promote the availability of EC by:<ref name="icecproducts"/>
| |
| *Manufacturing an EC product. The ICEC worked with the Hungarian pharmaceutical firm Gedeon Richter to repackage its contraceptive Postinor as an emergency contraceptive, called Postinor-2. Distributing Postinor-2, principally in developing countries, was the primary work of the ICEC.
| |
| *Facilitating product registration in two ways. First, the ICEC encouraged interest in EC products through meetings with public-sector agencies and [[non-governmental organizations]] (NGOs) who they perceived would benefit from adding EC to the products they distribute. Second, by helping organizations applying for EC registration through the country-specific approval process, including lobbying of local leaders who may be influential in the registration decision.
| |
| *Negtiotiating a public-sector price. The ICEC's agreement with Gedeon Richter provided a discount price at which EC could be obtained by public-sector agencies in developing countries.
| |
| *Marketing and [[social marketing]].
| |
|
| |
| An ICEC member organization, the International Planned Parenthood Federation (IPPF), has launched its own dedicated levonorgestrel EC product, Optinor.<ref>{{cite web|title=IPPF Launches New EC Pill at ICEC Meeting|publisher=Consortium News|date=October, 2006|accessdate=2006-11-17|url=http://www.cecinfo.org/about/news.php}}</ref>
| |
|
| |
|
| ==Relationship to risky sex and abortion== | | ==[[Emergency contraception overview|Overview]]== |
|
| |
|
| The current (October 2005) ''[[American Academy of Pediatrics| AAP]] Policy Statement on Emergency Contraception'' states: "The concern that widespread emergency contraception use would encourage unprotected coitus in teens is not supported in the literature."<!--
| | ==[[Emergency contraception historical perspective|Historical Perspective]]== |
| --><ref name="aap"/>
| |
|
| |
|
| The current (December 2005) ''[[American College of Obstetricians and Gynecologists| ACOG]] Practice Bulletin on Emergency Contraception'' states: "A prominent concern among both women and health care providers is that making emergency contraception more readily available could encourage irresponsible sexual behavior, which would increase the risks of both unintended pregnancy and sexually transmitted diseases. However, numerous studies have shown that this concern is unfounded."<!--
| | ==[[Emergency contraception classification|Classification]]== |
| --><ref name="acog"/>
| |
|
| |
|
| The latest (April 2007) review by emergency contraception experts Trussell and Raymond<!--
| | ==[[Emergency contraception mechanism of action|Mechanism of Action]]== |
| --><ref name="trussell 2007"/> states: "Reported evidence demonstrates that making ECPs more widely available does not increase risk-taking<!--
| |
| --><ref>{{cite journal |author=Glasier A, Baird D |year=1998 |title=The effects of self-administering emergency contraception |journal=N Engl J Med |volume=339 |issue=1 |pages=1-4 |id=PMID 9647872}}</ref><!--
| |
| --><ref>{{cite journal |author=Raine T, Harper C, Leon K, Darney P |year=2000 |title=Emergency contraception: advance provision in a young, high-risk clinic population |journal=Obstet Gynecol |volume=96 |issue=1 |pages=1-7 |id=PMID 10862832}}</ref><!--
| |
| --><ref>{{cite journal |author=Jackson RA, Schwarz EB, Freedman L, Darney P |year=2003 |title=Advance supply of emergency contraception: effect on use and usual contraception―a randomized trial |journal=Obstet Gynecol |volume=102 |issue=1 |pages=8-16 |id=PMID 12850599}}</ref><!--
| |
| --><ref>{{cite journal |author=Gold MA, Wolford JE, Smith KA, Parker AM |year=2004 |title=The effects of advance provision of emergency contraception on adolescent women’s sexual and contraceptive behaviors |journal=J Pediatr Adolesc Gynecol |volume=17 |issue=2 |pages=87-96 |id=PMID 15050984}}</ref><!--
| |
| --><ref>{{cite journal |author=Lo SS, Fan SYS, Ho PC, Glasier AF |year=2004 |title=Effect of advanced provision of emergency contraception on women’s contraceptive behavior: a randomized controlled trial |journal=Hum Reprod |volume=19 |issue=10 |pages=2404-10 |id=PMID 15333602}}</ref><!--
