FDA Commissioner Marty Makary confirmed that he will review the safety of the abortion drug mifepristone after a study revealed troubling adverse health outcomes exceeding the risks reported on its label.
“As the Commissioner of Food and Drugs, I am committed to conducting a review of mifepristone and working with the professional career scientists at the Agency who review this data,” Makary wrote to Sen. Josh Hawley (R-MO). “Mifepristone for medical termination of early pregnancy is the subject of pending litigation. FDA generally does not comment on matters that are the subject of pending litigation and therefore is unable to provide further information on this topic at this time.”
Hawley previously asked HHS Secretary Robert F. Kennedy Jr. about the pill, saying, “You have said you will do a top-to-bottom review. Do you continue to stand by that, and don’t you think that this new data shows the need to do a review is in fact very pressing?”
“It’s alarming,” Kennedy responded. “Clearly, it indicates that at the very least, the label should be changed. I’ve asked Marty Makary, who is the director of the FDA, to do a complete review and to report back.”
The study found that nearly 11% of women have an adverse reaction to the pill.
The think tank behind the study, the Ethics and Public Policy Center, described it as the “largest-known study of the abortion pill,” and found that “10.93 percent of women experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion.” It explained that the “real-world” rate of the serious adverse events is “at least 22 times as high as the summary figure of ‘less than 0.5 percent’ in clinical trials reported on the drug label.”
