First Over-the-Counter Birth Control Pill Gets FDA Approval

The Food and Drug Administration (FDA) has approved Opill^®, a progestin-only daily oral contraceptive, for over-the-counter (OTC) use.

Opill contains norgestrel, a single active steroid ingredient. The contraceptive works by thickening the cervical mucus which helps to inhibit sperm penetration. Opill is effective from 48 hours after initiating treatment, so individuals are advised to use a barrier method during the first 2 days. 

The approval was based on data from the OTC development program which included several label comprehension studies that demonstrated Opill can be used by consumers safely and effectively. In May 2023, the FDA’s Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee voted 17 to 0, with no abstentions, that the benefits of making Opill for OTC use outweigh the risks. 

Opill should not be used by individuals with known or suspected breast cancer, or those with known or suspected pregnancy. It should also not be used with another birth control pill, vaginal ring, patch, implant, injection, intrauterine device, or as an emergency contraceptive.

The most common adverse reactions reported with Opill use were irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps and bloating.

Opill is supplied as a tablet containing 0.075mg of norgestrel in 28-count packs. The product is expected to be available in retail stores and online early in the first quarter of 2024.

“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.”

Medical organizations, such as the American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians have all expressed support of OTC access for oral hormonal contraceptives.