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Emergency contraception

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Emergency contraception
Background
B.C. type Hormonal (progestin or others) or intra-uterine
First use  ?
Failure rates (per use)
Perfect use IUD under 1%
ECP 25%
Typical use  ?%
Usage
User reminders Pregnancy test required if no period seen after 3 weeks
Clinic review Recommended to consider need screen STDs or consider ongoing routine contraceptive options
Advantages
Benefits IUDs may be subsequently left in place for ongoing contraception
Disadvantages
STD protection No
Periods ECP may disrupt next menstrual period by couple days. IUDs may make menstruation heavier and more painful
Weight gain No
Risks As per methods
Medical notes
Combined estrogrogen/progestin pills of Yuzpe regimen now superseded by better tolerated and more effective progestin-only pill.
ECP licensed for use within 3 days of unprotected intercourse and IUDs within 5 days.
Image:Wikinews-logo.png

Emergency contraception (EC) (also known as Emergency Birth Control (EBC), the morning-after pill, or postcoital contraception) refers to measures that, if taken after sex, may prevent pregnancy.

Forms of EC include:

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 with fertilisation, and therefore consider EC to be an abortifacient. These claims remain controversial; see below.

Contents

[edit] ECPs

Emergency contraceptive pills may contain higher doses of the same hormones (estrogens and progestins) found in regular oral contraceptive pills. Taken after 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; ECP's are licensed for use until 72 hours after sexual intercourse.

[edit] 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">Trussell, James; Wynn, Lisa (2006-11-11). Emergency Contraceptive Pills Worldwide. Princeton University. Retrieved on 2006-12-02.</ref> It is possible to obtain the same dosage of hormones, and therefore the same effect, by taking a large number of regular progestin-only oral contraceptive pills. For example, 40 Ovrette mini pills are equal to 2 Plan B pills.<ref>Ovrette. Retrieved on 2006-11-09.</ref> <ref name="dose">Doses of oral contraceptives that can be used for emergency contraception in the United States. Retrieved on August 2, 2006.</ref> The FDA has not approved this use of regular progestin-only oral contraceptive pills.

The combined or Yuzpe regimen uses large doses of both estrogen and progestin, taken as two doses at 12-hour intervals. This method is now believed less effective and well-tolerated than the progestin-only method.<ref name="who_epoc">WHO Task Force on Postovulatory Methods of Fertility Regulation. Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Lancet 1998;352:428-433. (Abstract)</ref> It is possible to obtain the same dosage of hormones, and therefore the same effect, by taking several regular combined oral contraceptive pills. For example, 4 Ovral pills are the same as 4 Preven pills.<ref name="dose"/> <ref>Ovral. Retrieved on 2006-12-02.</ref> The FDA approved this use regular combination oral contraceptive pills in 1997.

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>Planned Parenthood - Mifepristone: Expanding Women's Options for Early Abortion. Retrieved on July 23, 2006.</ref> but in China it is commonly used as an ECP. As ECP, a low dose of mifepristone is slightly less effective than higher doses, but has fewer side effects.<ref>Piaggio G et al (2003). "Meta-analysis of randomized trials comparing different doses of mifepristone in emergency contraception". Contraception 68 (6). PMID 14698075.</ref> As of 2000, the smallest dose available in the USA was 200 mg.<ref>Wertheimer, Randy E. (2000-11-15). "Emergency Postcoital Contraception" (HTML). American Family Physician. Retrieved on 2006-07-23.</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>Gemzell-Danielsson, K., Marions, L. (2004-06-10). "Mechanisms of action of mifepristone and levonorgestrel when used for emergency contraception" (HTML). Human Reproduction Update 10 (4): 341-348. Retrieved on 2006-07-23.</ref> but understanding of the mechanism of action remains incomplete. Higher doses of mifepristone can disrupt implantation and, unlike levonorgestrel, mifepristone is effective in terminating established pregnancies.

[edit] Effectiveness of ECPs

The effectiveness of emergency contraception is expressed as a percentage reduction in probable pregnancy rate for a single use of EC. Clinical placebo-controlled trials that could give a precise measure of effectiveness for EC would be unethical, so the effectiveness percentage is estimated; the progestin-only regimen is approximately 75% effective.[citation needed] An article in American Family Physician explains the effectiveness of the Yuzpe method this way:

Two reviews of the published literature concluded that the effectiveness rate of the combination method ranges between 55 and 94 percent, with a weighted average of 70 to 74 percent. Because the observed number of pregnancies in these studies is likely to be underestimated, the true effectiveness rate is likely to be at least 75 percent. It is important to communicate to patients that 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">Weismiller D (2004). "Emergency contraception.". Am Fam Physician 70 (4): 707-14. PMID 15338783. Retrieved on 2006-12-1.</ref>

