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A bombshell study published Monday has revealed nearly 11% of women experience severe or life-threatening complications after an abortion via the drug mifepristone – a rate that is 22 times higher than indicated on the drug’s label approved by the federal Food and Drug Administration (FDA).
A research team at the Washington, D.C.-based Ethics and Public Policy Center (EPPC) analyzed 865,727 mifepristone abortions that occurred between 2017 and 2023, a number that is “28 times larger than in all FDA clinical trials combined.”
“This largest-known study of the abortion pill is based on analysis of data from an all-payer insurance claims database,” write Jamie Bryan Hall and Ryan T. Anderson of EPPC for the study titled “The Abortion Pill Harms Women.”
According to the study, “10.93 percent of women experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion.”
“The real-world rate of serious adverse events following mifepristone abortions is at least 22 times as high as the summary figure of ‘less than 0.5 percent’ in clinical trials reported on the drug label,” Hall and Anderson observe.
The FDA began to gradually relax restrictions on mifepristone during the Obama and Biden administrations, ultimately allowing the drug to be used up to 10 weeks of pregnancy, with no required in-person doctor visits or reporting of adverse events.
The weakened restrictions on mifepristone appear to have enabled a drug-induced abortion to become a “DIY” (do-in-yourself) procedure.
“[A] mifepristone abortion now requires as little as one telehealth visit with any approved healthcare provider (not necessarily a physician),” Hall and Anderson observe. “[A] woman may self-administer drugs obtained from a mail-order pharmacy.”
Easy access to DIY abortions has occurred just as their prevalence has also increased dramatically.
“Chemical abortions—the vast majority of which are performed using a combination of mifepristone and misoprostol—now account for roughly two-thirds of all abortions in the United States,” the researchers explain.
Given the finding that complications from drug-induced abortions appear to be far greater than what the FDA has reported, EPPC calls for the agency to “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.”
“The FDA should further investigate the harm mifepristone causes to women and, based on objective safety criteria, reconsider its approval altogether,” the authors assert.
“Many patients obtain mifepristone through the mail through ‘telemedicine’ apps that require little more than a few clicks and virtually no evaluation,” writes psychiatrist and EPPC scholar Dr. Aaron Kheriaty at his column “Human Flourishing.”
“The pill is then shipped across state lines, making it almost impossible for states to regulate or monitor its use,” he explains. “Fierce debates about abortion in our society often prevent objective analysis of data on the topic; however, given that chemical abortions now account for two-thirds of all abortions, these findings deserve close scrutiny and attention.”
Based on the study’s results, Missouri Republican Sen. Josh Hawley sent a letter Monday afternoon to FDA Commissioner Dr. Marty Makary, urging him to “restore the FDA’s longstanding safety measures” regarding mifepristone.
“You have stated publicly: ‘If the data suggests something or tells us that there’s a real signal, we can’t promise we’re not going to act on that data,’” Hawley reminded Makary. “The time to act is now. It is time to revisit and restore the FDA’s longstanding safety measures governing mifepristone.”
Similarly, Montana Republican Sen. Steve Daines reacted to the study’s shocking results.
“The science is clear: the abortion pill is not safe for women, and it never has been,” he said. “This recent study is proof that pro-abortion advocates care more about promoting their radical agenda than they do about women’s health. I urge the FDA to reinstate safety protocols for mifepristone, so that we can protect the health of women and uphold the dignity of life.”
Alliance Defending Freedom and the American Association of Pro-Life Obstetricians and Gynecologists likewise posted reactions to the study on the X platform: