ORLANDO, FL – A groundbreaking report released yesterday reveals the chemical abortion drug Mifepristone is 22 times more dangerous than the U.S. Food and Drug Administration (FDA) claims on its drug label. The Ethics and Public Policy Center (EPPC) conducted and published the study finding that one in 10 women experience a serious adverse health event within 45 days after taking Mifepristone for an abortion.

“Simply stated, Mifepristone, as used in real-world conditions, is not ‘safe and effective,’” wrote the researchers, which consisted of a team of scientists, board-certified obstetricians and gynecologists, analysts, and engineers.

Described as the “largest-known study of the abortion pill,” the EPPC analyzed 865,727 Mifepristone abortions under “real-world conditions” from 2017 to 2023 using an “all-payer insurance claims database.” In contrast, the report notes, the FDA relies on decade-old data from 10 clinical trials that involved just 30,966 “pre-screened” and “generally healthy” women. Under that small data set, which found less than 0.5 percent of women suffered serious adverse reactions, the FDA lets Danco Laboratories market Mifepristone, under the label “Mifeprex,” as “safe and effective.” However, the EPPC examined data that is more “broadly representative” of the women actually having Mifepristone abortions in America rather than just relying on data from the “carefully controlled regimen of care” of a clinical trial. These women would have had varying degrees of real-world “pre- and post-abortion health care,” if any care at all.

“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,” read the report. “10.93 percent of women experience sepsis, infection, hemorrhaging, or another serious or life-threatening adverse event within 45 days following a Mifepristone abortion.”

The specific rates of serious complications consisted of: 

• abortion-related emergency room visit (4.73 percent)
• hemorrhage (3.31 percent)
• infection (1.34 percent)
• ectopic pregnancy (0.35 percent)
• abortion-related hospitalization (0.66 percent)
• transfusion (0.15 percent)
• sepsis (0.10 percent)
• unspecified other abortion-specific complications (5.68 percent),
• other life-threatening adverse events (0.22 percent), including cardiac and pulmonary events, thrombosis, anaphylaxis, and the necessity of surgery.

Notably, nearly three percent of the adverse events required a follow-on surgical abortion due the abortion drug failing.

As the report states, the FDA initially approved Mifepristone in 2000 under a “little-used approval process” for new drugs treating serious or life-threatening illnesses. Under this process, FDA considered an unwanted pregnancy a “serious or life-threatening illness” and concluded Mifepristone was more effective than surgical abortion. Then, under the Obama and Biden administrations, the drug’s safeguards were heavily deregulated between 2016 to 2021 where it can now be used through the 10th week of pregnancy, can be prescribed by health care providers who are not physicians, can be prescribed online through telehealth appointments, can be sent through the mail, and adverse events are no longer required to be reported.

Due to the report’s findings, the EPPC recommended the FDA reinstate all of the abortion pill’s original safety protocols. Specifically, the researchers recommended: 

• Mifepristone should be prescribed only by physicians.
• A Mifepristone prescription should include three in-person physician visits.
• Mifepristone should be administered only in a clinic, medical office, or hospital, by or under the supervision of a physician.
• Physicians must be able to provide surgical intervention in cases of incomplete abortion or severe bleeding, or have made plans to provide such care through others.
• Health care providers should be required once again to report to the FDA (and manufacturers of Mifepristone) all serious adverse events resulting from the use of the drug.
• Mifepristone should only be prescribed to a woman who is confirmed by a physician to be in the first seven weeks of pregnancy, as originally required by the FDA. 

Liberty Counsel Action Chairman Mat Staver said, “This study from the Ethics and Public Policy Center shows that abortion is never safe for women and it certainly is not ‘health care.’ Chemical abortions harm women physically and emotionally and cruelly kill defenseless children in the womb. There is a deliberate strategy to misinform people about chemical abortion and the science clearly proves that it is unsafe and devastatingly harmful to women.” 

Liberty Counsel Action is a 501(c)(4), nonprofit, grassroots organization advancing religious and civil liberties, the sanctity of human life, the family, limited and responsible government, national security, and support for Israel in Washington D.C. and across America.