First over-the-counter oral contraceptive approved by FDA

First over-the-counter oral contraceptive approved by FDA | Image Credit: © Postmodern Studio - © Postmodern Studio - stock.adobe.com.

Norgestrel (Opill; HRA Pharma) has become the first nonprescription daily oral contraceptive approved by the FDA for preventing pregnancy.

“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.”

There are 6.1 million pregnancies annually in the United States, of which about 50% are unintended. Adverse outcomes of unintended pregnancies include negative maternal and perinatal outcomes, such as increased preterm birth risk and decreased odds of receiving early prenatal care.

Individuals seeking contraception will be able to access norgestrel without consulting a health care provider, reducing barriers to contraception access. This may reduce the prevalence of unintended pregnancies and associated adverse outcomes.

In 1973, norgestrel received FDA approval for prescription use, highlighting its contraceptive efficacy. The manufacturer, HRA Pharma, later applied for norgestrel to become an over-the-countermethod of contraception. This required proof of safety and efficacy when used by consumers without support from a health care professional.

Research on norgestrel showed a significant percentage of consumers were capable of comprehending information on the Drug Facts label. Proper use of norgestrel is safe and effective, indicating it can be used as an over-the-counter product.

Efficacy of norgestrel is achieved when the product is used at the same time once daily, with efficacy decreasing if patients use medications that interact with norgestrel. Common side effects include dizziness, headaches, nausea, irregular bleeding, abdominal pain, cramps or bloating, and increased appetite.

Norgestrel is not effective as emergency contraception and should not be used in patients with breast cancer or breast cancer history. It also should not be used alongside other hormonal birth control products, and use should be discontinued if pregnancy has been confirmed.

HRA Pharma will determine the price and availability timeline of norgestrel. Consumers will be able to purchase the product at convenience stores, grocery stores, drug stores, and online.

Reference

FDA approves firstnonprescription daily oral contraceptive. July 13, 2023. Accessed July 13, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive