A ruling expected soon from a Trump-appointed federal judge in Texas could halt the provision of a drug called mifepristone for use in abortions. This would potentially make the drug very difficult to come by in all states — including those where abortion is legal.
The decision in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration could revoke the F.D.A.’s 23-year-old approval of mifepristone, which is one of two drugs typically used during a medication abortion in the nation. That would be a highly unusual move — one that would show blatant disregard for the decades of scientific and clinical evidence showing that the drug is safe and effective. It also no doubt would be fought further in court, possibly even making it to the Supreme Court. Reproductive rights legal experts have called on the F.D.A. to ignore the decision from Judge Matthew Kacsmaryk if it does order the agency to rescind its approval for mifepristone.
But it’s important to know that if mifepristone became wholly unavailable in the United States tomorrow, such a decision would not be the end of abortion access in America, nor the end of access to safe medication abortion. That’s because there’s another drug that is a safe and effective abortion care option, and Americans may soon need to rely on it more than ever.
It has been eight months since Roe v. Wade was overturned, and abortion has since been banned in 13 states and counting. People in states where abortion is banned or severely restricted have been forced to travel hundreds of miles to clinics out of state. For those for whom travel is too expensive or time consuming, abortion pills provided by mail have been a vital option. Medication abortion already was the most common form of abortion, and since Roe was overturned, demand has surged for abortion pills.
Mifepristone, which when taken with a drug called misoprostol, accounts for more than half of abortions in the United States. Misoprostol can be and is frequently used on its own. The two drugs have been used together in the United States since the F.D.A. approved mifepristone in 2000, but around the world misoprostol — which causes the uterus to contract and expel the pregnancy — has for years been used by itself for abortion care.
In fact, misoprostol is regarded as the original medication abortion pill. We know from decades of clinical evidence that misoprostol used alone for medication abortion is safe and effective. Misoprostol alone is not widely used in America, but the medication is widely available and a sample protocol for abortion providers has been released in preparation for a potential shift in clinical practice.
The World Health Organization provides guidelines for using misoprostol alone for an abortion. For pregnancies of less than 12 weeks’ gestation, the W.H.O. recommends 800 micrograms of misoprostol placed under the tongue, in the cheeks or vaginally, with repeat doses as needed. For pregnancies at or beyond 12 weeks, the W.H.O. recommends 400 micrograms of misoprostol under the tongue, in the cheeks or vaginally repeated every three hours as needed. Some people use up to five doses. Misoprostol causes bleeding and cramping, and some people may also experience diarrhea, chills, fever, nausea or vomiting.
There is a growing body of evidence that misoprostol is effective for self-managed abortion (performing one’s own abortion without clinical supervision) and that it is safe. In Argentina and Nigeria, among people who used misoprostol alone to self-manage their abortion with support from a safe abortion hotline, 99 percent had a complete abortion. Other studies from Nigeria, Pakistan and Thailand show similarly high levels of effectiveness.
Recently, my co-authors and I published a U.S.-based study on the safety of misoprostol alone used for self-managed abortion, finding that overall 88 percent of users had a complete abortion, and very few people experienced adverse events or symptoms of a potential complication. People in the United States are knowledgeable about misoprostol, and people all over the world find it to be a highly acceptable medication abortion regimen.
Misoprostol was originally created to treat stomach ulcers, but in the early 1980s Brazilian feminists discovered that the medication could also induce abortion. Since this discovery, it has been used throughout Latin America, Asia and Africa. For decades feminist groups have supported people through safe self-managed abortion using misoprostol alone. We can look to this history for strategic guidance as we navigate the current abortion access crisis in the United States.
Because of misoprostol’s wide range of applications — including induction of labor, miscarriage management and prevention of postpartum hemorrhage — it is commonly stocked in U.S. pharmacies, and it is relatively inexpensive. Unlike mifepristone, it is not governed by the F.D.A’s Risk Evaluation and Mitigation Strategies, or REMS, classification, which has historically made mifepristone difficult to access. Across our Southern border, misoprostol is available over-the-counter in some Mexican pharmacies, and Mexican activists have mobilized to assist Americans seeking access to misoprostol.
For Americans in favor of abortion rights, there is hope in the implementation and expansion of models using just misoprostol for abortions in the United States. But it is also clear that even with Roe v. Wade overturned, conservative lawmakers and judges remain relentless in their attacks on abortion. Disproportionately, the people who would suffer from this decision would be those with fewer resources to combat unjust laws.
Anti-abortion laws and court decisions often aim to stoke unwarranted fear about the safety of abortion. So it’s important to remember that while this looming decision could be a major blow to abortion access in America, misoprostol alone remains a safe medication abortion option. It is critical that everyone who cares about American abortion access learns about misoprostol and its uses to prepare for what may soon be to come.
Dana M. Johnson is a Ph.D. candidate in public policy and demography at the University of Texas and a senior associate research scientist at Ibis Reproductive Health.
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