When people refer to “the abortion pill,” they’re usually talking about mifepristone, the progesterone-inhibiting drug that was developed in France in the 1980s and approved in the U.S. in 2000. This month, a right-wing federal judge appointed by Donald Trump could outlaw that pill nationwide in response to a lawsuit brought by anti-abortion activists in Texas.
It’s an alarming possibility that underscores the recklessness of giving politicians and appointees full authority over the nation’s reproductive health: An unelected official could singlehandedly revoke the FDA’s approval of a safe, widely used medication—and the Supreme Court may be inclined to let him.
Since more than half the nation’s abortions are performed with medication—as opposed to in-office procedures—the outcome of the case could interrupt access to abortion across the country, even in blue states where abortion is legal.
But there’s an alternative: Mifepristone is only one of two drugs consumed in a standard medication abortion. In higher doses, the second drug, misoprostol, can also terminate a pregnancy on its own.
Misoprostol, which was originally approved to prevent and treat stomach ulcers, was first found to be an effective abortifacient in the 1980s in Brazil. Because it was sold over the counter there, women began using it to circumvent repressive restrictions on abortion. In countries where mifepristone is not available or broadly accessible, misoprostol is still used alone for abortions as a standard course of treatment.
And since misoprostol is an essential drug prescribed for purposes other than abortion, it is unlikely to be subject to a blanket, politically-motivated ban. This means that doctors will be able to continue providing medication abortions where they are legal in the U.S., even if mifepristone is outlawed. They’ll just have to use a different protocol.
Across the country, abortion providers are preparing for the possibility that misoprostol will become the only abortion drug available, expecting the worst from the ultra-conservative Texas judge and the right-leaning Supreme Court. On its own, misoprostol is generally not as effective as when taken in conjunction with mifepristone, so it requires a slightly different approach.
“It’s very reminiscent, for a lot of us, of when we knew that the fall of Roe was coming down the pipeline a year or two beforehand,” said Jennifer Conti, an OB/GYN and adjunct clinical assistant professor at Stanford University. “At that point, there was a lot more shock. And at this point, we’re sort of used to the shock, and instead of just sitting with that shock, we’re really trying to come up with offensive moves or plans to try to combat the inevitable.”
Some doctors are re-acquainting themselves with the ways clinicians did medication abortions before mifepristone was approved by the FDA, either with misoprostol alone or with a combination of misoprostol and methotrexate, a chemotherapy drug used to treat autoimmune diseases and ectopic pregnancies. If mifepristone goes away, a misoprostol-only abortion will likely become the standard.
In other words, doctors and pharmacies in the U.S. already have access to a nearly-as-good alternative to the current protocol. Still, Conti worries that a mifepristone ban will cause confusion about what kinds of care remain legal. That’s the goal of anti-abortion activists, she said, “because if you put out this messaging that not just mifepristone but medication abortion is now illegal, people don’t realize that mifepristone is ideal, but it’s not necessary, and that you can still have a medication abortion.”
The medical director of Just the Pill, a nonprofit online clinic that mails abortion medication to patients in four U.S. states, said the organization is prepared to switch to a misoprostol-only protocol “if the Texas judge rules in the way that it’s expected.” A representative from Hey Jane, another site that does virtual consultations and mails abortion pills, said many of the group’s practitioners have already provided misoprostol-only abortions, and they are ready to fully pivot if mifepristone is banned. Planned Parenthood confirmed to Jezebel that its facilities are ready to offer misoprostol-only abortions, too.
Providers agree that there is no medical reason to restrict or ban the use of mifepristone. Though the Texas lawsuit claims that the FDA recklessly fast-tracked the drug’s approval in 2000, arguing that the agency disregarded potential adverse effects of the medication, decades of research and several million abortions with mifepristone—including more than 3.7 million in the U.S.—have shown the drug to be safer than Tylenol. A two-drug medication abortion is “the gold standard in the U.S. It’s the most effective combination worldwide,” said Melissa Grant, chief operations officer at Carafem, which offers mail-order abortion medication and operates clinics in four U.S. cities.
Essentially, if the Texas judge bans mifepristone, he will require every medication abortion patient to use a different regimen for purely political reasons.
