Published 11 months ago • loading... • Updated 10 months ago
Federal Agencies Open Investigation Into the Safety of Abortion Drug Mifepristone ✅
The FDA review follows pressure from 22 Republican-led states amid disputes over mifepristone’s safety, used in nearly two-thirds of U.S. abortions, officials said.
Last week, Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary announced the FDA will conduct its own review of the evidence on mifepristone's safety and efficacy.
By citing a non-peer-reviewed EPPC analysis, critics urged restoring REMS and 2011-era safety regulations after nearly 11% reported serious adverse events versus the FDA's 0.5% rate.
The FDA says mifepristone is safe when used as directed, reporting 36 deaths through Dec. 31, 2024, and noting five deaths per 1 million users since its 2000 approval and 2016 extension.
Reimposing REMS would likely end teleprescribing and mailing, which now account for more than 60% of abortions and affect patients in states with abortion bans.
Medical groups countered that mifepristone is safe, with Mini Timmaraju saying it is 'safe, effective, and essential' while Kiki Freedman warned the review could 'undermine access' and called it politically motivated.