The Food and Drug Administration on Thursday approved the first daily birth control pill for sale without a prescription.
Perrigo’s progestin-only contraceptive, Opill, will be available over the counter beginning in the first quarter of 2024, company officials said.
“Today marks a truly momentous day for women’s health nationwide,” Perrigo president and CEO Patrick Lockwood-Taylor said Thursday in a statement, adding that Opill “has the potential to radically transform women’s access to contraception.”
Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said the pill will be available to millions of people nationwide.
“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,” she said.
Almost half of the 6.1 million pregnancies nationwide each year are unintended, according to the FDA. A 2011 survey found that nearly a third of women who tried to get prescription contraceptives reported having a hard time doing so.
“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,” officials said. “Availability of nonprescription Opill may help reduce the number of unintended pregnancies and their potential negative impacts.”
Perrigo asked regulators last year to make Opill available over the counter. The pill was first approved by the FDA in 1973 for prescription use in the U.S. On Thursday, Perrigo’s global vice president for women’s health, Frederique Welgryn, called the nonprescription approval “a groundbreaking expansion for women’s health in the U.S., and a significant milestone towards addressing a key unmet need for contraceptive access.”
The approval came two months after the FDA’s Nonprescription Drugs Advisory Committee and its Reproductive and Urologic Drugs Advisory Committee unanimously recommended selling Opill over the counter, determining that the benefits offered by the pill outweighed the risks.
Side effects of Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating. Regulators noted that people who have or have had breast cancer should not use Opill.
©2023 Cox Media Group
