As justification for a Food and Drug Administration review of a drug used in medication abortion, two Trump administration health officials have referenced an April report from an anti-abortion group that claims to show a far higher rate of serious side effects from the drug than has been found previously. However, the report, which is not peer-reviewed research, didn’t disclose where it got its data and has substantial methodological issues, reproductive health experts say.
The drug in question, mifepristone, is used alongside misoprostol for medication abortion and is FDA-approved for terminating pregnancies through 10 weeks of gestation. As we have written before, serious side effects from medication abortion are rare.
Medication abortions make up most abortions in the U.S. — 63% of them in 2023, according to the Guttmacher Institute, a research organization that supports reproductive rights.
Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary have repeatedly promised an FDA review of mifepristone. In a May 14 Senate Health, Education, Labor & Pensions Committee hearing, Kennedy called the April report “alarming” and said that it “indicates that at very least the label should be changed” for the drug. Kennedy and Makary reiterated the promise of a review in a Sept. 19 letter, again citing the April report as reason for concern about the drug’s safety.

