FDA Approves First Over-the-Counter Birth Control Pill

July 19, 2023

In 2023, the Food and Drug Administration (FDA) approved Opill, the first over-the-counter birth control pill. It will become the most effective non-prescription birth control method on the market. University Hospitals OB/GYN-in-chief Stephanie Teal, MD, MPH, says the newly approved pill has the potential to significantly expand access to contraception for women in the U.S.

“One of the biggest barriers to preventing unintended and undesired pregnancy is access to contraception. It requires making an appointment, getting an appointment in a timely fashion, and staying on top of your prescription so you don’t run out” say Dr. Teal. “This is going to make it so much easier for people who want to take the birth control pill.”

Dr. Teal says this development is a game-changer for women living in the U.S. The birth control pill is already available without a prescription in hundreds of other countries.

“It's a breakthrough because at this time more than ever, women are really looking to make sure that they have as much control of their fertility as they deserve and their family needs,” says Dr. Teal.

What is Opill and How Does it Work?

Opill (norgestrel) is a progestin-only pill, meaning it uses a version of the natural hormone progesterone to prevent pregnancy. Most women take combination pills, which contain both progestin and estrogen. Progestin-only oral contraceptive prevent conception by thickening the cervical mucus to stop sperm from penetrating and slowing down the egg’s progress through the fallopian tubes. It also suppresses ovulation in approximately half a woman’s cycles.

While combination birth control pills are safe, progestin-only pills are even safer, says Dr. Teal. Estrogen in birth control pills carries the risk of blood clots, heart attack, stroke and high blood pressure in susceptible women, but progesterone doesn’t have that effect. With the progestin-only pill, there is no increased risk of blood clots and no increased risk of cancer outside of certain hormone-sensitive cancers, says Dr. Teal.

The most common side effect with Opill is unscheduled or breakthrough bleeding. While this could be worrisome if you’re not expecting it, it is completely normal and does not affect the pill’s efficacy.

Effectiveness as a Contraceptive

Opill was first approved for prescription use 50 years ago, so the FDA cited the decades of safety and efficacy data to support making the pill available over the counter. When used as directed, Opill is 93 percent effective at preventing pregnancy. This is more effective than over-the-counter contraceptives such as condoms (87 percent effective) and spermicide (82 percent effective).

Other Medical Uses

Dr. Teal says the over-the-counter pill can also be effective for many women who take prescription birth control for hormone-sensitive medical conditions such as endometriosis, heavy menstrual bleeding and chronic pelvic pain. However, Dr. Teal notes that while the combined pill reliably suppresses ovulation in 95 percent of cycles, the progestin-only pill only suppresses ovulation about 50 – 60 percent of the time. This means the over-the-counter pill may not be effective at treating conditions in which ovulation suppression is important, such as menstrual migraines.

“So for people who've had success treating their medical conditions with the combined pill, I would absolutely recommend staying on what works for you,” says Dr. Teal.

New Pill Not for Everyone

Dr. Teal says that while the new over-the-counter birth control pill is safe and effective, it is not necessarily the best birth control method for everybody. Birth control pills in general are not as effective as other prescription contraceptive options such as IUDs, implants and injectables. Birth control pills may not be suitable for people who have trouble taking a pill every day since it needs to be taken daily to be effective.

Women who find occasional breakthrough bleeding or spotting bothersome may be happier with a different method. Women should speak with their healthcare provider if they have questions about different birth control options to help them decide which one is best for them.

But regardless of whether the over-the-counter pill is right for you, Dr. Teal says having another affordable, effective over-the-counter option for birth control is a welcome development: “The real benefit to this is the access and putting these really important personal decisions back into the hands of women.”