Abortion Pill Complications 22X Higher Than Previously Reported, Per New Study

A newly released analysis is raising serious questions about the safety profile of mifepristone, the drug responsible for over half of abortions in the United States. While abortion-rights advocates, corporate media outlets, and the U.S. Food and Drug Administration (FDA) maintain that the drug is “safe and effective,” a comprehensive study based on real-world insurance claims paints a far more concerning picture.

Described as the “largest known study of the abortion pill,” the report was conducted by Ethics and Public Policy Center President Ryan Anderson and Director of Data Analysis Jamie Bryan Hall. Using a massive dataset that included Medicaid, TRICARE, Medicare, Department of Veterans Affairs, and private insurance claims, the researchers analyzed 865,727 prescriptions of mifepristone distributed to 692,873 women between 2017 and 2023.

The findings are striking: approximately 10.9 percent of those chemical abortions—about 94,605 cases—involved potentially life-threatening “serious adverse events” within 45 days of taking the drug. These complications included emergency room visits, hemorrhage, sepsis, infection, and follow-up surgeries. This complication rate is at least 22 times higher than the <0.5 percent figure cited by the FDA on the Mifeprex label.

The researchers noted that some patients experienced complications in multiple categories, and that the 45-day window used for measurement was “conservative,” especially considering that the FDA has relied on studies using a timeframe of up to 72 days.

One chart from the study revealed that among women who sought post-abortion care within 45 days:

• 15.1% visited the emergency room,
• 8.5% required surgical treatment,
• 2.5% experienced hemorrhage,
• 1.9% suffered infections, and
• 0.9% were diagnosed with sepsis.

“These outcomes were drawn from actual claims data,” the researchers emphasized, “not modeled projections or self-reported surveys.” In Anderson’s words to The Federalist: “This study is the statistical equivalent of a category 5 hurricane hitting the prevailing narrative of the abortion industry. It reveals, based on real-world data, the shocking number of women who suffer serious medical consequences because of the abortion pill.”

The FDA originally approved mifepristone in 2000 based on 10 clinical trials involving only 30,966 patients—women who were described as “prescreened,” “generally healthy,” and treated in controlled environments. The authors of the new study argue that those trials are both outdated and unrepresentative of today’s broad and diverse patient base.

“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.

Despite repeated petitions from pro-life medical groups to revisit the approval of mifepristone, the FDA has consistently declined to take action. Critics argue the agency failed to meet its legal obligation to address the concerns. Meanwhile, regulatory oversight has continued to loosen. By 2016, the FDA under the Obama administration had altered the drug’s dosing, cut down the number of in-person doctor visits required, broadened who could prescribe it, and eliminated requirements to report non-fatal complications.

The Biden administration went further. In 2021, the FDA permanently allowed mifepristone to be delivered by mail, bypassing the need for a clinic visit. Pharmacies like Walgreens and CVS were later authorized to dispense the pill. As of 2023, a woman can obtain mifepristone with just one telehealth appointment with “any approved healthcare provider (not necessarily a physician)” and self-administer the drug at home. Alarmingly, prescribers are not required to report adverse events unless they learn the patient has died.

The study recommends that the FDA reinstate its original safety protocols. These would include requiring multiple in-person visits, physician-only prescribing, ultrasound confirmation of gestational age and the absence of ectopic pregnancy, and mandatory reporting of complications. The goal, according to the authors, is not only to reduce immediate harm but also to facilitate better long-term safety tracking.

“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 concludes.

While legal efforts to challenge the pill’s availability have so far been unsuccessful, the issue remains live. In 2023, the Supreme Court declined to weigh in on the merits of mifepristone’s approval, ruling that the plaintiffs lacked standing. However, Justice Brett Kavanaugh’s opinion left open the possibility for the Court to consider a more suitable challenge in the future.

SOURCE: THE FEDERALIST