Comment from Mary Kirchoff
AnonymousSupportAcademic
Summary: The American College of Obstetricians and Gynecologists argues that the real-world rate of serious adverse events from mifepristone is significantly higher than reported in clinical trials. They urge the FDA to reinstate stricter patient safety protocols, mandate full side-effect reporting, and reconsider the drug's approval based on these safety concerns.
This largest-known study of the abortion pill is based on analysis of data from an all-payer insurance claims database that includes 865,727 prescribed mifepristone abortions from 2017 to 2023.
10.93 percent of women experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion.
The real-world rate of serious adverse events following mifepristone abortions 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.
The FDA should immediately reinstate its earlier, stronger patient safety protocols to ensure physician responsibility for women who take mifepristone under their care, as well as mandate full reporting of its side effects.
The FDA should further investigate the harm mifepristone causes to women and, based on objective safety criteria, reconsider its approval altogether.