A new, first-of-its-kind study asserts that serious adverse events from mifepristone, the first drug in the abortion pill regimen, occur at a rate approximately 22 times higher than the rate reported on the Food and Drug Administration’s (FDA) label for the drug.
The study, “The Abortion Pill Harms Women,” published by the Ethics and Public Policy Center (EPPC), states that nearly 11% of women (10.93%) experience sepsis, infection, hemorrhaging, or other serious or life-threatening adverse events following a mifepristone abortion. This means one in ten women experience at least one serious complication from taking mifepristone within 45 days — 22 times higher than the “less than 0.5 percent” serious adverse events rate reported by the FDA on the mifepristone label, according to this study. The study authors state that serious adverse events in multiple categories were accounted for in the reported rate.
The study examines the largest dataset to date regarding the abortion pill’s serious adverse events and is based on a HIPAA-compliant analysis of an insurance claims database that includes private health insurance, Medicaid, Medicare, TRICARE, and the Department of Veterans Affairs (VA). Researchers state that they reviewed 865,727 prescribed mifepristone abortions that took place from 2017 to 2023, following the official FDA definition of “serious adverse event” when reviewing the data. This dataset is 28 times larger than the combined 10 clinical trials upon which the FDA relied upon for the drug’s labeled risk.
The researchers also point out that “The data excludes transactions for which the insurer is also the provider (as is the case with some HMOs and much VA care), as well as cash pay transactions (which are disproportionately common for abortion).”
“Simply stated, mifepristone, as used in real-world conditions, is not ‘safe and effective,'” the study’s authors stated.
Figure 1, Serious Adverse Events, EPPC study, “Abortion Harms Women”
The current FDA-approved drug label warning is based on the results of 10 clinical trials that included just 30,966 women, 0.5% of whom reported serious adverse reactions. Some of those trials date as far back as 1983.
Significantly, EPPC noted that the women in the large insurance database it used for its study were “not a prescreened group of generally healthy women recruited into various clinical trials conducted at different times around the world.”
Study authors, EPPC Director of Data Analysis Jamie Bryan Hall and EPPC President Ryan T. Anderson, are calling on the FDA to revisit its previous research on mifepristone and reconsider the current regulation of mifepristone, which was scaled back substantially under the Obama and Biden administrations.
Anderson stated that the study “reveals, based on real-world data, the shocking number of women who suffer serious medical consequences because of the abortion pill.” In the summary of the study, the authors recommend: “The FDA should immediately reinstate its earlier, stronger patient safety protocols to ensure physician responsibility for women who take mifepristone under their care, as well as mandate full reporting of its side effects,” and “The FDA should further investigate the harm mifepristone causes to women and, based on objective safety criteria, reconsider its approval altogether.”
While Planned Parenthood claims the abortion pill is “safer than many other medicines like penicillin, Tylenol, and Viagra,” a study conducted by pro-abortion group Gynuity, released in 2021, found that 6% of women who took the abortion pill required a visit to the ER or urgent care for complications. That’s 107 times greater than the rate for acetaminophen/Tylenol (.056%) based on this analysis, and 33 times greater than the rate for penicillin (0.18%) based on this analysis. When compared to the new research from EPPC showing a 10.93% “serious adverse event” rate for the abortion pill, it becomes even more evident that Planned Parenthood’s claim is false.
Live Action founder and president Lila Rose reacted to the new study in a press release, stating:
The abortion pill is not medicine. It is a lethal drug that kills an innocent child and endangers her mother. The FDA has abandoned its duty to protect women and children, fast-tracking mifepristone through lies and stripping away even the most basic safety measures.
This is not healthcare. It is reckless, it is violent, and it must end. Mifepristone should not merely be regulated — it must be pulled from the market and banned outright.
Mifepristone was first approved for use as the abortion pill RU-486 in the United States in 2000 under the Bill Clinton administration, with several safety regulations in place. It was approved for up to seven weeks under the original Risk Evaluation and Mitigation Strategy (REMS), which stated that women taking the abortion pill must have three in-person visits with the prescriber, who had to be a medical doctor. Mifepristone could only be administered in a clinic, medical office, or hospital under the supervision of a physician who was able to assess the gestational age of the child and diagnose an ectopic pregnancy.
Figure 2, Weakening FDA Safeguards for Mifepristone, EPPC study, “Abortion Harms Women”
Changes made to the REMS guidelines under Obama in 2016 and Biden in 2023 weakened safety requirements in order to increase access to the abortion pill.
Today, a woman can order the abortion pill with just one telehealth visit with any approved healthcare provider and can self-administer mifepristone that she obtains through a mail-order pharmacy. Prescribers of mifepristone no longer need to report any adverse events unless a patient dies after the administration of the drug.
A recent FDA report estimates that as of December 2024, 7.5 million women have used mifepristone (200mg) “for medical termination of pregnancy.” The EPPC study researchers said that expanded access to abortion drugs makes it “increasingly important to understand the risks and harms to women from chemical abortion in general and from mifepristone in particular.”
See more on this study at StopHarmingWomen.org.
Editor’s Note, 4/28/25: This post has been updated to include remarks from Live Action founder and president Lila Rose and website information.
