First Over-the-Counter Birth Control Pill Receives FDA Approval

The oral contraceptive Opill is the first birth control pill to be sold over-the-counter in the United States after receiving approval from the Food and Drug Administration (FDA).

Without any age limits, Opill, a progestin-only “mini-pill,” will be offered. Drugmaker Perrigo said in a statement that customers should be able to purchase it in stores and online as early as next year.

The Contraceptive Access Initiative (CAI) co-founder and board member of Planned Parenthood Metro Washington, Dana Singiser, calls this a monumental achievement. The FDA expanded access to a pill that has been taken safely and effectively by tens of millions, if not hundreds of millions, of women worldwide for 50 years by doing so in accordance with the data and science.

A New OTC Birth Control Pill Has a Proven Safety Record

The FDA stated in a statement that allowing consumers to purchase Opill without first visiting a doctor is anticipated to significantly expand access to contraception and reduce unwanted pregnancies. The FDA reported that nearly half of the 6.1 million pregnancies in the US each year are unplanned, which lowers the likelihood of prenatal care and raises the risk of preterm births and other issues.

“When used as directed, daily oral contraception is safe and expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy,” said Patrizia Cavazzoni, MD, the director of the FDA’s Center for Drug Evaluation and Research.

According to the FDA, Opill has been accessible with a prescription since 1973. According to studies the FDA looked at before approving over-the-counter sales, the majority of consumers are aware of how to use this medication safely without consulting a doctor or obtaining a prescription.

What Are the Side Effects of Opill and How Do You Take Them?

The FDA advised taking Opill at the same time each day for maximum effectiveness. Anyone who has previously used a hormonal type of birth control, such as tablets, patches, vaginal rings, implants, injections, or intrauterine devices (IUDs), or who has a history of breast cancer shouldn’t take it.

According to the FDA, irregular bleeding, headaches, dizziness, nausea, increased hunger, abdominal pain, cramps, or bloating are some of the most frequent side effects of Opill. If someone experiences recurring vaginal bleeding after intercourse, particularly protracted bleeding periods, or if their menstrual cycle stops, they should consult a doctor.

The FDA advised users to perform a pregnancy test and stop using Opill if the results are positive if they have missed two consecutive monthly periods, or if they have missed one monthly period after skipping some doses of Opill.

The FDA further said that Opill is not intended for emergency contraception and cannot stop pregnancy following unprotected sex. According to the FDA, this pill, like other oral contraceptives, doesn’t shield users against the spread of HIV, AIDS, or other sexually transmitted diseases like chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. To avoid sexually transmitted infections, use condoms.

How Much Does Opill Cost and Where Can You Get It?

For Opill, Perrigo has not yet disclosed U.S. pricing data. Asima Ahmad, MD, MPH, co-founder and chief medical officer of Carrot Fertility and a practicing reproductive endocrinologist and fertility specialist in Chicago, says that will affect which women are able to utilize this as a contraceptive option.

According to Sarah Prager, MD, a professor of obstetrics, gynecology, and complex family planning at the University of Washington in Seattle and a fellow of the American College of Obstetricians and Gynecologists (ACOG), where Opill is put inside of stores will also have an impact on access.

According to Dr. Prager, some customers may be discouraged from asking for Opill if stores choose to keep it behind the pharmacy counter or locked up with other pricey things on store shelves. This will likely limit how much access this choice finally expands. According to Prager, “anything that makes getting contraception feel more stigmatizing or makes people wait in line may result in fewer people using it.”

Rural, Underserved, and High-Poverty Communities Require Better Birth Control Options

The American Medical Association (AMA), which has historically supported over-the-counter contraceptive choices, requested the FDA to expand the number of hormonal birth control pills that are available without a prescription while also arguing for cost-effectiveness.

According to AMA President Jesse Ehrenfeld, MD, MPH, “We must continue to remove barriers to accessible, affordable care for those in underserved, high-poverty, and rural communities.” “We are aware that obstacles to using oral contraceptives can result in inconsistent or ceased use. While it’s crucial for patients to be in touch with their doctors to stay on top of screenings, making the first step in birth control a doctor visit is an unneeded barrier for those who already have to take time off work, arrange childcare, and travel to appointments.