Comment from American Academy of Medical Ethics
AnonymousSupportAdvocacy
Summary: The Evangelical Policy Project (EPP) argues that the FDA's safety data for mifepristone is inaccurate and calls for stricter safety protocols, including mandatory in-person physician visits. They advocate for the FDA to investigate the drug's harms and potentially reconsider its approval entirely.
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.
https://eppc.org/publication/insurance-data-reveals-one-in-ten-patients-experiences-a-serious-adverse-event/
Women deserve to know the true risk of serious adverse events and medical emergencies after using mifepristone – no matter how politically charged the discussion surrounding this drug. Such truly informed consent cannot occur without an in-person physician visit before a woman takes the drug. Direct, in-person medical supervision is necessary for women’s safety.