(CNN) — The US Food and Drug Administration on Thursday approved the birth control pill Opill to be available over-the-counter — the first nonprescription birth control pill in the United States.
“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,” Dr. Patrizia Cavazzoni, the 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.”
Opill is a “mini-pill” that uses only the hormone progestin.
Its manufacturer, Perrigo, called the FDA action a “milestone” and a “giant leap for women’s empowerment ” in a statement. It said the company is committed to making the pill “accessible and affordable to women and people of all ages.”
“Today’s approval is a groundbreaking expansion for women’s health in the U.S., and a significant milestone towards addressing a key unmet need for contraceptive access,” said Frederique Welgryn, Perrigo global vice president for women’s health.
It’s not clear when Opill will be available over the counter at stores. The FDA says it’s up to Perrigo to determine the timeline and the medication’s price.
The FDA has faced pressure to allow Opill to go over-the-counter from lawmakers as well as health care providers.
In a statement Thursday, the agency addressed increasing reproductive access for women and adolescents.
“Nonprescription availability of Opill may reduce barriers to access by allowing individuals to obtain an oral contraceptive without the need to first see a health care provider. Almost half of the 6.1 million pregnancies in the U.S. each year are unintended. 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,” the FDA said in the statement.
A recent study showed that it’s become harder for women to access reproductive health care services more broadly – such as routine screenings and birth control – in recent years.
About 45% of women experienced at least one barrier to reproductive health care services in 2021, up 10% from 2017. Nearly 19% reported at least three barriers in 2021, up from 16% in 2017.
A group of advisers to the FDA recommended in May that Opill be approved for over-the-counter use.
The pill needs to be taken at the same time everyday in order to be effective.
The medication should not be taken by anyone who has, or previously had, breast cancer, the FDA says.
Some side effects commonly experienced while on Opill are “irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating,” according to the FDA.
CNN’s Meg Tirrell contributed to this report.
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