Mifepristone is a medication used as part of a two-drug regimen in medication abortions, but it is also used to treat miscarriages. Public awareness of the drug has risen as anti-abortion activists sue to retract its U.S. Food and Drug Administration approval at the federal level. Those who will experience early pregnancy loss are caught in the crossfire.
In addition, a recent Vanderbilt University Medical Center-led study shows years of mifepristone underuse, even before the fall of Roe v. Wade.
Mifepristone, which was approved by the FDA in 2000 for medical termination of pregnancy, softens the cervix and makes the uterus more susceptible to a second drug, misoprostol, which will prompt expelling of the tissue. Using the two in conjunction helps the process move almost twice as quickly and more effectively, says researcher Elise Boos with the VUMC Department of Obstetrics and Gynecology.
“In the current legislative environment, a conflation between miscarriage and abortion really threatens to undermine making evidence-based miscarriage management available to patients,” Boos tells Scene sister publication the Nashville Post.
The study recorded the use of mifepristone and misoprostol together from 2016 until it was backed by the American College of Obstetricians and Gynecologists in 2018, and compared those rates to 2018 through 2020.
Nationwide, just 0.54 percent of women treated for miscarriage received the two-medication regimen before the ACOG recommendation, and after that the percentage rose to 1.78 percent. In Southern states, that percentage was even lower, at 0.1 percent receiving both medications initially, and 0.2 percent after the guideline was updated. The researchers did not record a significant difference in states with abortion restrictions compared to unrestricted states. In unrestricted states, just 0.67 percent of women received both medications before 2018, which rose to 2.21 percent after the update. In the United States, about 1 in 10 pregnancies ends in miscarriage.
In pregnancy loss, patients can choose to wait for their body to expel the tissue on its own, which can take six to eight weeks, Boos says. Patients who wish to intervene can choose between medication or a surgical option, and the latter can also be made smoother by the use of mifepristone, Boos says.
“Many people, it appeals to them to induce a miscarriage at a known time, when they’re in a place where they have access to medications to manage their pain, they can have heavy bleeding in the privacy of their own home, et cetera,” Boos says. “I think for many women, being proactive gives them some power and agency in a situation that otherwise is often devoid of that.”
In the case of Alliance for Hippocratic Medicine v. the U.S. Food and Drug Administration, anti-abortion activists are attempting to reverse FDA approval of mifepristone. Tennessee Attorney General Jonathan Skrmetti was one of 22 Republican attorneys general to file a brief in support of the move. In addition, in March, Skrmetti sent letters to Walgreens, CVS and Rite Aid seeking confirmation that they will not sell or dispense mifepristone in Tennessee.
Abortion politics heighten stigma around mifepristone, Boos says, but the drug was already difficult to obtain. Despite being approved, it is highly regulated under the FDA’s Risk Evaluation and Mitigation Strategy (REMS), which was implemented in 2011.
In January, the REMS was edited to remove an in-person dispensing requirement but added a new pharmacy certification process, and kept mandated prescriber certification and prescriber and patient agreement forms. Organizations including ACOG, the American Medical Association and the American Academy of Family Physicians have all called on the FDA to remove the REMS completely to make mifepristone easier to access.
By the time REMS restrictions were officially loosened, it was already a felony for physicians in Tennessee to dispense abortion-inducing drugs by mail, due to the 2022 Tennessee Abortion-Inducing Drug Risk Protocol Act.
“That bill, even though it doesn't explicitly deal with mifepristone for miscarriage management, speaks about abortion inducing drugs in such a way that it's very reasonable to understand why clinicians would be disincentivized making those medicines available,” Boos says.
While Tennessee’s abortion ban has specific carve-outs for miscarriages or the removal of a dead fetus, the stigma and lack of access to mifepristone adds insult to injury for patients experiencing pregnancy loss, Boos says.
“People who are familiar with the law and providing this care will know and recognize that our ability to care for miscarriages is not impacted and should not be impacted by our abortion ban in Tennessee,” she says.
This article originally appeared via our sister publication the Nashville Post.
