The Food and Drug Administration on Thursday approved the first daily birth control pill that does not require a prescription.
The over-the-counter birth control pill is a progestin-only pill called Opill that is produced by French drugmaker HRA Pharma.
“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, director of the FDA’s Center for Drug Evaluation and Research, said Thursday 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,” Cavazzoni said.
Opill is expected to become available sometime early next year at convenience stores, grocery stores, and for sale online. Opill was approved decades ago by the FDA, but up until now patients needed a prescription to get it.
In May, an independent FDA advisory panel voted unanimously to dub the over-the-counter birth control drug safe for most people.
Opill uses only progestin, a synthetic hormone that mimics progesterone, but other birth control pills use both estrogen and progestin, which work to stop ovulation. The progestin-only pill, sometimes called the “minipill,” does not always stop ovulation.
About two thirds of adult American women under 50 use some kind of contraception, and a third of those women use birth control pills, according to a 2022 Kaiser Family Foundation survey.
However, over the last few years some women have spoken out about how they feel hormonal birth control damaged their health, particularly the kind that includes estrogen as well. Women have reported depression, anxiety, mood swings, and even their hair falling out as a result of hormonal birth control.
A 2016 Danish study found that hormonal birth control was associated with depression, especially among teenagers.
Some OB-GYNs have even said they refuse to prescribe hormonal birth control because it comes with too many health risks.
However, some doctors say the progestin-only pill comes with fewer risks, even though it still disrupts a woman’s natural hormone cycle with synthetic hormones.
The FDA advisers raised concerns about people, especially young teenagers, being able to pick up their birth control pills as easily as if they were picking up ibuprofen. In the end though, the FDA advisory panel decided the benefits of avoiding unwanted pregnancies outweighed the risks.
In its announcement Thursday, the FDA said the most common side effects of Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps, and bloating.
The FDA said making the pill available without a prescription may help reduce the number of unintended pregnancies and their “potential negative impacts,” noting that the U.S. has 6.1 million unintended pregnancies per year.
“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,” the FDA said.
Opill should be taken at the same time every day to make sure it is effective, the FDA said.