Progestin-only pill eyed as OTC OC candidate

With relatively few contraindications to use, progestin-only pills might be a possible candidate for over-the-counter (OTC) use in the United States. But what will it take to move progestin-only pills to the drugstore shelves?

New research underscores the low prevalence of contraindications to progestin-only pills.1 Researchers looked at data from two studies, the Self-Screening Study (a sample of reproductive-aged women in the general population in El Paso, TX) and the Prospective Study of OC Users (a sample of current oral contraceptive [OC] users who obtain pills in El Paso clinics or over the counter in Mexican pharmacies). Researchers found just 1.6% of women from the general population and 0.6% of current users in El Paso had at least one contraindication to progestin-only pills. This finding contrasts with the prevalence of contraindications to combined oral contraceptives, which has been reported to be as high as 39%.2

If progestin-only pills were available over the counter, they could improve women's access to contraception and better enable women to prevent unwanted pregnancies, says Kari White, PhD, assistant professor in the University of Alabama at Birmingham School of Public Health. In addition, this move would provide women with an OTC contraceptive option that is more effective than methods currently available, such as condoms and spermicides, says White, who served as lead author of the current research.

Although there tend to be a perception that progestin-only pills are less effective than combined pills, there are formulations registered in Europe that contain desogestrel that have been found to be quite effective at preventing ovulation and pregnancy and are very popular, says White. With Cerazette, a 75 mcg desogestrel pill marketed internationally by Merck, ovulation inhibition is maintained after 12-hour delays in tablet intake, with return of ovulation taking at least seven days.3 While the pill is available in several international countries, it is not available in the United States.

One-fifth of (20.25%) of CTU readers who participated in the 2011 Contraception Survey say they support over-the-counter availability of progestin-only contraceptives. About 23% said they support pharmacy access to oral contraceptives when a pharmacist can screen for contraindications. About 25% said they did not support OTC access.

More research needed

What are the next research steps in bringing a potential OTC product to the U.S. market? With support from the Society of Family Planning, the Oral Contraceptives Over-the-Counter Working Group recently completed a nationally representative survey of women of reproductive age on their opinions about OTC access to OCs and their interest in using the pill if it were available OTC, says Dan Grossman, MD, a member of the Working Group and senior associate at Ibis Reproductive Health in Oakland, CA. The Working Group is a coalition of reproductive health rights and justice organizations, nonprofit research and advocacy groups, university-based researchers, and clinicians who are advocating for a safe, effective OTC pill.

"We are completing the analysis of that now, and we hope to submit for publication in the next month," says Grossman. "Other research that will be needed is a label comprehension study and an actual use study of a potential OTC product."

Move past hurdles

Reproductive health advocates have been on the move since the recent December 2011 rejection of full OTC status for the emergency contraceptive Plan B One Step by Health and Human Services Secretary Kathleen Sibelius. How did the rejection impact plans, if any, for possible development of an OTC OC? (Read more about the move; see "OTC access to EC blocked — What's next?" February 2012, p. 15.)

"Secretary Sibelius' decision to overrule the recommendation of the Food and Drug Administration (FDA) is certainly outrageous and very disappointing," says Grossman. "Until this has been resolved, it seems unlikely that an OTC application for an OC product would be approved without a similar age restriction."

The New York City-based Center for Reproductive Rights in February 2012 asked the federal court to reopen the center's 2005 lawsuit against the FDA for imposing unnecessary age restrictions on emergency contraception. The center also requested the addition of Sebelius as a defendant in the reopened case for her role in overruling the FDA's decision to approve Plan B One-Step for over-the-counter status in December 2011.

"We remain hopeful that the evidence-based recommendation of the FDA regarding Plan B One-Step will eventually prevail," says Grossman. "But in the meantime, we are continuing with our efforts."

References

  1. White K, Potter JE, Hopkins K, et al. Contraindications to progestin-only oral contraceptive pills among reproductive-aged women. Contraception 2012. Doi:10.1016/j.contraception.2012.01.008.
  2. Grossman D, Fernandez L, Hopkins K, et al. Accuracy of self-screening for contraindications to combined oral contraceptive use. Obstet Gynecol 2008; 112:572-578.
  3. Korver T, Klipping C, Heger-Mahn D, et al. Maintenance of ovulation inhibition with the 75-microg desogestrel-only contraceptive pill (Cerazette) after scheduled 12-h delays in tablet intake. Contraception 2005; 71:8-13.