Levonorgestrel ECP's may prevent at least 50% of expected pregnancies among women who take them correctly;<ref>Raymond E, Taylor D, Trussell J, Steiner M (2004). "Minimum effectiveness of the levonorgestrel regimen of emergency contraception.". Contraception 69 (1): 79-81. PMID 14720626.</ref> the current FDA-approved product labelling states that they can prevent 89% of expected pregnancies.<ref name="Plan B PI 2004">Duramed Pharmaceuticals, Inc. (Feb 2004). Plan B Full Prescribing Information (PDF). Retrieved on 2006-11-28.</ref> Until 1998, the Yuzpe regime of ECPs was believed to reduce expected pregnancies by about 75%, <ref name="Preven">Gynetics Inc (9 Jan 1998). Preven Emergency Contraceptive Kit (PDF). Product labels. FDA. Retrieved on 2006-11-09.</ref> but is now believed to reduce only 57%.<ref name="levoyuz">"Levonorgestrel is more effective, has fewer side-effects, than Yuzpe regimen.". Prog Hum Reprod Res: 3-5. PMID 12349416.</ref>

The effectiveness of emergency contraception is highest when taken within 12 hours of intercourse and declines over time.<ref> (1999) "Counsel women to take ECPs as soon as possible.". Contracept Technol Update 20 (7): 75-7. PMID 12295381.</ref><ref name="levoyuz"/> The limit of 72 hours is based on a study by the World Health Organization (WHO).<ref name="who_epoc" /> A subsequent WHO study has suggested that reasonable effectiveness continues for up to 120 hours (5 days).<ref>von Hertzen H, Piaggio G, Ding J, Chen J, Song S, Bártfai G, Ng E, Gemzell-Danielsson K, Oyunbileg A, Wu S, Cheng W, Lüdicke F, Pretnar-Darovec A, Kirkman R, Mittal S, Khomassuridze A, Apter D, Peregoudov A (2002). "Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial.". Lancet 360 (9348): 1803-10. PMID 12480356.</ref> However, many doctors (particularly in the U.K.) advise use of an IUD rather than ECP's for emergency contraception between 72 and 120 hours.

Because women in clinical trials of EC are likely to face higher pregnancy risk than the general population, the estimated number of pregnancies averted by treatment may be overestimated. Variables which can affect EC effectiveness other than the 8% "adjusted day of unprotected intercourse" include regularity of menstrual cycle, recent hormone use such as oral contraceptives, breastfeeding, and the number of acts of unprotected intercourse.<ref>Westley E et al (2006). "Risk of pregnancy and external validity in clinical trials of emergency contraception". J Fam Plann Reprod Health Care 32 (3). PMID 16857070.</ref> The effectiveness estimates of emergency contraception may also be overestimated because the calendar method of fertility awareness--used in trials to estimate the number of fertile women and the number of expected pregnancies--is not highly accurate. In an analysis of hormone blood test data taken from trial subjects in an EC effectiveness study, far fewer of the women surmised to be fertile were actually fertile. <ref>Espinos JJ et al (1999). "The Role of Matching Menstrual Data with Hormonal Measurements in Evaluating Effectiveness of Postcoital Contraception". Contraception 60 (4). PMID 10640171.</ref>

[edit] Controversy in estimating EC effectiveness

The original method of calculating the failure rate of EC was to divide the number of observed pregnancies by the number of women treated. This produced failure rates of below 1% for diethylstilbestrol and 0.16-5% for combined estrogen-progestin. In 1991, researchers argued in an article called "Postcoital contraception: Myth or reality?" that these failure rates were serious underestimates, because 100 women is unlikely to equal 100 pregnancies. They reconfigured the failure rates in a meta-analysis of the studies, which used conception probabilities to determine how many women in an average 100 are at risk of pregnancy, and concluded that the failure rates for EC ranged from 44-100% for combined estrogen-progestin. <ref>Silvestre L, Bouali Y, Ulman A (1991). "Postcoital contraception: myth or reality?". Lancet 338 (8758). PMID 1676094.</ref> In 1996, the published failure rates of EC were calculated using conception probabilities based on the calendar method. <ref>Trussell J, Ellertson C, Stewart F (Mar/April 1996). The effectiveness of the Yuzpe regimen of emergency contraception. Family Planning Perspectives. Retrieved on 2006-11-07.</ref>

[edit] Abortion rates and EC

The availability of ECP's has not been shown to lower abortion rates. In France, Sweden, and the U.K.—where EC has been available for more than a decade—the abortion rate was stable or higher during that time period.<ref>Emergency Contraception Doesn't Lower Abortion Rates. Forbes (Sep 15, 2006). Retrieved on 2006-09-23.</ref> A study conducted to determine if distribution of free, advance supplies of EC to large numbers of women in Scotland could lower abortion rates concluded that it did not. <ref>Glasier A, Fairhurst K, Wyke S, Zieblad S, Seaman P, Walker J, Lakha F (2004). "Advanced provision of emergency contraception does not reduce abortion rates". Contraception 69 (5). PMID 15105057.</ref> According to EC expert Anna Glasier, EC is "better than nothing" and "worth the fuss... if you are a woman who has had unprotected sex," because "it will work in some women some of the time," but is not a useful public health measure. She stated that "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." <ref>Glasier, A (Sep 2006). "Emergency contracpetion: Is it worth all the fuss?". BMJ 333 (7568). PMID 16973989.</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>Hu X et al (2005). "Advanced provision of emergency contraception to postnatal women in China makes no difference in abortion rates: a randomized controlled trial". Contraception 72 (2). PMID 16022849.</ref>

