
Chemical Abortion Far More Dangerous to Women Than FDA Admits, Research Shows

The rate of serious adverse events after chemical abortion is at least 22 times as high as the FDA says, according to new data.
F or decades, the pro-life movement has maintained that every abortion has at least two victims: the unborn child and the pregnant mother. Numbers from a new report reaffirm that, far from being a health-care solution, chemical abortion poses significant physical risks to women.
This morning, the Ethics and Public Policy Center, where I am a fellow, released a paper that is the largest-known study of the abortion pill’s aftereffects for women. The research shows that chemical abortion is considerably more dangerous to pregnant women than the Food and Drug Administration presently admits.
Chemical abortions use two drugs: mifepristone, which blocks progesterone from sustaining the unborn child, and misoprostol, which causes contractions that expel the unborn child. According to this new research, nearly 11 percent of women “experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion.”
The drug label for mifepristone, by contrast, claims that “less than 0.5 percent” of women experienced a serious adverse event based on results of clinical trials. In other words, the rate of serious adverse events following chemical abortions appears to be at least 22 times as high as the summary figure that the FDA discloses.
This new research is based on an analysis of data from an all-payer insurance claims database, including more than 865,000 prescribed chemical abortions between 2017 and 2023. The 0.5 percent rate presented by abortion-pill manufacturer Danco Laboratories and the FDA relies on information from ten clinical trials with just shy of 31,000 participants. This new dataset covers 28 times as many chemical abortions as were included in all the FDA-cited clinical trials combined. This data is also more current and more representative of the American population than the data that the FDA relies on for its figures.
This serves as a reminder that supporters of legal abortion have politicized chemical abortion at the expense of women’s health and safety, even as this type of abortion becomes more common and regulations around it have become far less careful. According to the most recent estimates from the Guttmacher Institute, chemical abortions account for nearly two-thirds of all abortions in the U.S. each year, a figure that has been on the rise in the wake of state pro-life laws enacted after the 2022 Supreme Court decision in Dobbs v. Jackson Women’s Health Organization.
Under the Biden administration, the FDA loosened its safety protocols to permit women to obtain chemical-abortion drugs without ever seeing a physician in person, or even without consulting a physician at all. Previously, the FDA required that women take mifepristone “only in a clinic, medical office, or hospital, by or under the supervision of a physician, able to assess the gestational age of an embryo and to diagnose ectopic pregnancies.” Women can now obtain chemical abortions via telemedicine and the mail, as well as from any “certified prescriber,” a category that includes non-physicians such as physician assistants. This exposes women to a number of risks, especially in cases of an undiagnosed ectopic pregnancy or if a pregnancy is further along than a woman believes. In such cases, chemical-abortion drugs could cause severe hemorrhaging or other complications requiring hospitalization and surgery.
In light of these significant risks and this new research undermining the data that the FDA relies on, the FDA should reinstate its previous safety regulations for chemical abortions and once more require full, accurate reporting of all side effects and adverse events. The significant disparity between this research and the FDA’s own numbers should prompt the administration to more thoroughly study the risks and harms of mifepristone — and seriously reconsider its approval altogether.