FDA Approves First Over-The-Counter, Nonprescription Daily Oral Contraceptive

The FDA has approved the first nonprescription, progestin-only daily oral contraceptive—norgestrel—for the prevention of pregnancy.

“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,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release.

The timeline for the availability of norgestrel and its price of the product will be determined by the manufacturer.

The switch from prescription use to nonprescription use required the applicant to show that the “product can be used by consumers safely and effectively, relying only on the nonprescription drug labeling without any assistance from a health care professional.” Studies were able to establish that consumers had a high understanding of information on the product’s Drug Facts label. Further, a high proportion of consumers understood the label instructions, which supported their ability to use norgestrel.

According to the press release, norgestrel should be taken at the same time every day to ensure its effectiveness. Using medications that interact with norgestrel may result in a decrease in its efficacy.

The most common adverse events include irregular menstrual bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating. Further, nogestrel may cause irregular vaginal spotting and prolonged bleeding. Consumer should inform their health care provider if they develop repeated vaginal bleeding after sex, or prolonged episodes of bleeding or amenorrhea.

Norgestrel is not an emergency contraception and does not prevent pregnancy after unprotected sex. Similar to other contraceptives, norgestrel does not protect again sexually transmitted infections and diseases.

Reference:

FDA approves first nonprescription daily oral contraceptive. News release. The US Food and Drug Administration; July 13, 2023. Accessed July 21, 2023. www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive