The drug mifepristone, known widely as the abortion pill, is much more dangerous than previously reported, according to the largest-known study to date on its effects.

The study, released by the Ethics & Public Policy Center, analyzed data from an insurance claims database that included 865,727 prescribed mifepristone abortions from 2017-2023.

Within 45 days of a mifepristone abortion, 10.93% of the women experienced serious complications such as sepsis, infection, hemorrhage, “or another serious adverse effect,” which is 22 times higher than the data the FDA has reported, the study said.

The U.S Food and Drug Administration has relied on clinical trial data that showed serious complications resulting from mifepristone abortions in only 0.5% of the women who used it. The data the FDA and the drug manufacturer relied on drew data from a mere 859 women in the U.S. and 1,800 in France, where the drug originated.

“Danco Laboratories markets Mifeprex as ‘the safe and effective abortion pill,’ but our research shows that mifepristone abortion, as currently practiced in the U.S., is not safe and effective,” the Ethics and Public Policy Center said in a summary of the study.

The FDA first approved the abortion pill in 2000, but with protocols requiring three in-person doctor visits. Further, the drug could only be dispensed in the doctor’s office, with a requirement of one follow-up visit and mandatory reporting of any adverse events.

Then in 2016, after years of pressure from the abortion lobby, the Obama administration removed nearly all safeguards, requiring only one in-person visit with a physician, who alone could dispense the drug. In 2023, the Biden administration removed those two remaining safeguards, allowing pharmacies to dispense mifepristone in person and through the mail.

“The FDA should 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 report said.

Moreover, “The FDA should further investigate the harm mifepristone causes to women and, based on objective safety criteria, reconsider its approval altogether.”

The most common “adverse events” related to the mifepristone abortions were emergency room visits related to the abortion (4.73%); hemorrhage (3.31%); surgery needed to complete the abortion (2.84%); infection (1.34%); and “other abortion-specific complications” (5.68%).

The Ethics and Public Policy Center notes that “the FDA approved [mifepristone] under a little-used approval process for ‘certain new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments.’”

The abortion pill regimen actually involves two drugs—the ingestion of mifepristone followed several days later by another drug, misoprostol. But In the last decade, more awareness has been raised by pro-life advocates to what is termed “abortion pill reversal.”

Many pro-life pregnancy clinics have been helping expectant mothers who have taken mifepristone and then changed their minds. Often, the abortion can be stopped by replacing the second drug with doses of progesterone within 24 hours. Progesterone is a natural hormone needed to sustain pregnancy and has been used for decades to prevent miscarriage and forestall preterm labor safely and effectively. 

For example, the pro-life group Heartbeat International offers the Abortion Pill Rescue Network, with a toll-free hotline and additional information at AbortionPillReversal.com. The group says it answers an average of 200 “mission-critical” calls a month from women seeking to save their babies after taking the abortion pill.

On Monday in a letter to FDA Commissioner Marty Makary, Missouri Sen. Josh Hawley called on the agency to “revisit and restore” the previous safeguards of the abortion pill. “Today,” he wrote, “mifepristone can be delivered via mail and without any medical supervision whatsoever—jeopardizing the safety of women who use the drug. … The time to act is now.”

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