The FDA has approved Opill (Perrigo), a progestin-only oral contraceptive that contains norgestrel, for sale over the counter (OTC). Opill is the first oral contraceptive to be approved in the US for sale without a prescription. Approval of OTC Opill is intended to increase access to effective contraception and reduce the rate of unintended pregnancies.

Intrauterine devices (IUDs) and the etonogestrel implant are the most effective reversible contraceptive methods available. Hormonal oral contraceptives, patches, rings, and injectables are also effective in preventing pregnancy. When used alone, barrier and behavioral methods generally have higher failure rates than other methods (see Table 1). Selection of a contraceptive method is usually based on patient-specific factors and personal preference

Oriahnn (Abbvie), a fixed-dose combination of the gonadotropin-releasing hormone (GnRH) receptor antagonist elagolix, the estrogen estradiol, and the progestin norethindrone acetate copackaged with elagolix alone, has been approved by the FDA for oral treatment of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. It is the first product to be approved in the US for this indication. Elagolix (Orilissa) has been available since 2018 for treatment of moderate to severe pain associated with endometriosis. The GnRH receptor antagonist relugolix (Orgovyx), which is approved for treatment of advanced prostate cancer, is being reviewed by the FDA for use in combination with estradiol and norethindrone acetate for the same indication as Oriahnn.

The FDA has approved Twirla (Agile Therapeutics), a transdermal contraceptive patch containing the estrogen ethinyl estradiol and the progestin levonorgestrel, for use in women with a BMI <30 kg/m². It is the second contraceptive patch to become available in the US; Xulane, a patch that delivers ethinyl estradiol and the progestin norelgestromin, has been available since 2014.

The FDA has approved Phexxi (Evofem), a nonhormonal prescription-only vaginal gel containing lactic acid, citric acid, and potassium bitartrate, for prevention of pregnancy. The gel is intended for on-demand contraception; it is not effective when used after intercourse. It was previously approved for use as a vaginal lubricant (Amphora), but was never marketed.

Intrauterine devices (IUDs) and the etonogestrel implant are the most effective reversible contraceptive methods available. Hormonal oral contraceptives, patches, rings, and injectables are also highly effective in preventing pregnancy. When used alone, barrier and fertility-based methods generally have higher failure rates than other methods.

The FDA has approved Kyleena (Bayer), an intrauterine device (IUD) that releases the synthetic progestin levonorgestrel, for prevention of pregnancy. It is the fourth levonorgestrel-releasing IUD to be approved in the US. Like Mirena, which has been available since 2000, Kyleena is approved for up to 5 years of use.

Implants, intrauterine devices (IUDs), and sterilization are the most effective contraceptive methods available. Pills, patches, rings, and injectables, when used correctly, are also highly effective in preventing pregnancy. Barrier and fertility-based methods have the highest rates of failure.

The FDA has approved Liletta, an intrauterine device (IUD) that releases the synthetic progestin levonorgestrel, for prevention of pregnancy for up to 3 years. The fourth IUD to be approved in the US, and the third that releases levonorgestrel, Liletta is comarketed by Actavis and Medicines360, a nonprofit women's health pharmaceutical company. The wholesale cost of Liletta is similar to that of other IUDs (see Table 1), but the manufacturer offers programs that significantly reduce the cost for commercially-insured patients and clinics serving low-income women.

The FDA recently approved Skyla (Bayer), the first new intrauterine device (IUD) in the US in 12 years. It releases levonorgestrel, a synthetic progestin, over a period of 3 years. A table summarizing contraceptive methods available in the US appears on page 22.

The FDA has announced that combination hormonal contraceptives (CHCs) containing the synthetic progestin drospirenone (Yaz, Yasmin, Beyaz, Safyral, and others) may be associated with a higher risk of thromboembolism than CHCs containing other progestins.1

The new warning was based partly on an unpublished, FDA-funded, retrospective study that found a 1.7-times higher risk of venous thromboembolism among US women who used a CHC that contained drospirenone than among women whose CHC contained levonorgestrel, norgestimate or norethindrone as the progestin component.2 As with all retrospective studies, unknowable confounding factors, such as why doctors prescribed one progestin over the other, could have distorted the results.

All CHCs increase the risk of venous thromboembolism; whether the progestin component affects the risk has been controversial. The Medical Letter and several other reviews and consensus statements have found no convincing evidence of an increased risk with drospirenone.3-5

1. FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone. Available at www.fda.gov/Drugs/DrugSafety/ucm299305.htm. Accessed April 23, 2012.

2. FDA. Combined hormonal contraceptives (CHCs) and the risk of cardiovascular disease endpoints. Available at www.fda.gov/downloads/Drugs/DrugSafety/ucm277384. Accessed April 23, 2012.

3. Combination oral contraceptives and the risk of venous thromboembolism. Med Lett Drugs Ther 2010; 52:23.

4. RL Reid. Oral contraceptives and venous thromboembolism: pill scares and public health. J Obstet Gynaecol Can 2011; 33:1150.

5. L Manzoli et al. Oral contraceptives and venous thromboembolism: a systematic review and meta-analysis. Drug Saf 2012; 35: 191.

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The FDA has approved the use of ulipristal acetate (ella – Watson) as an emergency contraceptive that can be taken up to 5 days after unprotected intercourse. It is available only by prescription.

