KUALA LUMPUR, July 14 – The United States’ Food and Drug Administration (FDA) yesterday approved the Opill (norgestrel) tablet for nonprescription use to prevent pregnancy, making it the first daily oral contraceptive approved for use in the US without a prescription.
Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online.
Progestin is a type of progesterone, a hormone that plays a role in the menstrual cycle and pregnancy.
In May 2023, the FDA’s Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee (ORUDAC) voted unanimously 17 to 0, with no abstentions, that the benefits of making Opill available for over-the-counter (OTC) use, outweigh the risks, said its manufacturer Perrigo, a pharmaceutical company based in Dublin.
The contraceptive efficacy of Opill, which consists of 0.075 mg of the hormone norgestrel, was established with the original approval for prescription use in 1973.
“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, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
“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.”
Almost half of the 6.1 million pregnancies in the US each year are unintended, according to the FDA.
Unintended pregnancies have been linked to negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental and child health outcomes.
Availability of nonprescription Opill may help reduce the number of unintended pregnancies and their potential negative impacts.
According to a US study, one-third of adult US women who have ever tried to obtain prescription contraception reported access barriers.
Last year, Perrigo, through its subsidiary HRA Pharma, applied to switch norgestrel from a prescription to an OTC product.
For approval of a product for use in the nonprescription setting, the FDA requires that the applicant demonstrate that the product can be used by consumers safely and effectively, relying only on the nonprescription drug labelling without any assistance from a health care professional.
According to the FDA, studies showed that consumer understanding of information on the Opill Drug Facts label was high overall and that a high proportion of consumers understood the label instructions, supporting their ability to properly use the drug when it is available as an OTC product.
“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,” said Frederique Welgryn, Perrigo global vice president for Women’s Health, 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.”
The announcement comes on the heels of an Executive Order issued last month by US president Joe Biden on Strengthening Access to Affordable, High-Quality Contraception and Family Planning Services.
The Executive Order directs the Secretaries of the Treasury, Labor, and the Department of Health and Human Services to consider new actions to improve access to affordable OTC contraception, including emergency contraception.
The most common side effects of Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating.
Consumers should inform a health care provider if they develop repeated vaginal bleeding after sex, or prolonged episodes of bleeding or amenorrhea (absence of menstrual period), the FDA advised.
Opill should also not be used by those who have or have ever had breast cancer. Consumers who have any other form of cancer should ask a doctor before use, the FDA cautioned.
According to its manufacturer, Opill will be available in store and online at leading retailers across the US early in the first quarter of 2024.