[edit] ECPs as ongoing contraception

There is one brand of levonorgestrel pills (Postinor), which is marketed as an ongoing method of postcoital contraception.<ref name="beyond coca-cola">Ellertson, Charlotte (March/April 1996). "History and Efficacy of Emergency Contraception: Beyond Coca-Cola". Family Planning Perspectives 28 (2). Retrieved on 2006-11-22.</ref> However, there are serious drawbacks to such use of emergency contraception:

  • 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>Chernev T, Ivanov S, Dikov I, Stamenkova R (1995). "Prospective study of contraception with levonorgestrel.". Plan Parent Eur 24 (2): 25. PMID 12290800.</ref>
  • Used according to package directions (up to 72 hours after intercourse), levonorgestrel emergency contraceptive pills are estimated to have a perfect-use pregnancy rate of 20% per year - 40% annual pregnancy rate for the Yuzpe regimen.<ref name="princeton">Effectiveness of Emergency Contraceptives. The Emergency Contraception Website. Office of Population Research at Princeton University and the Association of Reproductive Health Professionals (November 2006). Retrieved on 2006-12-2.</ref> These failure rate are higher than that of almost all other birth control methods, including the Rhythm Method and withdrawal. (Recommended use of Postinor is to take the pills within one hour of intercourse).<ref name="pkjfm">Bakhtiar, Saadia, Mehboob Ashraf (May 2000). "Contraception". Pakistan Journal of Family Medicine 11: 19-24. Retrieved on 2006-12-2.</ref>
  • Like all hormonal methods, emergency contraceptive pills do not protect against sexually transmitted infections.<ref name="princeton2">What is Emergency Contraception?. The Emergency Contraception Website. Office of Population Research at Princeton University and the Association of Reproductive Health Professionals (November 2006). Retrieved on 2006-12-2.</ref>

ECPs are recommended for backup or "emergency" use, rather than as the sole 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" />

[edit] Contraindications

[edit] Pregnancy

Plan B and Yuzpe should not be used by women who are already pregnant, because they are not effective after implantation.<ref name="aap_ec">American Academy of Pediatrics Committee on Adolescence (2005). "Emergency contraception". Pediatrics 116 (4): 1026-35. PMID 16147972.</ref>

[edit] Estrogen risks

Because they contain estrogen, combined estrogen-progestin emergency contraception (Yuzpe regimen) pills should not be used by women with a history of heart attack, stroke, blood clots, breast cancer, or patients with severe liver disease or the very rare condition of porphyria.[citation needed]

[edit] Breast cancer, levonorgestrel, and estrogen

The WHO advises that current breast cancer is an absolute contraindication to high-dose progestin-only contraception.<ref>Levonorgestrel: Levonelle-2 (PDF). UK Drug Information Pharmacists Group (2000). Retrieved on 2006-11-16.</ref> Progestogen-only contraceptives have growth potentiating effects in the human mammary gland, as indicated by elevated rates of cell proliferation.<ref>Hormonal Contraceptives, Progestogens Only. IARC (1999). Retrieved on 2006-11-16.</ref> An in vitro study found that levonorgestrel increased the vascular endothelial growth factor in T47-D breast cancer cells.<ref>Mirkins S, Wong BC, Archer DF (Sept/Oct 2006). "Effects of 17-beta estradiol, progesterone, progestins, tibolone, and raloxifene on vascular endothelial growth factor". Int J Gynecol Cancer 16 (2). PMID 17010073.</ref> In a large cohort study, users of combined estrogen-levonorgestrel contraceptive pills had an increased risk of breast cancer which paralleled the increasing dose of levonorgestrel. However, the exposure to estrogen was speculated to be the most important factor in increased risk. In women who used progestin-only pills, there was no increase in the risk of breast cancer, but the number of users was deemed too small to draw definitive conclusions.<ref>Dumeaux V, Alsaker E, Lund E (2003). "Breast cancer and specific types of oral contraceptives: a large Norwegian cohort study". Int J Cancer 105 (6). PMID 12767072.</ref> A different large cohort found that progestin-only pills increased breast cancer risk at the same level as combined pills.<ref>Kumle M, et al. "Use of oral contraceptives and breast cancer risk: the Norwegian-Swedish Women's Lifestyle and Health Cohort Study". Cancer Epidemiol Biomarkers Prev 11 (1375). PMID 12433714.</ref> The study authors stated that "the relationship between progestin-containing pills and breast cancer requires futher investigation."


