Study: Rate Of Serious Or Life-Threatening Complications After Abortion Pill Is 22 Times Higher Than FDA Claims
Abortion advocates, their allies in the corporate media, and even the U.S. Food and Drug Administration insist the pill responsible for more than half of the nation’s abortions is “safe and effective.” A new, wide-ranging analysis of insurance claims regarding the abortion drug regimen, however, found that the rate of life-threatening complications due to mifepristone is at least 22 times higher than what the FDA and Danco Laboratories, manufacturer of mifepristone pill Mifeprex, suggest.
In the “largest known study of the abortion pill,” Ethics and Public Policy Center President Ryan Anderson and Director of Data Analysis Jamie Bryan Hall used purchased Medicaid, TRICARE, Medicare, Department of Veterans Affairs, and private medical insurance claim data to determine that 865,727 mifepristone abortion prescriptions for 692,873 women were handed out between 2017 and 2023.
Approximately 10.9 percent of those claims, or 94,605 chemical abortions, involved potentially life-threatening “serious adverse events” such as emergency room visits, hemorrhage, sepsis, infection, and/or follow-up surgeries for the women who had downed the abortion drug within the last 45 days.
That rate, which researchers adjusted to reflect “that some women suffer from adverse events in multiple categories,” is 22 times the FDA’s <0.5 percent estimation printed on the Mifeprex label. The researchers also suggest that the 45-day timeframe they used is “conservative, as some adverse events may present later (and studies relied on by the FDA used a timeframe as long as 72 days).”
“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.”
The FDA, the study notes, derived its mifepristone data from 10 clinical trials. In 2000, the agency used those trials to justify fast-tracking abortion pill approval despite ongoing concerns about dangerous and fatal complications.
The researchers not only warned that some of those trials are outdated and were conducted outside of the U.S., but they also emphasized the trials only included a fraction — approximately 30,966 hand-selected, “prescreened,” “generally healthy women” — of the mifepristone patients reflected in the insurance data.
“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 continues.
For more than two decades, pro-life doctors repeatedly asked the FDA to repeal its approval of the chemical abortion drug due to the life-threatening harm it causes women and babies, as The Federalist previously reported. The FDA repeatedly stonewalled the petitioners despite its legal obligation to address their concerns.
By the time the Obama administration was making its exit in 2016, the agency had worked overtime to expand the abortion pill’s use by changing its dosing, reducing the required number of doctor visits to obtain the drug, allowing more people than licensed doctors to prescribe the pill, and eliminating reporting standards for non-fatal complications from the pills.
When President Joe Biden took office in 2021, the FDA radically relaxed its already debated regulation to permanently allow abortion pills via mail. To further accommodate the Biden White House’s post-Roe activism, the FDA also permitted pharmacies like Walgreens and CVS to dispense mifepristone.
The study notes that as of 2023, a woman can obtain a mifepristone-induced abortion with “as little as one telehealth visit with any approved healthcare provider (not necessarily a physician)” and “self-administer drugs obtained from a mail-order pharmacy.” Even then, the study warns that a pill prescriber is not mandated to “report any adverse events unless he or she knows that a patient has died.”
“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 study concludes.
Changes like reinstating multiple in-person office visits, physician-only prescription, ultrasounds to confirm the gestational stage and rule out ectopic pregnancy, and mandated reporting of complications, the study suggests, could spare suffering women severe and even fatal fallout from the pill.
“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 researchers conclude.
Last year the Supreme Court declined to weigh in on the merits of the abortion pill’s approval, declaring that the coalition of medical professionals who challenged the Biden administration’s mail-order expansion of the drug did not have legal standing. The opinion penned by Justice Brett Kavanaugh, however, left the door open for the high bench to consider a stronger challenge if one should emerge.
Jordan Boyd is a staff writer at The Federalist and producer of The Federalist Radio Hour. Her work has also been featured in The Daily Wire, Fox News, and RealClearPolitics. Jordan graduated from Baylor University where she majored in political science and minored in journalism. Follow her on X @jordanboydtx.
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