| |
| --><ref>{{cite journal |author=Raine TR, Harper CC, Rocca CH, Fischer R, Padian N, Klausner JD, Darney PD |year=2005 |title=Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: a randomized controlled trial |journal=JAMA |volume=293 |issue=1 |pages=54-62 |id=PMID: 15632336 }}</ref><!--
| |
| --><ref>{{cite journal |author=Hu X, Cheng L, Hua X, Glasier A |year=2005 |title=Advanced provision of emergency contraception to postnatal women in China makes no difference in abortion rates: a randomized controlled trial |journal=Contraception |volume=72 |issue=2 |pages=111-6 |id=PMID 16022849}}</ref><!--
| |
| --><ref>{{cite journal |author=Belzer M, Sanchez K, Olson J, Jacobs AM, Tucker D |year=2005 |title=Advance supply of emergency contraception: a randomized trial in adolescent mothers |journal=J Pediatr Adolesc Gynecol. |volume=18 |issue=5 |pages=347-54 |id=PMID 16202939}}</ref><!--
| |
| --><ref>{{cite journal |author=Trussell J, Raymond E, Stewart FH |year=2006 |title=Advance supply of emergency contraception: a randomized trial in adolescent mothers (Letter to the editor) |journal=J Pediatr Adolesc Gynecol |volume=19 |issue=3 |pages=251 |id=PMID 16731424}}</ref><!--
| |
| --><ref>{{cite journal |author=Walsh TL, Frezieres RG |year=2006 |title=Patterns of emergency contraception use by age and ethnicity from a randomized trial comparing advance provision and information only |journal=Contraception |volume=74 |issue=2 |pages=110-7 |id=PMID 16860048}}</ref><!--
| |
| --><ref>{{cite journal |author=Raymond EG, Stewart F, Weaver M, Monteith C, Van Der Pol B |year=2006 |title=Impact of increased access to emergency contraceptive pills: a randomized controlled trial |journal=Obstet Gynecol |volume=108 |issue=5 |pages=1098-106 |id=PMID 17077230}}</ref>
| |
| and that women who are the most diligent about ongoing contraceptive use are those most likely to seek emergency treatment.<!--
| |
| -->"<ref>{{cite journal |author=Kosunen E, Sihvo S, Hemminki E |year=1997 |title=Knowledge and use of hormonal emergency contraception in Finland |journal=Contraception |volume=55 |issue=3 |pages=153-7 |id=PMID 9115003}}</ref>
| |
|
| |
|
| However, the availability of ECPs has not been shown to lower abortion rates. In France, Sweden, and Britain—where Yuzpe-regimen EC had been available by prescription for more than a decade and progestin-only EC has been available without a prescription for 8, 6, and 2 years respectively—the abortion rate was stable or higher during that time period.<ref>{{cite web|title=Emergency Contraception Doesn't Lower Abortion Rates|publisher=Forbes|year=September 15, 2006|accessdate=2006-09-23|url=http://www.forbes.com/forbeslife/health/feeds/hscout/2006/09/15/hscout534950.html}}</ref> Another study concluded that distribution of free, advance supplies of EC to large numbers of women in Scotland did not reduce abortion rates.<ref>{{cite journal|author=Glasier A, Fairhurst K, Wyke S, Zieblad S, Seaman P, Walker J, Lakha F|title=Advanced provision of emergency contraception does not reduce abortion rates|journal=Contraception|year=2004|volume=69|issue=5|page=36|id=PMID 15105057}}</ref> A [[randomized controlled trial]] of 2000 women in China compared women with advance access to EC to women without access, and noted that the pregnancy rate was the same between the two groups. The study observed that "...providing EC in advance increases use, but there is no direct evidence that it reduces unintended pregnancy" and concluded that EC may not lower abortion rates.<ref>{{cite journal|author=Hu X et al|title=Advanced provision of emergency contraception to postnatal women in China makes no difference in abortion rates: a randomized controlled trial|journal=Contraception|volume=72|issue=2|page=111-6|year=2005|id=PMID 16022849}}</ref>
| | ==[[Emergency contraception pathophysiology|Pathophysiology]]== |
|
| |
|
