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On April 5, 2013, Federal District Judge Edward Korman directed the FDA to remove the age restriction on levonorgestrel-containing emergency contraceptive (EC) pills within 30 days, thereby allowing single-dose 1500-µg levonorgestrel — currently marketed in the U.S. as Plan B One-Step and the generic Next Choice One Dose — to be available over the counter to those of any age (JW Womens Health Apr 11 2013). Abundant evidence shows that this form of contraception is not associated with serious adverse effects. In >50 countries, levonorgestrel EC has long been available without prescription — moreover, better access to EC does not increase sexual risk taking or acquisition of sexually transmitted infections (JW Pediatr Adolesc Med Feb 14 2007). These pills have sometimes been confused with mifepristone (an antiprogestin that is abortifacient), but levonorgestrel (a progestin) has no adverse effects on established pregnancies and no long-term deleterious effects on fertility. Prompt postcoital access to this agent is important because its efficacy declines rapidly after administration (although a single dose of levonorgestrel has some efficacy when given as long as 5 days after unprotected intercourse).1 Levonorgestrel EC is safer and more effective than the Yuzpe regimen (2 doses of 2 to 4 oral contraceptive pills containing ethinyl estradiol and either norgestrel or levonorgestrel) — moreover, Preven, a dedicated EC product approved in 1998 that contains two doses of 100-µg ethinyl estradiol and 500-µg levonorgestrel, was withdrawn from the U.S. market in 2004.
Although having EC pills available without a prescription is appealing for its convenience and privacy, we must recognize that this status is unlikely to substantially lower rates of undesired pregnancy. Multiple studies have shown that, even when women are provided with free EC pills in advance of need, few use such pills after every act of unprotected intercourse.2 In addition, levonorgestrel EC pills are minimally effective for women who weigh more than 154 lb (70 kg) or who engage in repeated acts of unprotected intercourse.3 Given that the majority of U.S. women of reproductive age are overweight, this is a serious limitation. Also, although the over-the-counter status of levonorgestrel EC has been supported by women's health advocates, the Affordable Care Act will only cover this agent if it has been prescribed.
The EC ulipristal acetate (marketed as ella) requires a prescription, but is more effective than levonorgestrel — especially for obese women and in situations when more time has passed since unprotected sex. Like progestins, ulipristal acetate does not raise risk for venous thrombosis and is safe for women of all ages; however, it is still less effective in obese women than in normal-weight women, as well as after repeated acts of unprotected intercourse.3 Combining EC pills with daily use of a COX-2 inhibitor (e.g., celecoxib 400 mg4), which has been shown to increase ovulatory dysfunction, might enhance the effectiveness of oral EC regimens; however, this has not been formally studied.
The most effective form of EC is a copper intrauterine device (IUD) placed within 5 days of unprotected sex.5 The copper IUD is at least tenfold more effective than pills at preventing pregnancy, and a single copper IUD can protect a woman from undesired pregnancy for as many as 12 years or longer. Two studies showed that 12% to 15% of U.S. women seeking EC would have been interested in same-day placement of an IUD had the option been available to them.6,7 Women seeking EC who choose copper IUDs over EC pills are more likely still to be using highly effective contraception and less likely to become pregnant within 6 months of seeking EC.8 When indicated, cervical infection screening can be performed at the time of IUD placement.9 The International Consortium for Emergency Contraception recently developed a fact sheet on the use of this IUD for EC. In many countries, copper IUDs are relatively inexpensive; in the U.S., the Affordable Care Act now promises all women access to the contraceptive of their choice without copay. However, the shortage of clinicians trained to place IUDs — as well as the often-limited access to IUDs in the office setting — continues to constrain women's contraceptive options.
As we laud this long-overdue action toward a policy change that augments women's access to levonorgestrel EC, clinicians must recommit to offering their patients access to the most effective ways to avoid undesired pregnancy. In 2006, <10% of U.S. women had ever used EC,10 although one in three women have had an induced abortion by age 45. This should motivate providers to offer EC not only to women who seek it, but to all women who may have had recent unprotected intercourse and do not desire pregnancy. Furthermore, the EC visit is an appropriate time to initiate ongoing contraception. Given that these women are at high risk for unintended pregnancy, offering other highly effective contraceptive methods such as the etonorgestrel implant and the levonorgestrel IUD is important. Our patients deserve accurate information and easy access to all postcoital contraceptive options, not just those available over the counter.
von Hertzen H et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: A WHO multicentre randomized trial. Lancet 2002 Dec 7; 360:1803. (http://dx.doi.org/10.1016/S0140-6736(02)11767-3)
Polis CB et al. Advance provision of emergency contraception for pregnancy prevention. Cochrane Database Syst Rev 2007; Issue 2:CD005497. (http://dx.doi.org/10.1002/14651858.CD005497.pub2)
Glasier A et al. Can we identify women at risk of pregnancy despite using emergency contraception? Data from randomized trials of ulipristal acetate and levonorgestrel. Contraception 2011 Oct; 84:363. (http://dx.doi.org/10.1016/j.contraception.2011.02.009)
Edelman AB et al. Impact of the prostaglandin synthase-2 inhibitor celecoxib on ovulation and luteal events in women. Contraception 2013 Mar; 87:352. (http://dx.doi.org/10.1016/j.contraception.2012.07.004)
Cleland K et al. The efficacy of intrauterine devices for emergency contraception: A systematic review of 35 years of experience. Hum Reprod 2012 Jul; 27:1994. (http://dx.doi.org/10.1093/humrep/des140)
Schwarz EB et al. Interest in intrauterine contraception among seekers of emergency contraception and pregnancy testing. Obstet Gynecol 2009 Apr; 113:833. (http://viajwat.ch/Z3tfmi)
Turok DK et al. A survey of women obtaining emergency contraception: Are they interested in using the copper IUD? Contraception 2011 May; 83:441. (http://dx.doi.org/10.1016/j.contraception.2010.08.011)
Turok DK et al. A pilot study of the Copper T380A IUD and oral levonorgestrel for emergency contraception. Contraception 2010 Dec; 82:520. (http://dx.doi.org/10.1016/j.contraception.2010.06.001)
Sufrin CB et al. Neisseria gonorrhea and Chlamydia trachomatis screening at intrauterine device insertion and pelvic inflammatory disease. Obstet Gynecol 2012 Dec; 120:1314. (http://viajwat.ch/17GLcKm)
Kavanaugh ML et al. Emergency contraception use and counseling after changes in United States prescription status. Fertil Steril 2011 Jun 30; 95:2578. (http://dx.doi.org/10.1016/j.fertnstert.2011.03.011)