The AAP is applauding the Food and Drug Administration’s (FDA’s) approval of the first nonprescription birth control pill and is calling for the oral contraceptive to be affordable for patients.
“Making birth control available over-the-counter will help reduce barriers and provide adolescents with another option for accessing evidence-based contraception,” AAP President Sandy L. Chung, M.D., FAAP, said in a statement. She said pediatricians are available to answer patients’ questions and provide guidance on contraception options.
The FDA’s approval applies to the progestin-only birth control pill Opill (norgestrel) from Perrigo Co. affiliate HRA Pharma. It will be available over the counter at drugstores, convenience stores, grocery stores and online in the first quarter of 2024, according to the manufacturer. The approval comes as data show about 3 million pregnancies in the U.S. each year are unintended.
“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, M.D., director of the FDA's Center for Drug Evaluation and Research, said in a press release. “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 daily birth control pill that consists of 0.075 milligrams of norgestrel and was first approved by the FDA in 1973. At the time, data showed the likelihood of becoming pregnant in the first year of prescription use was about 2%. Since then, 17 million packs have been sold in the U.S.
In May, a panel of FDA advisers voted 17-0 in favor of allowing nonprescription use of Opill after a day and a half of presentations and discussions. While the FDA staff expressed reservations about some women using the medication correctly, the advisers said the benefits of increasing access to safe, effective contraception would outweigh the risks.
In its decision memo released Thursday, the FDA agreed with the risk-benefit assessment, citing the medical, economic and social harms of unintended pregnancy.
Opill must be taken at the same time every day to be effective. The most common side effects are irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps and bloating, according to the FDA. People should talk to a doctor if they have repeated vaginal bleeding after sex, prolonged episodes of bleeding or absence of a menstrual period.
Opill should not be taken by people who have ever had breast cancer, are/may be pregnant, are taking other hormonal birth control or who need emergency contraception. It does not protect against sexually transmitted infections, so the FDA recommends also using barrier methods such as condoms.
Resources
- Frequently asked questions about Opill
- FDA decision memo on Opill
- Information from the AAP on equitable access to sexual and reproductive health care
- Information from the CDC on progestin-only birth control pills
- Information from the CDC on teen pregnancy
- Information for parents from HealthyChildren.org on contraception options for teens