| In September 2006, emergency contraception expert Anna Glasier wrote a ''[[British Medical Journal| BMJ]]'' editorial entitled "Emergency Contraception. Is it worth all the fuss?" that said in closing: "So is emergency contraception worth the fuss? If you are a woman who has had unprotected sex then of course it is, because emergency contraception will prevent pregnancy in some women some of the time—and if you don’t want to get pregnant anything is better than nothing. If you are the ''[[Canadian Medical Association Journal|CMAJ]]’''s editor or FDA commissioner then yes, because scientific freedom is worth the fight. If you are looking for an intervention that will reduce abortion rates, emergency contraception may not be the solution, and perhaps you should concentrate most on encouraging people to use contraception before or during sex, not after it."<!--
| | ==[[Emergency contraception causes|Causes]]== |
| --><ref name="fuss">{{cite journal |author=Glasier, A |year=2006 |title=Emergency contracpetion: Is it worth all the fuss? |journal=BMJ |volume=333 |issue=7568 |pages=560-1 |id=PMID 16973989}}</ref>
| |
|
| |
|
| ==EC and sexual assault== | | ==[[Emergency contraception differential diagnosis|Differentiating Emergency contraception from other Diseases]]== |
|
| |
|
| Before EC was used in the general population or defined as "emergency contraception," it was used, beginning in the 1960s and 70s, specifically as a treatment for victims of sexual assault.<ref>{{cite web|author=Glover D eta al|title=Diethylstilbestrol in the treatment of rape victims|publisher=West J Med|date=1976|accessdate=2006-11-09|url=http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1237330}}</ref><ref>{{cite journal|author=Diamond EF|title=Physician notes hazards of DES use to prevent pregnancy|journal=Hosp Prog|year=1978|volume=59|issue=3|page=6-10|id=PMID 631811}}</ref> Although EC is in wide use as an option for victims of sexual assault, some researchers believe it is underutilized as a public health measure.<ref>{{cite journal | last = Stewart | first = Felicia H. | coauthors = James Trussell. | year = 2000 | month = November | title = Prevention of pregnancy resulting from rape: A neglected preventive health measure | journal = American Journal of Preventive Medicine | volume = 19 | issue = 4 | page = 228-229 | id = PMID 11064225| doi = 10.1016/S0749-3797(00)00243-9| url = http://www.ingentaconnect.com/content/els/07493797/2000/00000019/00000004/art00243;jsessionid=12ho4w9a3akpe.alice | accessdate = 2006-08-23}}</ref> Abortions because of rape account for less than one percent of all annual abortions.<ref>{{cite journal | last = Finer | first = Lawrence B. | coauthors = Lori F. Frohwirth, Lindsay A. Dauphinee, Susheela Singh, and Ann M. Moore | year = 2005 | month = September | title = Reasons U.S. Women Have Abortions: Quantitative and Qualitative Perspectives | journal = Perspectives on Sexual and Reproductive Health | volume = 37 | issue = 3 | pages = 110-118 | url = http://www.guttmacher.org/pubs/journals/3711005.pdf | id = PMID 16150658 | accessdate = 2006-08-23}}</ref>
| | ==[[Emergency contraception epidemiology and demographics|Epidemiology and Demographics]]== |
|
| |
|
| ==Mechanism of action== | | ==[[Emergency contraception risk factors|Risk Factors]]== |
| A number of studies in the 1970s and 80s concluded that emergency contraception could cause changes in the [[endometrium]]<ref>{{cite journal | author=Ling WY, Robichaud A, Zayid I, Wrixon W, MacLeod SC | title=Mode of action of dl-norgestrel and ethinylestradiol combination in postcoital contraception | journal=Fertil Steril | year=1983 | pages=631-6 | volume=40| issue=5 | id=PMID 6628707}}<br />{{cite journal | author=Kubba AA, White JO, Guillebaud J, Elder MG | title=The biochemistry of human endometrium after two regimens of postcoital contraception: a dl-norgestrel/ethinylestradiol combination or danazol | journal=Fertil Steril | year=1986 | pages=512-516 | volume=45 | issue=4 | id=PMID 3956767}}<br />{{cite journal | author=Yuzpe AA, Thurlow HJ, Ramzy I, Leyshon JI | title=Post coital contraception—a pilot study | journal=J Reprod Med | year=1974 | pages=53-8 | volume=13 | issue=2|id=PMID 4844513}}</ref> that would prevent implantation of an early-stage [[embryo]] in the [[uterus]]. This research led many [[pro-life]] advocates, who believe that [[beginning of pregnancy controversy|pregnancy begins at fertilization]], to oppose ECPs as an [[abortifacient]].