[edit] Interactions

The herbal preparation of St John's wort and some enzyme-inducing drugs (e.g. anticonvulsants or rifampicin) may reduce the effectiveness of ECP, and a larger dose may be required. (Levonorgestrel 1500mcg initial dose and an extra 750 mcg after 12 hours).<ref>For women who are using liver enzyme inducing drugs, what dose of progestogen-only emergency contraception is advised? PDF members response 916 Faculty of Family Planning and Reproductive Health Care - Clinical Effectiveness Unit</ref>

[edit] Side effects

The most common side effects of emergency contraception pills are nausea, abdominal pain, fatigue, headache, dizziness, vomiting, and mastalgia. These side effects normally resolve within 24 hours. These effects are less for progestin-only pills compared to combined pills (only 23% of progestin-only users experience nausea, whereas 50% of combined pill users do). Estrogen in combined ECPs is responsible for the increased incidence of nausea and vomiting. Antiemetics may be prescribed for both methods. Consider antiemetics 1 hour before each ECP dose. If vomiting occurs within an hour after taking ECPs, it may be necessary to repeat the dose.

Temporary disruption of the menstrual cycle is also common and may manifest as early or late periods, spotting or breakthrough bleeding, and (less commonly) missed periods. The primary mechanism of EC is delaying ovulation. Menstruation occurs, on average, 14 days after ovulation, so delayed ovulation results in delayed menstruation. Suppression of ovulation may cause anovulatory bleeding, which could manifest as an early period.

[edit] Ectopic pregnancy

Ectopic pregnancies account for approximately 2% of reported pregnancies. Up to 10% of pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic. Progestins can slow the intratubal migration of fertilized ovum, which may explain the possible increased risk. <ref>Furlong LA (2002). "Ectopic pregnancy risk when contraception fails: A review". J Reprod Med 47 (11). PMID 12497674.</ref> A history of ectopic pregnancy need not be considered a contraindication to use of levonorgestrel EC, but consumers and health providers should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking levonorgestrel EC. <ref>Nielson C, Miller L (2000). "Ectopic gestation following emergency contraceptive pill administration". Contraception 62 (5). PMID 11172799.</ref> <ref>Basu A, Candalier C (2005). "Ectopic pregnancy with postcoital contraception--a case report" 10 (1)page=6-8). PMID 16036291.</ref> Following the discovery that one in twenty pregnancies resulting after Levonelle failure were ectopic, the product labelling was changed and an update was issued to physicians in the UK to warn patients of the risk. <ref>{{cite web}title=Morning after pill to carry new warning on ectopic pregnancy|publisher=bmj.com|date=January 30, 2003|accessdate=2006-11-09|url=http://www.bmj.com/uknews/news20030130.shtml#2}}</ref>Ectopic pregnancy is a medical emergency which can be fatal.

[edit] Postmarketing Surveillance

The postmarketing surveillance for Plan B and Levonelle reports adverse reactions which are mostly nonserious, and which are described in the product labeling. Serious adverse reactions included:<ref name="postmarket">CDER (Sept 30, 2003). ODS Postmarketing Safety Review (PDF). FDA. Retrieved on 2006-11-07.</ref>

  • Three cases of convulsions, including a grand mal seizure in a patient with no history of epilepsy. The other two cases occurred in epileptics, and are surmised to be attributable to drug-interaction. (Antiepileptic drugs may alter the metabolism of most hormonal methods of contraception). <ref>O'Brien MD, Guillebaud J (2006). "Contraception for women with epilepsy". Epilepsia 47 (9). PMID 16981856.</ref>
  • Ten cases of hypersensitivityreaction, seven of which were considered life-threatening. The current Plan B labelling does not address hypersensitivity reactions.

[edit] Confirmation of Results

A pregnancy test is the only reliable way to confirm that EC has been effective. EC can cause menstrual changes that are similar to early signs of pregnancy, and some doctors therefore advise all women who take EC to take a pregnancy test afterwards to confirm results.

Pregnancy tests will not give positive results until after an embryo has implanted, which occurs six to twelve days after ovulation.<ref>Wilcox A, Baird D, Weinberg C (1999). "Time of implantation of the conceptus and loss of pregnancy.". N Engl J Med 340 (23): 1796-9. PMID 10362823.</ref> The most sensitive tests can detect pregnancy the day after implantation, so the earliest a positive result would be seen would be one week after intercourse (assuming intercourse occurred on the day of ovulation). Sperm life of up to five days is considered normal,<ref name="tcoyf">Weschler, Toni (2002). Taking Charge of Your Fertility, Revised Edition, New York: HarperCollins, p.374. ISBN 0-06-093764-5.</ref> and less sensitive tests may not detect pregnancy until three to four days after implantation. So a pregnancy test may give false negatives up to three weeks after intercourse (five days between intercourse and ovulation, twelve days between ovulation and implantation, four days between implantation and detectable levels of the pregnancy hormone hCG).

