FDA Approves First Over the-Counter Birth Control Pill
The U.S. Food and Drug Administration (FDA) has approved the oral contraceptive Opill for sale over the counter, making it the first birth control pill in the United States that will be available without a prescription.
Opill, a progestin-only “mini-pill,” will be available without any age restrictions. People should be able to get it in stores and online starting early next year, drugmaker Perrigo said in a statement.
“This is huge,” says Dana Singiser, co-founder of the Contraceptive Access Initiative (CAI) and a board member of Planned Parenthood Metro Washington. “The FDA followed the evidence and the science to expand access to a pill that has been used safely and effectively by tens of millions if not hundreds of millions of women around the world for 50 years.”
New OTC Birth Control Pill Has a Long Track Record of Safety
Enabling people to buy Opill without seeing a doctor first is expected to broadly increase access to contraception and reduce unintended pregnancies, the FDA said in a statement. Almost half of the 6.1 million pregnancies in the United States each year are unintended, a circumstance that reduces the likelihood of prenatal care and increases the odds of preterm deliveries and other complications, the FDA said.
“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,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the statement.
Opill has been available with a prescription since 1973, the FDA said. Studies reviewed by the FDA prior to allowing over-the-counter sales found that most consumers understand how to properly use this drug without talking to a doctor or getting a prescription, the FDA said.
How Do You Take Opill and What Are the Side Effects?
To be effective, Opill should be taken at the same time every day, the FDA said. It shouldn’t be used by people with a history of breast cancer or anyone who is already using a different form of hormonal contraception including pills as well as contraceptive patches, vaginal rings, implants, injections, or intrauterine devices (IUDs).
The most common side effects of Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps, or bloating, the FDA said. People should see a doctor if they have repeated vaginal bleeding after sex, unusually long periods of bleeding, or if their monthly periods stop.
Users who miss two monthly periods, or anyone who misses a single monthly period after skipping some doses of Opill, should take a pregnancy test and discontinue Opill if the test is positive, the FDA said.
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Opill isn’t for emergency contraception and can’t prevent pregnancy after unprotected sex, the FDA also said. Like other oral contraceptives, this pill also doesn’t protect against transmission of HIV, AIDS, or other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis, the FDA said. Condoms should be used to prevent sexually transmitted diseases.
How Much Does Opill Cost and Where Can You Get It?
Perrigo hasn’t yet provided U.S. pricing information for Opill. “That will impact which women are able to access this as a contraceptive option,” says Asima Ahmad, MD, MPH, co-founder and chief medical officer of Carrot Fertility and a practicing reproductive endocrinologist and fertility specialist in Chicago.
Where Opill gets placed inside stores will also influence access, says Sarah Prager, MD, a professor of obstetrics, gynecology, and complex family planning at the University of Washington in Seattle and a fellow with the American College of Obstetricians and Gynecologists (ACOG).
If retailers decide to keep Opill behind the pharmacy counter, or under lock and key with other expensive items on store shelves, this may deter some people from asking for it and limit how much this option ultimately expands access, says Dr. Prager. “Anything that requires people to wait on line or makes the experience of getting contraception feel more stigmatizing may mean fewer people use it,” Prager says.
Underserved, High-Poverty, and Rural Communities Need Better Birth Control Options
The American Medical Association (AMA), long an advocate for over-the-counter contraceptive options, urged the FDA to make more hormonal birth control pills available without a prescription and advocated for keeping costs down.
“We must continue to remove barriers to affordable care for those in underserved, high-poverty, and rural communities,” AMA president Jesse Ehrenfeld, MD, MPH, said in an emailed statement. “We know barriers to oral contraceptives can lead to inconsistent or discontinued use. While it is important [that] patients maintain relationships with their physician to stay up to date on screenings, requiring an office visit to begin birth control is an unnecessary hurdle for patients who must take time off work, find childcare, and travel to appointments.”