| |
|
| |
|
| In recent years--especially in light of U.S. ethical controversy over the research's claims--the scientific community has begun to critically reevaluate the early studies, introducing doubt into the argument that ECPs prevent implantation. Recent studies in rats and monkeys have shown that post-ovulatory use of progestin-only and combined ECPs have no effect on pregnancy rates.<ref name="mechanism article">{{cite journal | title = Emergency Contraception's Mode of Action Clarified | journal = Population Briefs | volume = 11 | issue = 2 | publisher = Population Council | date = May 2005 | url = http://www.popcouncil.org/publications/popbriefs/pb11(2)_3.html Article | accessdate = 2006-08-27 }}</ref><ref>{{cite journal | author = Ortiz ME, Ortiz RE, Fuentes MA, Parraguez VH, Croxatto HB | title = Post-coital administration of levonorgestrel does not interfere with post-fertilization events in the new-world monkey ''Cebus apella'' | journal = Human Reproduction | volume = 19 | issue = 6 | pages = 1352-1356 | publisher = European Society of Human Reproduction and Embryology | date = June 2004 | url = http://humrep.oxfordjournals.org/cgi/content/abstract/19/6/1352 | accessdate = 2007-04-11 }}</ref> Studies in humans have shown that the rate of ovulation suppression is approximately equal to the effectiveness of emergency contraceptive pills,<ref name="cycle day">{{cite journal | author=Durand M, del Carmen Cravioto M, Raymond EG, Duran-Sanchez O, De la Luz Cruz-Hinojosa M, Castell-Rodriguez A, Schiavon R, Larrea F | title=On the mechanisms of action of short-term levonorgestrel administration in emergency contraception | journal=Contraception | year=2001 | pages=227-34 | volume=64 | issue=4 | id=PMID 11747872}}</ref><ref>{{cite journal | author = Croxatto HB, Brache V, Pavez M, Cochon L, Forcelledo ML, Alvarez F, Massai R, Faundes A, Salvatierra AM | title = Pituitary-ovarian function following the standard levonorgestrel emergency contraceptive dose or a single 0.75-mg dose given on the days preceding ovulation | journal = Contraception | volume = 70 | issue = 6 | pages = 442-450 | date = December 2004 | id=PMID 15541405 }}</ref> suggesting that might be the only mechanism by which they prevent pregnancy.
