A new report by the Ethics and Public Policy Center has raised significant concerns about the safety of the abortion pill, mifepristone, showing that nearly one in ten women experience serious adverse events after taking the drug.

This analysis, based on a large-scale study of 865,727 mifepristone abortions between 2017 and 2023, uncovers troubling data that calls into question the safety assurances surrounding the drug.

The report reveals that 10.93% of women experienced life-threatening complications, including sepsis, hemorrhaging, or infections, within 45 days of taking mifepristone. This figure is starkly different from the “less than 0.5%” adverse event rate reported in the clinical trials that supported the drug’s approval.

The findings highlight a significant gap between clinical trial data and real-world outcomes, raising urgent questions about the reliability of the current safety protocols for mifepristone. The Ethics and Public Policy Center calls for immediate action from the FDA to reinstate stricter safety measures for prescribing mifepristone and to require more comprehensive reporting of adverse events.

The study also stresses the importance of revisiting the approval process for mifepristone, urging the FDA to consider these real-world safety concerns in its ongoing assessment of the drug.

For more details on the findings and the potential policy implications, read more here.