The FDA Just Approved a Game-Changing OTC Birth Control Pill — Should You Switch to It?

Reproductive health is trapped in a veritable hellscape. Roe v. Wade, the Supreme Court’s landmark 1973 decision guaranteeing the right to abortion, was overturned by the same institution last May. Over the following year, many states issued abortion bans with either no or narrow exceptions. They’ve also gone after drugs like mifepristone and misoprostol for their use in medical abortion.

Now, in a momentous decision on Thursday, the U.S. Food and Drug Administration (FDA) approved the first over-the-counter hormonal birth control called Opill for purchase without prescription or age restriction. The decision follows two FDA advisory panels in May; the panels voted unanimously in favor of approval.

It’s a grassroots effort that’s been years, if not decades, in the making, Alison Edelman, division director of Complex Family Planning at Oregon Health and Science University, tells Inverse. A watershed moment in the history of reproductive rights, the Opill is expected to dismantle several different barriers preventing individuals and often medically underserved communities from ready and quick access to birth control. This comes especially at a time when unintended pregnancies account for around half of all pregnancies in the US.

So how exactly does the Opill work, and is it safe? Here’s what you need to know.

What is the Opill?

It’s a hormonal birth control pill first approved under the name norgestrel by the Food and Drug Administration in 1973 on a prescription-only basis. Perrigo, a drug company based in Dublin, Ireland, acquired the rights to the drug last year when it bought Paris-based HRA Pharma. HRA Pharma had previously acquired the pill from Pfizer in 2014. Currently, the pill is not being marketed in the US but is available without a prescription in the UK as of 2021.

Unlike combination birth control containing synthetic forms of estrogen and progesterone — the two primary sex hormones that play essential roles in the menstrual cycle and reproductive system — the Opill, also known as the “mini-pill,” contains progestin only. Progestin is the synthetic form of progesterone, Carrie Sopata, an associate professor of obstetrics and gynecology at the University of Virginia Health, tells Inverse.

Estrogen in hormonal birth control typically helps to control menstrual bleeding while progestin is the heavy hitter preventing pregnancy by essentially creating a sperm roadblock, thickening mucus in the cervix (the “neck” of the uterus connecting it to the vagina). This mechanism is similar to how hormonal intrauterine devices like the Mirena work.

But you need more than a mucusy roadblock to stop pregnancy — you need to slam the brakes on ovulation, which is when a mature egg is released from the ovaries. Progestin-only pills can do that but not consistently at low doses. According to the American College of Obstetricians and Gynecologists, about four in 10 women who use these hormonal contraceptives will continue to ovulate, although they won’t necessarily get pregnant. With perfect use of taking the pills at the same time every day, fewer than one in 100 women get pregnant during their first year on progestin-only pills.

The Opill contains a low dose of progestin at 0.075 milligrams per pill (the pill pack is for 28 days) and has to be taken at the same time every day, says Edelman of OHSU. The contraceptive is considered broadly effective against pregnancy, thickening cervical mucus and stopping ovulation in a majority of individuals taking it, according to data provided to the FDA by HRA Pharma.

Edelman says the biggest impact on Opill’s effectiveness is how well a person adheres to taking it consistently every day. But there are other pre-existing conditions that may affect the drug’s efficacy, like if someone has issues with malabsorption — where the body is unable to properly absorb and utilize nutrients from the food consumed — or is obese.

“There are certain types of bariatric surgery that make it more difficult to absorb drugs, so there is some concern with that group,” says Edelman.

Previous studies looking into how well combination birth control works for higher-weight individuals had shown that blood hormone levels were a bit on the lower side compared to normal-weight counterparts. However, this doesn’t seem to be the case for the Opill, according to Edelman. In a study Edelman and her colleagues at OHSU conducted on behalf of HRA Pharma, they found missing a single dose or taking a dose late still provided effective contraception for individuals with and without obesity.

“We know that with continuous dosing like with progestin-only pills, that actually improves outcomes in both higher weight individuals and individuals at any weight,” says Edelman.

Will it be safe to use? Are there any side effects?

Progestin-only birth control like the Opill, on the whole, is much safer than combination contraceptives, say Edelman and Sopata.

“The risks associated with combined oral contraceptives are attributed to estrogen, [such as] increasing your risk for blood clots,” explains Sopata, adding that the safety profile of progestin-only pills has been well-documented in the decades since this type of birth control has been around.

“[The Opill] is way safer than many of the medications we have over the counter currently,” says Edelman. “Tylenol is one of the biggest medications we have difficulties of people overdosing on. With the Opill, you can take several packages — which I’m not recommending — and while you might not feel good, it’s not going to create a toxic situation.”

There are side effects with progestin-only birth control. Again, they’re minimal compared to combined hormonal birth control. These may include changes to your menstrual flow, bleeding in-between periods, acne, mood changes, and headaches, among others. Depending on family or personal medical history, certain folks might not be able to take the Opill, say Edelman and Sopata. For instance, there are some breast cancers that are sensitive to progesterone; people with a history of liver tumors shouldn’t take Opill either. However, it’s a good option for people at risk for blood clots, smokers, or migraine sufferers, especially those accompanied by visual disturbances (also known as auras).

Should you switch to the Opill?

Even with the FDA’s approval, it’s still unclear how much the progestin-only pill will cost. Its manufacturer Perrigo hasn’t set a price, although it has said the Opill will be within an affordable range.

Thanks to the Affordable Care Act, the majority of private health plans are obligated to provide coverage for birth control without any additional charges. A concerted legislative movement spearheaded by Democratic senator Patty Murray of Washington State is additionally seeking to guarantee insurers fully cover it without any fees or out-of-pocket expenses.

If costs are affordable, Edelman and Sopata say it may make sense for some individuals to switch over if they so choose. They also caution that anyone thinking of making the switch should consult with a healthcare provider before doing so, just so they can get the right counseling and education.

Editor’s Note: An earlier version of this story incorrectly stated Edelman’s Opill study on behalf of HRA Pharma noticed lower blood hormone levels in higher-weight individuals. This was a finding noticed in other studies looking at combined hormonal birth control. We are glad to correct the error.