| | ==[[Emergency contraception natural history, complications and prognosis|Natural History, Complications and Prognosis]]== |
|
| |
|
| However, these studies have also shown that, in women who ovulate despite taking ECP before ovulation, there are changes in certain hormones such as progesterone and in the length of [[luteal phase]].<ref name="cycle day" /> These secondary changes might inhibit implantation in cases where fertilization occurs despite ECP use. Because of the difficulty of studying embryos inside the uterus and fallopian tubes prior to implantation, both sides of this debate concede that completely proving or disproving the theory may be impossible.<ref>{{cite web | last = Bollinger | first = Caroline | title = The Post-Fertilization Effect: Fact or Fiction? | url = http://www.prevention.com/article/0,,s1-1-93-35-4166-1,00.html | publisher = Prevention.com | accessdate = 2006-08-26}}</ref><ref name="mechanism article" />
| | ==[[Emergency contraception cultural aspects|Cultural Aspects]]== |
| | ==Diagnosis== |
| | [[Emergency contraception history and symptoms|History and Symptoms]] | [[Emergency contraception physical examination|Physical Examination]] | [[Emergency contraception other imaging findings|Other Imaging Findings]] | [[Emergency contraception other diagnostic studies|Other Diagnostic Studies]] |
|
| |
|
| The Food and Drug Administration recently stopped its practice<ref>{{cite web | title = FDA's Decision Regarding Plan B: Questions and Answers | date = 2004-05-07 | publisher = Center for Drug Evaluation and Research | url = http://www.fda.gov/cder/drug/infopage/planB/planBQandA.htm| | accessdate = 2006-08-25}}</ref> of referring to all three mechanisms in its publications on emergency contraception.<ref>{{cite web | title = FDA's Decision Regarding Plan B: Questions and Answers: August 24, 2006 | date = 2006-08-24 | publisher = Center for Drug Evaluation and Research | url = http://www.fda.gov/cder/drug/infopage/planB/planBQandA20060824.htm| accessdate = 2006-08-25}}</ref> However, the approved box design for Plan B still carries a notification that it may prevent implantation.<ref>{{cite web | last = Galson | first = Stephen | title = Notification to Duramed Research, Inc. of FDA Approval of Plan B | date = 2006-08-24 | format = PDF | publisher = Center for Drug Evaluation and Research | url = http://www.fda.gov/cder/drug/infopage/planB/approval.pdf | accessdate = 2006-08-25}}</ref>
| | ==Treatment== |
| | [[Emergency contraception medical therapy|Medical Therapy]] | [[Emergency contraception surgery|Surgery]] | [[Emergency contraception primary prevention|Primary Prevention]] | [[Emergency contraception cost-effectiveness of therapy|Cost-Effectiveness of Therapy]] | [[Emergency contraception future or investigational therapies|Future or Investigational Therapies]] |
|
| |
|
| When used as a regular method of contraception, IUDs have been proven to act primarily through spermicidal and ovicidal mechanisms, but it is considered possible that these same mechanisms are also harmful to embryos that have not yet implanted.<ref>{{cite web | title = Mechanisms of the Contraceptive Action of Hormonal Methods and Intrauterine Devices (IUDs) | work = Family Health International | year = 2006 | url = http://www.fhi.org/en/RH/Pubs/booksReports/methodaction.htm | accessdate = 2006-07-05 }}<br />{{cite web | last = Keller | first = Sarah | title = IUDs Block Fertilization | work = Network | publisher = Family Health International | year = Winter 1996, Vol. 16, No. 2 | url = http://www.fhi.org/en}}</ref>
| | == Case Studies == |
| | [[Emergency contraception case study one|Case #1]] |
|
| |
|
| Hormonal progestin-only and combined estrogen-progestin emergency contraceptives such as [[Yuzpe regimen]] or Plan B are different from the anti-hormonal drug [[mifepristone]] (also known as Mifeprex and RU-486), an abortifacient which can induce abortion if taken after implantation. Yuzpe and progestin-only emergency contraception will have no effect if taken after implantation.