The choice of which contraceptive to use may vary from one stage of reproductive life to another. Intrauterine devices (IUDs), progestin implants and sterilization are the most effective contraceptive methods available to women. Hormonal contraceptives, when used correctly, are also highly effective in preventing pregnancy. Barrier and fertility-based methods have the highest rate of failure.

Combination oral contraceptives increase the risk of venous thromboembolism (VTE). Their benefits, in addition to preventing pregnancy, include lowering the risk of ovarian and endometrial cancer, reducing dysfunctional uterine bleeding and increasing serum hemoglobin concentrations. Are these benefits worth the risk? And are some combination oral contraceptives safer than others?

The FDA has announced that it will lower the age for over-the-counter access to the emergency contraceptive Plan B1 from 18 to 17 years old. In a randomized, controlled trial, the two 0.75-mg levonorgestrel tablets in Plan B, taken 12 hours apart beginning within 72 hours after unprotected intercourse, decreased the overall pregnancy rate to 1.1% (11/976) of women who requested emergency contraception.2 The sooner the drug is taken after coitus, the more effective it is. Nausea and vomiting can occur with Plan B. Fetal malformations have not been associated with pregnancies that occurred despite use of levonorgestrel-only emergency contraception.3

1. Emergency contraception OTC. Med Lett Drugs Ther 2004; 46:10.
2. 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.
3. L Zhang et al. Pregnancy outcome after levonorgestrel-only emergency contraception failure: a prospective cohort study. Hum Reprod 2009 Mar 31 (epub).

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Transdermal, transvaginal and intrauterine hormone delivery systems have made highly effective contraceptive products more convenient to use. New oral contraceptive options include regimens with fewer or shorter hormone-free intervals.

In recent years, several new contraceptive options have become available in the United States. Novel hormone delivery systems such as transdermal, transvaginal and intrauterine devices have improved the convenience of highly effective contraceptive products. Like oral contraceptives and most barrier contraceptives, these devices do not protect against sexually transmitted diseases.

Seasonale (Barr), the first "extended-cycle" oral contraceptive, is now available in the US for pregnancy prevention. Active tablets containing 30 ╡g of ethinyl estradiol and 0.15 mg of levonorgestrel are taken for 84 consecutive days, followed by 7 days of inactive tablets, allowing for withdrawal bleeding only four times a year. Other combination oral contraceptives are dispensed as 21 days of active tablets and 7 days of placebo or no tablets, resulting in 13 withdrawal bleeding episodes each year.

An FDA Advisory Committee has recommended over-the-counter (OTC) marketing of Plan B (Barr), an emergency contraceptive "pill pack" that contains two 0.75-mg tablets of levonorgestrel to be taken 12 hours apart (Medical Letter 2000; 42:10). Plan B is one of two FDA-approved products for this indication. The Preven Emergency Contraceptive Kit (Medical Letter, 40:102, 1998) includes four tablets, each containing 0.25 mg of levonorgestrel and 50 ╡g of ethinyl estradiol; these are taken 2 at a time 12 hours apart (the "Yuzpe regimen") and are available only by prescription.

Many drugs can cause psychiatric symptoms, but a causal connection is often difficult to establish. Psychiatric symptoms that emerge during drug treatment may also be due to the underlying illness, previously unrecognized psychopathology, or psychosocial factors. The withdrawal of some drugs can cause symptoms such as anxiety, psychosis, delirium, agitation or depression.

An oral contraceptive (Yasmin - Berlex) containing 3 mg of drospirenone and 30 mcg of ethinyl estradiol is being promoted as having a low incidence of adverse effects.

The FDA had approved an intrauterine contraceptive device that releases the synthetic progestin levonorgestrel over a period of five years. The device has been available in Europe for 10 years.

Pantoprazole, the fourth benzimidazole proton pump inhibitor to become available in the United States, has been marketed for short-term oral treatment of erosive gastroesophageal reflux disease (GERD).

Two types of oral contraceptives are available in the USA: combination oral contraceptives that contain both an estrogen and a progestin, and progestin-only contraceptives, or "mini-pills."Used as directed, all oral contraceptives marketed in the USA are similarly effective in preventing pregnancy.

The FDA has approved marketing of Plan B (Women's Capital Corporation), an emergency contraceptive "pill pack"that contains two 0.75-mg tablets of levonorgestrel.

New information about contraceptives continues to become available. The commonly used methods of reversible contraception are listed below.

Desogen (Organon) and Ortho-Cept (Ortho), two oral contraceptives each containing a low dose (30 mcg) of the estrogen ethinyl estradiol plus 150 mcg of the progestin desogestrel, were recently approved by the US Food and Drug Administration for marketing in the USA. They are the first US oral contraceptives to contain desogestrel, which is widely used in oral contraceptive combination products in other countries. Desogestrel is one of three new progestins (norgestimate and gestodene are the others) considered less androgenic than previously available progestins (L Speroff et al, Obstet Gynecol, 81:1034, June 1993).

The commonly used methods of reversible contraception are listed in the table below. Additional information is available in RA Hatcher et al, Contraceptive Technology, 1990-1992, 15th ed, New York:Irvington, 1990.

The commonly used methods of reversible contraception are listed in the table. Additional information on the following pages and RA Hatcher et al, Contraceptive Technology, 1988-1989, 14th ed, New York:Irvington, 1988.