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Friday, July 12, 2024

The US Finally Approved an Over-the-Counter Birth Control Pill. Here’s What to Know

Birth control pills will soon be available in US pharmacies without a doctor’s prescription. Last week, the US Food and Drug Administration made the historic decision to approve the nation’s first over-the-counter birth control pill—something that’s already allowed in more than 100 countries.

Health experts say the move will give people more options for effective birth control and could reduce unintended pregnancies. “It's a huge step for people to access birth control more easily in the US,” says Jessica Lee, an obstetrician-gynecologist at the University of Maryland Medical Center and an assistant professor at the University of Maryland School of Medicine.

She says an over-the-counter pill could benefit teens and young adults who are uninsured or on their parents’ plan, as well as people who have trouble accessing the healthcare system for financial or residency reasons, such as lack of insurance or not having a regular doctor.

It could also be a boon for people who have these things but simply run out of a prescription before they can see their doctor. A 2021 survey conducted by the Kaiser Family Foundation found that one third of oral contraceptive users missed doses because they were not able to get their next supply in time. “This could really help be a bridge between prescriptions in case they're just not able to access birth control for a month or two,” says Lee.

“There's a clear public health need for expanding access to contraception,” says Victoria Nichols, who leads Free the Pill, a coalition of organizations that supports over-the-counter birth control pills. “The requirement to get a prescription creates lots of barriers for people who want to get birth control pills.”

Called Opill, it will be available in major pharmacies in early 2024 with no age requirement for obtaining it, according to manufacturer Perrigo Company. The over-the-counter designation only applies to Opill, not other brands of contraceptive pills, or Plan B or abortion pills.

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Perrigo has yet to announce the cost of a monthly pill pack, but Frédérique Welgryn, the company’s global vice president for women’s health, said in a press briefing last week that the company is committed to making Opill “affordable and accessible” to those who need it. She added that Perrigo plans to launch a patient assistance program to “help women and people who would benefit from using Opill but are struggling to make ends meet.” Lee says $20 or less a month would be ideal, especially for younger or low-income people, groups that are more likely to have unintended pregnancies.

Like other oral contraceptives, Opill is taken daily. It contains only progestin, a synthetic version of the hormone progesterone, and prevents pregnancy by thickening the cervical mucus, which stops sperm from entering the uterus and fertilizing an egg. It must be taken at the same time each day without breaks between monthly packs. If users miss or delay a dose for more than three hours, back-up birth control, like condoms, should be used.

Early clinical trials of norgestrel, the active ingredient in Opill, have shown that the pills can be up to 98 percent effective at preventing pregnancy, but only when the drug is taken exactly as indicated and used along with a back-up form of birth control. In real life, effectiveness is usually lower.

Doctors in the US more commonly prescribe birth control pills that contain both progestin and a synthetic form of estrogen. These combination pills thicken the mucus of the cervix while also preventing the ovaries from releasing an egg each month. The added estrogen in combination pills provides a bit more leeway for missing a dose, Lee says.

Still, Anne-Marie Amies Oelschlager, a professor of obstetrics and gynecology at the University of Washington School of Medicine, says Opill is likely more effective than other options like condoms or using the withdrawal method. For young people, who are more likely to experience contraception failure, she recommends using a barrier method like condoms in addition to Opill—which decreases the risk of pregnancy as well as sexually transmitted infections. “I'm a big fan of dual use for people who are not in a monogamous relationship and not intending to get pregnant anytime soon,” she says.

While an over-the-counter option is new, progestin-only pills aren’t. Norgestrel was first approved as a prescription drug by the FDA in 1973 under the brand name Ovrette. In 2005, its manufacturer stopped selling the drug for business reasons. Other progestin-only pills are available by prescription in the US under brand names like Camila, Errin, and Jolivette.

“There are a lot of reasons why we prescribe progestin-only pills rather than combined oral contraceptive pills,” Amies Oelschlager says. Estrogen increases blood clotting, so patients with a history of blood clots, stroke, heart attack, and high blood pressure should avoid combination pills. Estrogen also isn’t recommended for smokers over the age of 35, patients who have recently been pregnant, and those who have migraine with aura.

Progestin-only pills are safe for most people who could get pregnant, according to Perrigo, although people who have or previously had breast cancer shouldn’t take Opill, since some cancers can grow in response to progesterone. The company lists the most common side effects of Opill as irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps, and bloating. In a trial that enrolled 2,575 participants, 17 percent (or 379 people) discontinued Opill due to side effects—the most common of which was uterine bleeding.

While these side effects happen, they are typically minor and not life-threatening. “This medication is extremely safe,” Amies Oelschlager says. “But people have to be pretty compulsive to take it at the same time every day.”

With a long track record of safety since the first birth control pill was approved in 1960, Lee hopes more oral contraceptives will become available over-the-counter in the near future. “I'd be thrilled to see a combined oral contraceptive on the market,” she says. “I think having this progestin-only pill is the path to paving the way for that.”

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