| | ==External Links== |
| | |
| ==United States legal and ethical controversies==
| |
| | |
| *A great deal of controversy accompanied the FDA approval of [[Over-the-counter drug|over-the-counter]] (OTC) access to Plan B. Supporters of over-the-counter access believe that easier access will reduce unintended pregnancy and abortion rates; some pro-life opponents believe that EC itself is a form of abortion.<ref>{{cite web|title=Q&A: The Debate over the Morning-After Pill|publisher=NPR|date=August 15, 2006|accessdate=2006-11-11|url=http://www.npr.org/templates/story/story.php?storyId=5651176}}</ref> The [[American Medical Association]], the [[American Academy of Family Physicians]], the [[American College of Obstetricians and Gynecologists]], the [[American Academy of Pediatrics]], and other leading U.S. medical organizations all supported OTC access.<ref>"[http://www.fda.gov/OHRMS/DOCKETS/ac/03/briefing/4015b1.htm Briefing Document (1.2.4 Plan B: Rx-to-OTC Switch)]". FDA.gov: December 16, 2003. Accessed August 2, 2006.</ref> An advisory committee to the FDA recommended that Plan B be made available over the counter in 2003.<ref>"[http://www.cnn.com/2003/HEALTH/12/16/morning.after.pill/index.html Panel backs over-the-counter 'morning-after' pill]". CNN.com: December 17, 2003. Accessed April 28, 2006.</ref> In 2004, the FDA refused the advisory board's recommendation and prohibited over-the-counter sale, citing insufficient evidence that ECPs could be used safely by adolescents without medical supervision. [[Reproductive rights]] supporters accused the FDA of basing the decision on political pressure from the pro-life lobby. The Center for Reproductive Rights filed a lawsuit regarding the approval process, which has not been resolved [[as of December 2006]]. In the legal proceedings, two senior FDA officials have alleged in [[deposition]]s that the decision to reject the OTC application was made on political, rather than scientific, grounds to "appease the [[George W. Bush Administration|administration's]] constituents".<ref name="reuters">[http://www.msnbc.msn.com/id/14175795/ "Plan B decision made before analysis finished"], from Reuters via MSNBC.com. Accessed 10 November 2006.</ref><ref>{{cite web|title=Depositions Indicate Bush Administration Exerted Political Influence on FDA During Plan B Review Process|publisher=Center for Reproductive Rights|date=August 3, 2006|accessdate=2006-11-10|url=http://www.reproductiverights.org/pr_06_0803FDADepositions.html}}</ref> Depositions taken from other FDA officials do not indicate White House involvement.<ref name="reuters"/> In 2006, the FDA approved over-the-counter access to Plan B for women 18 years of age and older.<ref>[http://www.fda.gov/bbs/topics/NEWS/2006/NEW01436.html Announcement on FDA's website]</ref>
| |
|
| |
| *A [[Massachusetts]] law that went into effect on 14 December, 2005, requires all [[hospital]]s in the state to provide emergency contraception to any "female rape victim of childbearing age"<ref>Commonwealth of Massachusetts Chapter 91 of the Acts of 2005. "[http://www.mass.gov/legis/laws/seslaw05/sl050091.htm An Act Providing Timely Access to Emergency Contraception.]" Enacted September 15, 2005. Accessed April 28, 2006.</ref> including Catholic Hospitals who oppose the provision of emergency contraception. In a letter criticizing the joint [[United Nations|UN]]/[[World Health Organization|WHO]] ''Inter-agency Field Manual on Reproductive Health in Refugee Situations'', the Catholic Church explains its belief that emergency contraception, along with IUDs and [[Progestagen|hormonal]] [[Birth control|contraception]], cannot be considered "solely contraceptive because in the case of effective fertilization a chemical abortion would be carried out during the first days of pregnancy."<ref>Barragán, Javier L., Hamao, Stephen F., and Trujillo, Alfonsocard L. [http://www.vatican.va/roman_curia/pontifical_councils/migrants/documents/rc_pc_migrants_doc_2003072_salud%20reproductiva_en.html The Reproductive Health of Refugees]. Pontifical Council for the Pastoral Care of Migrants and Itinerant People. September 14, 2001. Accessed April 28, 2006.