‘Not safe’: Serious adverse events from abortion pill are 22 times higher than claim on label

One in ten patients experience a “serious adverse event” after taking the abortion pill, according to a study released Monday by the Ethics and Public Policy Center (EPPC), a conservative think tank and advocacy group.

The study found that 10.93% of women experienced sepsis, infection, hemorrhaging, or another serious adverse event within 45 days after a mifepristone abortion. The real-world rate of serious adverse events after mifepristone abortions is at least 22 times as high as the summary figure of “less than 0.5%” in clinical trials reported on the drug label, according to the study.

Mifepristone, when used together with another medication called misoprostol, is used to have an abortion during the first ten weeks of pregnancy, according to the U.S. Food and Drug Administration (FDA). Danco Laboratories, a pharmaceutical distributor based in Manhattan, distributes mifepristone under the brand name Mifeprex, and claims on their website that the drug is “safe and effective.”

The study, which the EPPC claims to be the largest-known review of the abortion pill conducted in the U.S., is based on analysis of data from an all-payer insurance claims database that includes 865,727 prescribed mifepristone abortions from 2017 to 2023.

“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 EPPC wrote in the study. “The manufacturer and the FDA rely on the results of 10 clinical trials with a total of 30,966 participants, less than 0.5% of whom reportedly experienced serious adverse reactions. In contrast, we analyzed real-world insurance claims data for 865,727 prescribed mifepristone abortions, broadly representative of women who obtain mifepristone abortions in the U.S. today, and we find a serious adverse event rate of 10.93%—at least 22 times as high as the summary figure reported on the drug label.”

“Simply stated, mifepristone, as used in real-world conditions, is not ‘safe and effective,’” the think tank went on to write.

With many states implementing pro-life laws after the Supreme Court overturned Roe v. Wade in June 2022, many women have used telehealth — using technology to deliver healthcare services remotely — to bypass abortion bans. As of December 2023, telehealth constituted 19% of abortions in the U.S. healthcare system, according to the Society of Family Planning’s #WeCount project.

In June 2024, the U.S. Supreme Court unanimously ruled that a lawsuit challenging the FDA’s approval of mifepristone lacked standing, allowing the drug to remain widely available.

The number of abortions in the U.S. has grown in recent years partially due to the increased availability and use of the abortion pill, which accounted for 63% of abortions in 2023, according to a March 2024 study from the Guttmacher Institute.

FDA Commissioner Marty Makary notably said on April 24 that he has “no plans to take action” to limit the availability of mifepristone.

The study was written by the EPPC President Ryan T. Anderson and the EPPC Director of Data Analysis Jamie Bryan Hall.

Danco Laboratories did not respond to the Daily Caller News Foundation’s request for comment.

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