Shannon Katz, PharmD, CentraCare St. Cloud
On July 13th, 2023, the FDA made history by approving the first over-the-counter (OTC) birth control pill in the US. From the manufacturer Perrigo, Opill® is the first non-prescription daily oral contraceptive to reach the OTC market and will join alongside other forms of OTC contraception such as spermicides, condoms, and diaphragms. According to an article published by the FDA regarding Opill’s® clinical research, when taken correctly, it is expected to be more effective than any other form of non-prescription contraceptive method. Specifically, 98% effective if taken consistently at the same time each day. This is because its chemical makeup of progestin needs to stay at a certain level within the body to reliably prevent pregnancy. Therefore, missing a dose or even taking the pill a few hours late renders the need for a backup form of contraception.
Opill® is composed of the active ingredient norgestrel, which is a hormone that belongs to the medication class known as progestins. This progestin component classifies Opill® as a progestin-only pill, or minipill, due to its absence of estrogen in the formulation. With this lack of estrogen, it does not carry the same contraindications as combination birth controls do. The key difference between estrogen-containing contraceptives and progestin-only contraceptives is that estrogen-containing contraceptives prevent ovulation from occurring, whereas the progestin only-contraceptives work to thicken cervical mucus to prevent sperm from fertilizing an egg. Because progestin-only contraceptives do not interfere with ovulation, the body may still experience periods of bleeding or spotting. Of note, side effects of Opill® can include irregular bleeding, headaches, dizziness, abdominal pain, cramps, or bloating. Populations who are instructed not to take Opill® include those who have breast cancer, have undiagnosed vaginal bleeding, are already pregnant, are actively using other birth control pills, and those who are male. There are currently no age restrictions to its use, however, it will only be effective for individuals who have started menstruating.
With 6.1 million pregnancies in the US each year, the FDA reports half are unintended. These unintended pregnancies frequently produce negative outcomes for both the mother and the growing baby such as emotional and financial stress, inadequate prenatal care, and potential health risks due to delayed or insufficient medical attention. With Opill® expanding accessibility to effective oral non-prescription birth control, reductions in the number of unplanned pregnancies and negative impacts can be expected to be seen in the future. Not only will it expand access, but it will also lessen the barriers associated with prescription birth control, such as the need to schedule an appointment with a healthcare provider or logistics in going to a pharmacy.
Opill® is expected to hit the market in early 2024. It will be available online and in retail stores. Perrigo has not announced pricing information but is expected to do so in the coming months.
References:
- Perrigo announces U.S. FDA approval for Opill® OTC daily oral contraceptive. Perrigo InvestorRoom. Accessed August 16, 2023. https://investor.perrigo.com/2023-07-13-Perrigo-Announces-U-S-FDA-Approval-for-Opill-R-OTC-Daily-Oral-Contraceptive
- Belluck P. F.D.A. approves first U.S. over-the-counter birth control pill. The New York Times. https://www.nytimes.com/2023/07/13/health/otc-birth-control-pill.html. Published July 13, 2023. Accessed August 16, 2023.
- FDA approves first nonprescription daily oral contraceptive/ FDA. Accessed August 16, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive
- Opill® [package insert]. Laboratoire HRA Pharma; 2017. Accessed August 16, 2023. label (fda.gov)
- Opill® Official Site – OTC daily birth control pill. Opill. Accessed August 16, 2023. https://opill.com/