An alarming new study revealed that one of the FDA’s most trusted abortion drugs may be very dangerous for women, with cited risks including sepsis, hemorrhaging, and more, leading one U.S. senator to implore FDA Commissioner Marty Makary to reevaluate the drug.
For context, the study, which was published by The Ethics and Public Policy Center (EPPC) on April 28, 2025, investigated the safety of Mifeprex, a chemical abortion pill that was reportedly used to perform 865,727 abortions between 2017 and 2023. The results of the study revealed that the drug carried high risks of several serious health issues, and the authors called for the FDA to investigate further.
In the study, authored by Jamie Bryan Hall and Ryan T. Anderson, risks associated with taking Mifeprex were outlined in detail, with the authors explaining that “10.93 percent of women experience sepsis, infection, hemorrhaging, or another serious or life-threatening adverse event within 45 days following a [Mifeprex] abortion.”
Furthermore, the authors of the study clarified that the risks associated with Mifeprex are “far greater than the summary figure of ‘less than 0.5 percent’ in clinical trials reported on the drug label.” They added, “Simply stated, mifepristone, as used in real-world conditions, is not ‘safe and effective.’”
In addition, the study’s authors pointed out that their observational analysis of the results of using Mifeprex is “to our knowledge, the most comprehensive study of chemical abortion safety ever conducted in the U.S.” They also clarified that they pulled data from “real-world insurance claims data for 865,727 prescribed mifepristone abortions, broadly representative of women who obtain mifepristone abortions in the U.S. today.”
After presenting their findings, the authors of the study argued that its results have major policy implications, saying, “The FDA should reinstate the original patent safety protocols that were required when mifepristone was first approved.” They added, “Doing so will likely reduce the harms to women and permit better monitoring to determine whether this drug should remain on the market.”
Following the release of the study, Sen. Josh Hawley (R-MO) wrote a letter to Food and Drug Administration Commissioner Marty Makary, in which the senator cited the EPPC’s research and admonished Commissioner Makary to update the standards for Mifeprex. Sen. Hawley wrote, “Just last week, you said that you had ‘no plans to take action’ on mifepristone,” Hawley wrote. “Yet during your confirmation hearing, you pledged to me that you would ‘review the totality of the data and ongoing data’ to inform action on the drug.”
Continuing, Sen. Hawley told Commissioner Makary, “I urge you to follow this new data…The health and safety of American women depend on it.” He later added, “Today, mifepristone can be delivered via mail and without any medical supervision whatsoever — jeopardizing the safety of women who use the drug.”
Watch coverage of the widespread use of the abortion pill:
Featured image credit: screengrab from the embedded video