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No form of hormonal contraception has ever been available without a prescription in the United States; that is about to change, however. On July 13, 2023, the Food and Drug Administration (FDA) approved OPILL (norgestrel), a progestin-only birth control pill, as an over-the-counter oral contraceptive.[1] The FDA originally approved norgestrel as a prescription-only oral contraceptive in 1973.[2]
As of August 2023, it was not known what Opill will cost or when it will become available on...
No form of hormonal contraception has ever been available without a prescription in the United States; that is about to change, however. On July 13, 2023, the Food and Drug Administration (FDA) approved OPILL (norgestrel), a progestin-only birth control pill, as an over-the-counter oral contraceptive.[1] The FDA originally approved norgestrel as a prescription-only oral contraceptive in 1973.[2]
As of August 2023, it was not known what Opill will cost or when it will become available on store shelves. Once it does, though, consumers will be able to purchase it at drug stores, grocery stores and online without visiting a clinician or obtaining a prescription.
Making these pills available to consumers without requiring a clinician visit should widen access to contraception to those who are unable to attend regular medical appointments or who do not have health insurance. This is especially important because hormonal birth control methods (such as Opill) are generally more effective at preventing pregnancy than barrier methods (such as condoms),[3] which are currently the only birth control methods that can be purchased without a prescription. The availability of an over-the-counter oral contraceptive could help to reduce the unintended pregnancy rate in the United States (approximately 3 million pregnancies per year, or about half of all pregnancies).[4]
Like all oral contraceptives, Opill must be taken at the same time every day to be effective. Adverse effects for this drug include irregular bleeding, headaches, dizziness, nausea, abdominal pain, cramps and bloating.[5] Opill should never be taken concomitantly with another hormonal birth control product. It also cannot protect against sexually transmitted infections (STIs); to prevent STIs, use a male or female condom.
Importantly, patients who have (or have had) breast cancer should not take this medication; if you have had any other type of cancer, consult your clinician before starting Opill.[6]
If you decide to take Opill once it is on the market and you experience any adverse effects, be sure to report them to the FDA’s MedWatch adverse-event reporting program by visiting http://www.fda.gov/MedWatch or by calling 800-FDA-1088.
References
[1] Food and Drug Administration. FDA approves first nonprescription daily oral contraceptive. July 13, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive. Accessed August 30, 2023.
[2] Ibid.
[3] American College of Obstetricians and Gynecologists. Effectiveness of birth control methods. April 2023. https://www.acog.org/womens-health/infographics/effectiveness-of-birth-control-methods. Accessed August 30, 2023.
[4] Food and Drug Administration. FDA approves first nonprescription daily oral contraceptive. July 13, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive. Accessed August 30, 2023.
[5] Ibid.
[6] Ibid.
