Silver Spring, MD—Look for the newly approved OTC birth control pill, Opill, to be available to pharmacies in the first quarter of next year, the product’s manufacturer advised. In mid-July, the FDA approved norgestrel tablet for nonprescription use to prevent pregnancy; it is the first daily oral contraceptive approved for use in the United States without a prescription.

“Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online,” according to the FDA.

The agency noted that the timeline for availability and price of the nonprescription product is determined by the manufacturer, but other approved formulations and dosages of other oral contraceptives would remain available by prescription only.

“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”

The FDA advised that nonprescription availability of Opill is expected to reduce barriers to access by allowing women to obtain an oral contraceptive without the need to first see a healthcare provider. It also might reduce the number of unintended pregnancies and their potential negative impacts, according to the agency, which pointed out that nearly one-half of the 6.1 million pregnancies in the U.S. each year are unintended. Unintended pregnancies have a reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental, and child health outcomes.

According to approval documents for Opill, the contraceptive efficacy of norgestrel was established with the original approval for prescription use in 1973. HRA Pharma applied to switch norgestrel from a prescription to an OTC product. The approval was based on studies showing that consumer understanding of information on the Opill Drug Facts label was high overall and that most consumers understood the label instructions.

HRA Pharma was acquired by Perrigo Company, PLC, which noted in a press release, “Nearly 50 years of use and scientific evidence demonstrate that progestin-only pills such as Opill are effective at preventing pregnancy and are safe for most women to use. OTC oral contraception has support from major medical organizations including the American College of Obstetricians and Gynecologists, the American Medical Association, the Society for Adolescent Health and Medicine and the American Academy of Family Physicians.”

The FDA approval indicated that Opill should be taken at the same time every day and that adherence to daily use at the same time of day is important for the pill’s effectiveness. It also pointed out that the use of medications that interact with Opill can result in decreased efficacy of Opill or the other medication, or both, potentially resulting in unintended pregnancy.

Irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps, or bloating are listed as the most common side effects.

The FDA cautioned that Opill should not be used by those who have or have ever had breast cancer and that women who have any other form of cancer should ask a doctor before use. Opill also should not be used together with additional hormonal birth control product, such as another oral contraceptive tablet, a vaginal ring, a contraceptive patch, a contraceptive implant, a contraceptive injection, or an intrauterine device.

Pharmacists should advise purchasers that the use of Opill might be associated with changes in vaginal bleeding patterns, such as irregular spotting and prolonged bleeding. Women should inform a healthcare provider if they develop repeated vaginal bleeding after sex or prolonged episodes of bleeding or amenorrhea. Pregnancy tests are recommended for those who miss two periods (or have missed a single period and have missed doses of Opill) or suspect they may be pregnant; Opill should be discontinued if pregnancy is confirmed.

The approval also emphasized that Opill is not for use as emergency contraception and does not prevent pregnancy after unprotected sex. Oral contraceptives also do not protect against transmission of HIV, AIDS, and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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