</ref> The Catholic position on family planning is explained further in ''Ethical and Religious Directives for Catholic Health Care Services.''<ref>"[http://www.usccb.org/bishops/directives.shtml Ethical and Religious Directives for Catholic Health Care Services, Fourth Edition]." ''United States Conference of Catholic Bishops.'' 2001. Accessed April 28, 2006.</ref> Because of this expressed moral stance against emergency contraception, the Massachusetts Catholic Conference opposed this law, stating interference with [[Freedom of religion|religious freedom]]. According to ''[[The New England Journal of Medicine]]'', "compelling arguments can be made both for and against a pharmacist's right to refuse prescriptions for emergency contraception."<ref>{{cite web|aithor=Julie Cantor,J.D.,and Ken Baum,M.D.,J.D.|title=The Limits of Conscientious Objection - May Pharmacists Refuse to Fill Prescriptions for Emergency Contraception?|publisher=NEJM|date=November 4, 2004|accessdate=2006-11-13|url=http://www.yale.edu/opa/docs/campus/20041104_nejm.pdf}}</ref>
| |
| | |
| *In isolated instances across the United States, pharmacists have refused to dispense emergency contraception even when presented with a legal prescription.<ref>{{cite web | last = Friedman | first = Deborah | title = Refusal Clauses: A Threat to Reproductive Rights | work = Planned Parenthood Federation of America | date = 2004 | url=http://www.plannedparenthood.org/news-articles-press/politics-policy-issues/birth-control-access-prevention/refusal-clauses-6544.htm|accessdate = 2006-09-25 }}</ref> In addition, [[Wal-Mart]], the nation's fifth-largest distributor of pharmaceuticals, refused to stock EC, beginning with Preven in 1999.<ref>{{cite web|author=Dana Canedy|title=Wal-Mart Decides Against Selling a Contraceptive|publisher=New York Times|date=May 14, 1999|accessdate=2006-11-08|url=http://query.nytimes.com/gst/fullpage.html?res=9D0DE2D91E3FF937A25756C0A96F958260&sec=health&pagewanted=1}}</ref> However, Wal-Mart reversed this position when it was announced that stores would sell Plan B in March of 2006.<ref>{{cite web|author=Michael Barbaro|title=In Reversal, Wal-Mart Will Sell Contraceptive|publisher=New York Times|March 4, 2006|accessdate=2007-08-12|url=http://www.nytimes.com/2006/03/04/business/04walmart.html?ex=1187064000&en=1bbc5901c5cc5bda&ei=5070}}</ref>
| |
| | |
| ==Footnotes==
| |
| <div class="references-small">{{reflist|2}}</div>
| |
| | |
| ==External links== | |
| * [http://ec.princeton.edu The Emergency Contraception Website (not-2-late.com)] – by the [[Office of Population Research]] at [[Princeton University]] and the Association of Reproductive Health Professionals.
| |
| * [http://www.cecinfo.org/ International Consortium for Emergency Contraception]
| |
| * [http://www.go2ec.org/ Go 2 EC] – Emergency Contraception News
| |
| * [http://www.mapconspiracy.org The Morning-After Pill Conspiracy] – A United States group whose goal is to have Plan B available over the counter (not just behind pharmacy counters) to women of all ages. | | * [http://www.mapconspiracy.org The Morning-After Pill Conspiracy] – A United States group whose goal is to have Plan B available over the counter (not just behind pharmacy counters) to women of all ages. |
| | | |
| | | |
| {{BirthControl}} | | {{BirthControl}} |
| | {{WikiDoc Help Menu}} |
| | {{WikiDoc Sources}} |
|
| |
|
| [[Category:Chemical contraception]] | | [[Category:Chemical contraception]] |
| [[Category:Hormonal contraception]] | | [[Category:Hormonal contraception]] |
|
| |
| [[de:Pille danach]]
| |
| [[es:Anticonceptivo de emergencia]]
| |
| [[fr:Pilule du lendemain]]
| |
| [[ko:사후 피임약]]
| |
| [[it:Pillola del giorno dopo]]
| |
| [[nl:Morning-afterpil]]
| |
| [[no:Nødprevensjon]]
| |
| [[pt:Contracepção de emergência]]
| |
| [[fi:Jälkiehkäisy]]
| |
| {{WikiDoc Help Menu}}
| |
| {{WikiDoc Sources}}
| |