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2w ago

New Study Reveals High Complication Rates for Abortion Pill Mifepristone

Analysis of insurance claims reports a 10.9% serious adverse event rate, significantly higher than the FDA's under-0.5% estimate, prompting renewed calls for stricter safety protocols.

A box of mifepristone pills on a robot outside the US Supreme Court in Washington, DC, US, on Tuesday, March 26, 2024. The court on Tuesday will hear oral arguments on whether to limit the use of mifepristone, one of two drugs most commonly used for abortions in the US. Photographer: Valerie Plesch/Bloomberg
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Overview

  • A large-scale study analyzed 865,727 mifepristone prescriptions between 2017 and 2023, uncovering a 10.9% rate of serious complications.
  • The reported complication rate is 22 times higher than the FDA's original estimate based on clinical trials of prescreened, generally healthy women.
  • The study highlights discrepancies between controlled trial data and real-world outcomes, emphasizing the need for updated safety monitoring.
  • Researchers recommend reinstating original FDA safety measures, including in-person visits, physician-only prescriptions, and mandatory adverse event reporting.
  • The Supreme Court has left open the possibility of future challenges to mifepristone's approval, maintaining legal uncertainty over its regulatory status.