When mifepristone is available, a patient first takes that pill, which causes her uterine lining to begin to break down. A day or two later, she allows four tablets of misoprostol to dissolve under her tongue, in between her cheek and gum, or in her vagina, triggering minor contractions that empty the contents of the uterus. By contrast, misoprostol-only abortion typically involves taking three doses of four misoprostol tablets, with three hours between each dose.
Technically, taking misoprostol by itself to terminate a pregnancy is considered an off-label use, since the FDA has only approved the medication for gastric ulcers. But off-label prescriptions for drugs are common in the U.S., and misoprostol is already regularly used off-label to induce labor, treat postpartum hemorrhage, or soften a patient’s cervix before inserting an IUD.
Studies in countries around the world have shown misoprostol to be a safe method for terminating a pregnancy on its own, though it is less effective than the two-drug protocol. A systematic review of clinical trials found that using just misoprostol yields a completed abortion less than 80 percent of the time. But in observational studies, when researchers look at women who use misoprostol to self-manage an abortion outside a clinical setting, efficacy rates can climb past 90 percent—in part because some women’s bodies take longer than a week to fully expel the pregnancy, which could count as a failure in a clinical trial.
“We now find effectiveness rates with misoprostol by itself can be as high as 95 percent,” Grant said. “Mifepristone and misoprostol are about 98 percent. So we’re really talking about a small difference overall.”
Carafem has been offering misoprostol-only abortions for years. In 2020, as GOP-led state legislatures passed increasing restrictions on abortion, Carafem leadership realized that mifepristone’s legality was not a forever guarantee. Clinicians began offering two options to their patients who wanted abortion medication: Misoprostol only, or mifepristone and misoprostol. Patients were told that misoprostol alone would require multiple doses of the medication taken over the course of several hours, and that there was a slightly greater chance of failure.
Still, between 12 and 15 percent of Carafem’s medication abortion patients opt to take misoprostol alone. Some are not able to take mifepristone for medical reasons or prefer the lower price point of misoprostol; others see misoprostol as a trusted option because they know people who have used it by itself to terminate a pregnancy, since the drug can be easily obtained by mail or over the counter in Mexico.
Historically, the more stringently regulated mifepristone has gotten, the more attractive misoprostol-only abortions have become. In early 2021, after the Supreme Court reinstated an FDA ban on mailing mifepristone that had been suspended during the pandemic, Carafem was forced to require patients who wanted the two-drug regimen to visit a clinic to pick up their pills. (The FDA permanently removed the ban later that year.) During this time, about 80 percent of Carafem’s medication abortion patients chose a misoprostol-only abortion instead of the two-drug regimen, since it meant being able to receive their pills in the mail. To them, avoiding an in-person visit was worth the higher risk of having to repeat the procedure. Patients who remain pregnant are offered more misoprostol or scheduled for an aspiration abortion in a clinic if they are able to travel to one.
“It’s really important when you use misoprostol alone—because there is a slightly increased risk that you may have an ongoing pregnancy—that you stay in close contact with your medical provider, if you’re choosing to use it through a medical provider,” Grant said, adding that patients must be alert “for symptoms that indicate that you’ve had a successful abortion.”
If pregnancy symptoms do not decrease within a few days after a medication abortion, patients are encouraged to take a blood test for pregnancy. If pregnancy symptoms abate after the abortion, taking a urine test a few weeks later will suffice.
The misoprostol-only protocol can change the patient experience in other ways. According to Grant, since the drug often causes pain with uterine cramping and, occasionally, diarrhea or vomiting, some patients balk when it’s time to take their second and third doses. (In a two-drug medication abortion, patients only take a single dose of misoprostol, negating the need to consume more of the drug in the midst of its unpleasant effects.) Carafem employees tell patients that though the medication is causing the discomfort, it will also be the thing that stops it, as most people quickly feel better after the pregnancy is passed.
Carafem is compiling these kinds of observations and data from its misoprostol-only practice to share with a group of researchers, in hopes of aiding practitioners who may soon be unable to prescribe their first-choice treatment. Though misoprostol’s widespread availability—and its over-the-counter status in other countries—has long made it a popular choice for people managing their own abortions outside a clinical context, there has only been one study of misoprostol-only abortions in the U.S.
“As far as I know, we’re the only abortion provider who’s had this much experience with it in the U.S.,” Grant said. “I think we were trying to predict something that I hoped would never happen. And it’s happened.”