Health and Human Services Secretary Robert F. Kennedy Jr. has directed the FDA to conduct a safety review of mifepristone, a medication commonly used for abortions in the U.S. This decision follows an “alarming” report indicating a significantly higher rate of serious complications associated with the drug than previously reported. The report claims a 22-fold increase in serious adverse events, suggesting a re-evaluation of mifepristone’s safety profile and potential changes to its labeling. Released by the conservative Ethics and Public Policy Center, the report has drawn criticism for lacking peer review and relying on questionable data sources.
Despite existing research indicating that less than 0.5% of women experience serious adverse reactions to mifepristone, the report asserts the number could be as high as 11%. Critics, including reproductive health researchers, denounce the report as “junk science” and argue that its broad definitions of “serious adverse events” incorrectly categorize minor side effects and certain medical conditions unrelated to the medication. The report claims to be based on 865,727 insurance claims but fails to clarify its database.
Experts like Dr. Ushma Upadhyay and Rachel Jones emphasize that FDA policy should be based on rigorous clinical research, not ideologically driven analyses. Advocates for limiting abortion access view the report as an opportunity to call for stricter regulations on mifepristone.
Kennedy has stated that the decision to review mifepristone’s safety may ultimately be influenced by the White House under President Trump. This situation reflects a broader strategy by anti-abortion groups to challenge mifepristone’s approval through various means, including releasing dubious studies and pursuing legal avenues.
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