A new study reveals that the abortion pill mifepristone carries a rate of serious or life-threatening complications 22 times higher than what the U.S. Food and Drug Administration (FDA) and the drug’s manufacturer, Danco Laboratories, have claimed.
The study raises serious concerns about the safety of the dangerous abortion pill.
The analysis, described as the “largest known study of the abortion pill,” was conducted by Ethics and Public Policy Center President Ryan Anderson and Director of Data Analysis Jamie Bryan Hall.
The authors maintain this is the largest ever study of the abortion pill.
It examined insurance claims data from Medicaid, TRICARE, Medicare, the Department of Veterans Affairs, and private insurers, covering 865,727 mifepristone prescriptions dispensed to 692,873 women between 2017 and 2023.
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According to the study, approximately 10.9% of these prescriptions—94,605 chemical abortions—resulted in “serious adverse events” such as emergency room visits, hemorrhages, sepsis, infections, or follow-up surgeries within 45 days of taking the drug. This rate starkly contrasts with the FDA’s reported complication rate, which pro-life advocates argue has been dangerously understated.
“The women in our dataset receive (or fail to receive) pre- and post-abortion healthcare of the real-world quality that prevails in the U.S. today, not the carefully controlled regimen of care that ordinarily prevails in a clinical trial,” the study says
“This study is the statistical equivalent of a category 5 hurricane hitting the prevailing narrative of the abortion industry,” Anderson said in a statement to The Federalist. “It reveals, based on real-world data, the shocking number of women who suffer serious medical consequences because of the abortion pill.”
Pro-life medical professionals have long criticized the FDA’s approval of mifepristone, first granted in 2000 under an accelerated process intended for drugs treating serious or life-threatening conditions. Critics, including the Alliance for Hippocratic Medicine, argue that pregnancy does not qualify as such a condition and that the agency overlooked significant risks to women’s health.
“The FDA should reinstate the original patient safety protocols that were required when mifepristone was first approved. Doing so will likely reduce the harms to women and permit better monitoring to determine whether this drug should remain on the market,” the authors note. “The FDA should further investigate the harm this drug causes to women and, based on objective safety criteria, reconsider its approval altogether. Women deserve better than the abortion pill.”
The study’s findings come amid ongoing legal and policy battles over mifepristone.
In 2021, the Biden administration relaxed regulations, permanently allowing the dangerous abortion drug to be dispensed via mail and permitting pharmacies like Walgreens and CVS to distribute it. The FDA also reduced oversight, eliminating requirements for prescribers to report non-fatal adverse events unless a patient dies.
Pro-life advocates argue these changes have exacerbated risks, particularly as women can now obtain mifepristone through a single telehealth visit and self-administer it without in-person medical supervision. The study warns that this lack of oversight increases the likelihood of undetected complications, such as ectopic pregnancies or Rh alloimmunization, which can lead to severe bleeding or future pregnancy complications.
Last year, the Supreme Court declined to rule on the merits of mifepristone’s approval, citing a lack of legal standing for the challenging medical professionals. However, Justice Brett Kavanaugh’s opinion left open the possibility for future challenges, a prospect pro-life groups are pursuing in light of the new data.
The study calls for the FDA to reinstate original safety protocols, such as mandatory in-person visits and adverse event reporting, to better monitor mifepristone’s risks. It also urges a reevaluation of the drug’s approval status.
