A new study published today by the Ethics and Public Policy Center (EPPC) alleges that the abortion pill, mifepristone, is associated with a significantly higher rate of serious adverse events in women than what is currently reported on the drug’s label.
The study, based on an analysis of insurance claims data from 2017 to 2023 encompassing 865,727 prescribed mifepristone abortions, claims that 10.93 percent of women experienced complications such as sepsis, infection, or hemorrhaging within 45 days of taking the medication.
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Authored by Jamie Bryan Hall, Director of Data Analysis at EPPC, and Ryan T. Anderson, President of the organization, the report contends that this real-world rate of serious adverse events is “at least 22 times as high” as the “less than 0.5 percent” cited in clinical trials referenced on the drug label.
The authors argue that the Food and Drug Administration (FDA) should immediately reinstate stricter patient safety protocols that were in place when mifepristone was first approved. These protocols included requirements for multiple in-person office visits, physician-only prescribing, in-clinic administration, and mandatory reporting of all serious adverse events.
Furthermore, the study calls on the FDA to conduct a more thorough investigation into the potential harms of mifepristone and to reconsider its approval of the drug based on objective safety criteria.
“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 authors stated in their summary. They emphasized the large sample size of their study, which they claim is 28 times larger than the total number of participants in the FDA-cited clinical trials, and the recency of their data (2017-2023). They also highlight that their data reflects real-world conditions and a broad representation of women seeking mifepristone abortions in the U.S., unlike the potentially prescreened participants in clinical trials.
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The study outlines its methodology for identifying mifepristone abortions through procedure codes, prescriptions, and diagnosis codes. It also details how serious adverse events were identified using ICD-10 and CPT/HCPCS codes, drawing from sources such as the CDC’s Severe Maternal Morbidity indicators and the FDA’s Adverse Events Reporting System. These events were then graded by physicians based on the NIH Common Terminology Criteria for Adverse Events, with the study focusing on Grade 3 (severe) and Grade 4 (life-threatening) events occurring within 45 days post-abortion.
The authors conclude by reiterating their call for immediate action by the FDA to strengthen safety protocols and to re-evaluate the approval of mifepristone. They assert that “women deserve better than the abortion pill.”
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