FDA Approves First Nonprescription Daily Oral Contraceptive Norgestrel

Editor's note: This article originally appeared on ContemporaryOBGYN.net

Norgestrel (Opill; HRA Pharma) gained approval as the first nonprescription daily oral contraceptive by the US Food and Drug Administration (FDA) for preventing pregnancy.¹

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

There are 6.1 million pregnancies annually in the US, 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.

"Of all the developed nations in the world, the US has the highest maternal mortality rate," Michael Aziz MD, MPH, maternal-fetal medicine specialist and member of the State Liaison Network for the Society for Maternal-Fetal Medicine (SMFM) explained in an interview with HCPLive. "That's only gone up with the current COVID-19 pandemic."²

Still, before the pandemic, the dangers of pregnancy were rising, showing disproportionate disparities. Minority maternal mortality rates are much higher than those observed in Caucasians. In addition to this, pregnancy can bring about potentially fatal obstacles for those with chronic conditions.³

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-counter method of contraception. This required proof of safety and efficacy when used by consumers without support from a healthcare professional.¹

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.

"Today's approval is a groundbreaking expansion for women's health in the US, and a significant milestone towards addressing a key unmet need for contraceptive access," Frederique Welgryn, Perrigo Global Vice President for Women's Health said in a statement. "Perrigo is committed to making Opill, which is now the most effective method available OTC at preventing pregnancy, accessible and affordable to women and people of all ages.”⁴

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.¹

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.

References:

1. 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
2. Grossi G. Michael Aziz, MD: Abortion Reduces Risk of Death. HCPLive. June 24, 2022. https://www.hcplive.com/view/michael-aziz-md-abortion-reduces-risk-of-death
3. Grossi G. Maternal Mortality Rates Highlight Alarming Inequities by State, Race/Ethnicity. HCPLive. July 3, 2023. https://www.hcplive.com/view/maternal-mortality-rates-alarming-inequities-state-race-ethnicity
4. Perrigo Announces U.S. FDA Approval for Opill® OTC Daily Oral Contraceptive. News Release. July 13, 2023. https://investor.perrigo.com/2023-07-13-Perrigo-Announces-U-S-FDA-Approval-for-Opill-R-OTC-Daily-Oral-Contraceptive