[edit] Risky Sex

Whether EC use is associated with increases in sexual risk taking is unclear--some studies show a correlation; some do not. Between 1999 and 2004 in Sweden, the use of emergency contraceptive pills by female university students more than doubled. During the study period, there was a trend towards more risky sexual behavior with more partners, more unprotected first-date intercourse, and more self-reported sexually transmitted infections. <ref>Larsson M, Tyden T (2006). "Increased sexual risk taking behavior and Swedish university students: repeat cross-sectional surveys". Acta Obstet Gynecol Scand 85 (8). PMID 16862476.</ref> Teen sexually transmitted infections have increased in Sweden since emergency contraception has been available over the counter. During this same period, Sweden has undergone a decrease in sex education, economic stagnation, and increases in drug use and school non-attendance, which may also play a role.<ref>Edgardh, K (2003). "Adolescent sexual health in Sweden". Sex Trans Infect 78 (5). PMID 12407239.</ref> At least one study has found that when emergency contraception is available, the incidence of unprotected sex does not increase.<ref>Norris Turner A, Ellertson C (2002). "How safe is emergency contraception?". Drug Saf 25 (10): 695-706. PMID 12167065.</ref> In the US, the issue has been hotly debated with regards to whether EC should be available over-the-counter for teens. FDA official Janet Woodcock claimed that easy access for teens would result in promiscuity, but a US study has shown that teens are not more likely to engage in unprotected sex than young adults are, when both have advance access to EC. <ref> Raine et al., Journal of the American Medical Association 293(1):54-62.[1]. (2000).</ref>

[edit] Intrauterine device used 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>Gottardi G, Spreafico A, de Orchi L (1986). "The postcoital IUD as an effective continuing contraceptive method.". Contraception 34 (6): 549-58. PMID 3549140.</ref>

[edit] History

Interest in synthetic hormones as postcoital contraceptives originated several decades ago, with the first published study on the subject appearing in 1967.<ref> (1967) "Postcoital contraception.". IPPF Med Bull 1 (4): 3. 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 ongoing contraceptive method.<ref>Demers L (1971). "The morning-after pill.". N Engl J Med 284 (18): 1034-6. 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> (1973) "FDA considers DES safe as 'morning-after' pill.". JAMA 224 (12): 1581-2. PMID 12257949.</ref><ref>Johnson JH (1984). "Contraception-the morning after". Fam Plann Perspect 16 (6). PMID 6519238.</ref>

In the early 1970s, the Yuzpe regimen was developed by AA Yuzpe (1974);<ref>Yuzpe A, Thurlow H, Ramzy I, Leyshon J (1974). "Post coital contraception--A pilot study.". J Reprod Med 13 (2): 53-8. PMID 4844513.</ref> progestin-only postcoital contraception was investigated (1975);<ref>Valle G (1975). "The problem of postcoital contraception using oral progestins". Aggiorn Ostet Ginecol 8 (3): 127-8. PMID 12334868.</ref> and the copper IUD was first studied for use as emergency contraception (1975).<ref> (1975) "Copper IUD, inserted after coitus averts pregnancy and provides continuing contraceptive protection.". Int Fam Plann Dig 1 (3): 11-2. 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>Error on call to Template:cite web: Parameters url and title must be specified. Medscape (2002). Retrieved on 2006-11-08.</ref>

The Yuzpe regimen became the standard course of treatment for postcoital contraception in many countries in the 1980s, and several dedicated products were produced between the mid 1980s and the late 1990s.

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>Sponsors. Fertility (2002). Retrieved on 2006-12-1.</ref> After the WHO conducted a large trial comparing Yuzpe and levonorgestrel in 1998,<ref>Task Force on Postovulatory Methods of Fertility Regulation (1998). "Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraception for emergency contraception". Lancet 352 (9126). PMID 9708750.</ref><ref>Guillebaud J (1998). "Time for emergency contraception with levonorgestrel alone". Lancet 352 (9126). 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 the combination pills are still available in many countries.

[edit] 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">International Consortium for Emergency Contraception (ICEC) webpage, section on "History". Accessed 30 Nov 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">ICEC web page, section on "Products and Availability". Accessed 30 Nov 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>Concept Foundation. Initative on Public-Private Partnerships for Health (March 7, 2006). Retrieved on 2006-11-17. 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>IPPF Launches New EC Pill at ICEC Meeting. Consortium News (October, 2006). Retrieved on 2006-11-17.</ref>

[edit] EC and sexual assault

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>Glover D eta al (1976). Diethylstilbestrol in the treatment of rape victims. West J Med. Retrieved on 2006-11-09.</ref> <ref>Diamond EF (1978). "Physician notes hazards of DES use to prevent pregnancy". Hosp Prog 59 (3). 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>Stewart, Felicia H., James Trussell. (November 2000). "Prevention of pregnancy resulting from rape: A neglected preventive health measure". American Journal of Preventive Medicine 19 (4). DOI:10.1016/S0749-3797(00)00243-9. PMID 11064225. Retrieved on 2006-08-23.</ref> Abortions because of rape account for less than one percent of all annual abortions. <ref>Finer, Lawrence B., Lori F. Frohwirth, Lindsay A. Dauphinee, Susheela Singh, and Ann M. Moore (September 2005). "Reasons U.S. Women Have Abortions: Quantitative and Qualitative Perspectives". Perspectives on Sexual and Reproductive Health 37 (3): 110-118. PMID 16150658. Retrieved on 2006-08-23.</ref>

[edit] Controversy

[edit] Emergency contraception, implantation, and abortion politics

See also: Beginning of pregnancy controversy

A number of studies in the 1970s and 80s concluding that emergency contraception could cause changes in the endometrium,<ref>Ling WY, Robichaud A, Zayid I, Wrixon W, MacLeod SC (1983). "Mode of action of dl-norgestrel and ethinylestradiol combination in postcoital contraception". Fertil Steril 40 (5): 631-6. PMID 6628707.
Kubba AA, White JO, Guillebaud J, Elder MG (1986). "The biochemistry of human endometrium after two regimens of postcoital contraception: a dl-norgestrel/ethinylestradiol combination or danazol". Fertil Steril 45 (4): 512-516. PMID 3956767.
Yuzpe AA, Thurlow HJ, Ramzy I, Leyshon JI (1974). "Post coital contraception—a pilot study". J Reprod Med 13 (2): 53-8. PMID 4844513.</ref> and thus preventing implantation of an early stage embryo in the uterus, led many pro-life advocates who believe that pregnancy begins at fertilisation, to oppose ECPs as an abortifacient.

In recent years--especially in light of U.S. controversy over this possibility--the scientific community has begun to critically reevaluate the claim, 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"> (May 2005) "Article Emergency Contraception's Mode of Action Clarified". Population Briefs 11 (2). Retrieved on 2006-08-27.</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">Durand M, del Carmen Cravioto M, Raymond EG, Duran-Sanchez O, De la Luz Cruz-Hinojosa M, Castell-Rodriguez A, Schiavon R, Larrea F (2001). "On the mechanisms of action of short-term levonorgestrel administration in emergency contraception". Contraception 64 (4): 227-34. PMID 11747872.</ref> suggesting that might be the only mechanism by which they prevent pregnancy.

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 pre-implanted embryos inside the uterus and fallopian tubes, both sides of this debate concede that completely proving or disproving the theory may be impossible.<ref>Bollinger, Caroline. The Post-Fertilization Effect: Fact or Fiction?. Prevention.com. Retrieved on 2006-08-26.</ref><ref name="mechanism article" />

The Food and Drug Administration recently stopped its practice <ref>FDA's Decision Regarding Plan B: Questions and Answers. Center for Drug Evaluation and Research (2004-05-07). Retrieved on 2006-08-25.</ref> of referring to all three mechanisms in its publications on emergency contraception. <ref>FDA's Decision Regarding Plan B: Questions and Answers: August 24, 2006. Center for Drug Evaluation and Research (2006-08-24). Retrieved on 2006-08-25.</ref> However, the approved box design for Plan B still carries a notification that it may prevent implanation. <ref>Galson, Stephen (2006-08-24). Notification to Duramed Research, Inc. of FDA Approval of Plan B (PDF). Center for Drug Evaluation and Research. Retrieved on 2006-08-25.</ref>

When used as a regular method of contraception, IUDs have been proven to act primarily through spermicidal and ovicidal mechanisms, but it is theoretically possible that these same mechanisms are also harmful to pre-implanted embryos.<ref>Mechanisms of the Contraceptive Action of Hormonal Methods and Intrauterine Devices (IUDs). Family Health International (2006). Retrieved on 2006-07-05.
Keller, Sarah (Winter 1996, Vol. 16, No. 2). IUDs Block Fertilization. Network. Family Health International.</ref>

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.

[edit] United States legal and ethical controversies

  • A Massachusetts law that went into effect on 14 December, 2005, requires all hospitals 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. "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 UN/WHO Inter-agency Field Manual on Reproductive Health in Refugee Situations, the Catholic Church explains its belief that emergency contraception, along with IUDs and hormonal contraception, cannot be considered "solely contraceptive because in the case of effective fertilisation a chemical abortion would be carried out during the first days of pregnancy."<ref>Barragán, Javier L., Hamao, Stephen F., and Trujillo, Alfonsocard L. 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>"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 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>The Limits of Conscientious Objection - May Pharmacists Refuse to Fill Prescriptions for Emergency Contraception?. NEJM (November 4, 2004). Retrieved on 2006-11-13.</ref>
  • In 2002, the FDA's Division of Drug Marketing, Advertising, and Communications sent a warning letter to the license-holder of Plan B, citing their direct-to-consumer ads as "false, lacking in fair balance or otherwise misleading, in violation of the Federal Food, Drug, and Cosmetic Act." FDA noted, "Specifically, the direct-to-consumer print and radio ads overstate efficacy, fail to convey important limitations on use, and minimize important information about risks associated with the use of Plan B. As a result, the ads raise significant public health and safety concerns." <ref>CDER (2002). Warning Letters and Untitled Letters to Pharmaceutical Companiess 2002. FDA. Retrieved on 2006-11-07.</ref>

