Imagine losing a wanted pregnancy to miscarriage and then not getting the medication that could lower your risk of bleeding, shorten your recovery time, and give you a greater chance of not needing additional medical interventions. That’s what’s happening to pregnant patients across the nation as the drug mifepristone, used in conjunction with misoprostol to induce abortion, has become tightly regulated by federal and state governments.
Mifepristone, approved by the Food and Drug Administration in 2000, is used in over half the abortions performed in the United States. In off-label use, mifepristone and misoprostol are used in combination to manage miscarriage, which occurs in 10% to 20% of all pregnancies.
Mifepristone is regulated by the FDA under the “Risk Evaluation and Mitigation Strategy,” or REMS, which means the medication can only be prescribed by a physician, and pharmacies, hospitals, and clinics must meet specific requirements in order to dispense it. All prescribers must complete a Prescriber and Patient Agreement form, which the American Civil Liberties Union says impacts access.
According to a study published in July, only 1% of all miscarriages were treated with the combination of mifepristone and misoprostol even before the U.S. Supreme Court overturned Roe v. Wade in June 2022; the other 99% were treated with misoprostol alone.
A 2018 study published in the New England Journal of Medicine found that “mifepristone followed by treatment with misoprostol resulted in a higher likelihood of successful management of first-trimester pregnancy loss than treatment with misoprostol alone.”
There are three options for handling a miscarriage. A patient can let the miscarriage progress naturally, a process called “expectant management”: A miscarriage can begin about two weeks after a fetus has died. It then takes from two to eight weeks more for the tissue to pass from the body naturally. If it doesn’t pass, then a patient can take mifepristone followed by misoprostol. The third option is surgical, a procedure called suction dilation and curettage, which can be required if a patient is bleeding heavily or if there are signs of infection.
“I think that even in the prescriber level, there’s just an added layer of complexity,” Dr. Allison Linton, associate medical director for Planned Parenthood of Wisconsin, tells the American Independent. “And unfortunately, stigma as well. You are signing up to order a medication that is most commonly thought of as being a part of a medication abortion, even if that’s not what you are going to be using it for.”
Mifepristone has been under attack of late. On April 7, Texas U.S. District Court Judge Matthew Kacsmaryk suspended the Food and Drug Administration’s 23-year-old approval of the drug, claiming the original approval process had been unlawful.
The Justice Department and Danco Laboratories, the manufacturer of mifepristone, petitioned the 5th U.S. Circuit Court of Appeals to place both short- and long-term stays on Kacsmaryk’s ruling while the case winds its way through the appeals process. The medication has remained on the market with restrictions while litigation continues.
All patients who receive mifepristone are required to sign a form acknowledging that they’re taking the drug to end a pregnancy, even if they’re taking it for miscarriage care.
“I do think that from the patient level as well, there’s just an association with an elective termination or a consensual termination of pregnancy that maybe that person is uncomfortable with,” Linton says.
In an interview published on the website Stateline, a patient from Pennsylvania said that because her OB-GYN could not prescribe mifepristone for her miscarriage, she was sent to a clinic: “It did feel kind of cruel to send me to what was effectively an abortion clinic for care of the loss of my wanted pregnancy.”
“In medicine, our whole goal is always to try to find the most effective regimen with the least number of risks and side effects,” Linton says. “Data has shown us that the combination of [misoprostol and mifepristone] is the most effective regimen with the least number of side effects. And so we are therefore removing a standard of care, we are removing the best option.”