[edit] International availability

[edit] Europe

[edit] United Kingdom

In 1984, Schering PC4 was approved. Levonelle was launched in 2000; and became available without prescription in 2001 for women 16 and older. This was challenged by a pro-life group, but the High Court of Justice of England and Wales let the rule stand in April 2002. In 2005, Levonelle One Step--a new regimen of one pill instead of two--replaced Levonelle. <ref>Contraception: past, present and future. UK Family Planning Association (April, 2006). Retrieved on 2006-11-09.</ref>

[edit] France

Oral contraceptive pills have been used as EC in France since the 70s. Tetragynon was approved in 1998. Norlevo was approved in 1999, with pharmacy access. (France does not have an over-the-counter status equivalent.) In 2000, public and parochial high school nurses were allowed to dispense Norlevo in schools. <ref>Emergency contraception: Steps being taken to improve access. Guttmacher Institute (Dec 2002). Retrieved on 2006-11-11.</ref>

[edit] Netherlands

Ethinyl estradiol was used as the primary method of EC from the 1960s to the 1980s (its popularity peaked in 1975). In 1982, the Yuzpe regimen compared favorably in a double-blind randomized controlled trial and became the obvious method of choice.<ref>Haspels AA (1994). "Emergency contraception: a review". Contraception 50 (2). PMID 7956209.</ref> Since January 2005, levonorgestrel-only EC (NorLevo 1.5 mg) has been available over-the-counter without a prescription in pharmacies and drug stores.

[edit] Finland

The Yuzpe regimen was introduced under the name Neoprimavlar in 1987.

[edit] North America

[edit] United States

DES (diethylstilbestrol) was approved for use as EC in 1973. DES was approved in spite of its known carcinogenic effects on the fetus (adult women who were exposed to the drug in utero have significantly increased risk of certain cancers). Given the risk of DES-related cancer in exposed offspring,<ref>Dolores Ibarreta, Shanna H. Swain (2001). The DES Story: long-term consequences of prenatal use (PDF). European Environmental Agency. Retrieved on 2006-11-13.</ref> the medical literature recommended that abortion be strongly considered if emergency contraception with DES failed.<ref> (1973) "Diethylstilbestrol as a "morning after" contraceptive.". Med Lett Drugs Ther 15 (14): 58-9. PMID 4740292.</ref> Whether this advice was given to patients is unclear. According to the National Women's Health Network, in 1975, "DES was being carelessly prescribed as a 'morning after pill.'" <ref>Nancy Berglas (Nov/Dec 1995). The First FDA Protest. NWHN. Retrieved on 2006-11-20.</ref> In 1978, the manufacturer of DES warned against its use as EC,<ref>Demarco JJ (1992). "Postcoital contraception: underrecognized and underutilized". Female patient 6 (24). PMID 12287765.</ref> and the following year the National Institutes of Health warned that DES should be used only if no viable alternatives were available.<ref>Richmond JB (1979). "Physician advisory: health effects of the pregnancy use of diethylstilbestrol". Clin Toxicol 14 (3). PMID 37020.</ref> Nonetheless, DES continued to be widely used as a first-line EC treatment through the 1980s,<ref>Tintinall JE, Hoelzer M (1985). "Clinical findings and legal resolution in sexual assault". Ann Emerg Med 14 (5). PMID 3985466.</ref><ref>Fischer RG (1985). "Postcoital contraception". Pediatr Nurs, abstract available at Popline database 11. PMID 3850481.</ref><ref>Brushwood DB (1990). "Must a Catholic hospital inform a rape victim of the availability of the "morning-after pill"?". Am J Hosp Pharm 47 (2). PMID 2309736.</ref> as it was believed to be more than 99% effective and was less expensive than the alternative, ethinyl estradiol.<ref>Noller K (1977). "The morning-after pill". Fertility and Sterility 28 (2). Popline database document number 770200.</ref> The primary US manufacturer of DES, Eli Lilly, ceased production of DES in 1997, after the FDA prohibited the use of banned drugs in pharmacy compounding.<ref>List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness. FDA (1998). Retrieved on 2006-11-14.</ref> The FDA endorsed the use of regular birth control pills (the Yuzpe method) as EC in 1997. Preven was approved in 1998—the same year a large WHO study determined that levonorgestrel was more effective—and was withdrawn from the market in 2004. Plan B (levonorgestrel) was approved for prescription-only use in 1999. In 2006, Plan B was approved for nonprescription behind-the-counter access from pharmacies staffed by a licensed pharmacist for women 18 or older.

[edit] United States Virgin Islands

The Yuzpe regimen and diethylstilbestrol are used on the island of St. Croix. <ref>If You've Been Sexually Assaulted. Women's Coalition of St. Croix (2005). Retrieved on 2006-11-16.</ref>

[edit] Canada

In 2000, Plan B was approved in Canada by prescription; in 2005 nationwide nonprescription behind-the-counter pharmacy access after professional consultation with a pharmacist was approved. <ref>Health Canada Approves Emergency Contraceptive Plan B as OTC Drug. Medical News Today (Apr 22, 2005). Retrieved on 2006-09-25.</ref>

[edit] New Zealand

In 1996, EC was approved for over the counter access, with the support of the Ministry of Health. The New Zealand Medical Association expressed serious reservations about OTC access to "such a powerful medication, because it could be used as normal contraception." Schering New Zealand, manufacturer of PC4, also opposed consumption of their product without medical consultation, because "...the pills may be used repeatedly and incorrectly, putting women at risk of very high dose contraception," and withdrew PC4 from the market in New Zealand. <ref>Williams C (1996). "New Zealand Doctors resist emergency contraception". BMJ 312 (7029). PMID 8597671.</ref> <ref>Elizabeth Westley (1998). Emergency Contraception: A Global Overview. JAMWA. Retrieved on 2006-11-17.</ref>

[edit] Australia

Postinor-2 and Levonelle-2 became available in 2002. In 2004, Postinor-2 became available without prescription. <ref>Emergency Contraception. FPA health (July 30, 2006). Retrieved on 2006-11-15.</ref>

[edit] Asia

[edit] China

Anordrin, an estrogenic steroid of the 19-Norandrostane family, was the most frequently used EC in China in 1997. <ref>Xiao B (1997). "Abortion and emergency contraception: the Chinese experience". Chin Med J 110 (1). PMID 9594319.</ref> Levonorgestrel EC in China is known as Yu-Ting and An Ting. In 2002, China became the first country in which mifepristone was registered for use as EC.

[edit] India

The Indian Medical Association advises that high doses of combined oral contraceptive containing ethinyl estradiol and levonorgestrel (Yuzpe regimen) and copper releasing IUDs such as CuT 380A can be used as EC, but the Drug Controller of India has only approved (in 2001) levonorgestrel 0.75 mg. tablets for use as ECP. On August 31, 2005, nonprescription, over-the-counter access to levonorgestrel-only EC was approved.

[edit] Sri Lanka

The Family Planning Association began offering the Yuzpe regimen in 1994.

[edit] Malaysia

Postinor was registered in 1987.

[edit] South America

[edit] Chile

Postinor-2 became legal in Chile in 2002 after a Supreme Court battle. <ref>Chile bans morning-after pill. BBC News (August 30, 2001). Retrieved on 2006-11-17.</ref> <ref>Eduardo Gallardo (September 26, 2006). Morning-After Pill Causes Furor in Chile. Washington Post. Retrieved on 2006-11-16.</ref> Affluent Chileans were able to purchase it on demand from private health services, but poorer Chileans served by the national health service were only given EC if they were sexual assault victims. <ref>A difficult pill to swallow. Economist (Sept 14, 2006). Retrieved on 2006-11-17.</ref> In 2006, access to EC was briefly allowed for all females 14 and over, but this was immediately blocked by a court decision. <ref>Daniela Estrada (Sept 13, 2006). Court Stops Free Distribution of "Morning After Pill". IPS. Retrieved on 2006-11-17.</ref> Months later an Appeals Court upheld a lower court decision to allow the Ministry of Health to distribute EC to minors without parental consent. <ref>Chile Court Okays Morning-After Pill. The Santiago Times (Nov 13, 2006). Retrieved on 2006-11-17.</ref>


[edit] Africa

[edit] South Africa

A Yuzpe product called E-Gen-C became available in 1997.

[edit] Kenya

Postinor became available in 1997.

[edit] Zambia

Levonorgestrel-only EC called Lenor 72 was registered in 2002; in 2005 another levonorgestrel-only product called Pregnon was registered.



[edit] Other Countries

Levonorgestrel emergency contraception is available in 101 countries, and is available without prescription in 33 of them, including: Albania, Australia, Belgium, Benin, Bulgaria, Cameroon, Colombia, Congo, Croatia, Denmark, Estonia, French Polynesia, Gabon, Ghana, Greece, Guinea-Conakry, Iceland, Israel, Ivory Coast, Jamaica, Latvia, Lithuania, Madagascar, Mali, Mauritania, Mauritius, Morocco, Mexico, Norway, Portugal, Romania, Senegal, Sweden, Switzerland, Togo, Tunisia, Turkey, Italy and Uruguay. [citation needed]

In Ireland it is available without restriction, but is not available over-the counter and requires a visit to a doctor of family-planning clinic. <ref>Irish Government Contraception site, noting the availability of EC</ref>

[edit] Footnotes

<references />

[edit] External links