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New Study Reveals Abortion Pill Complication Rate 22 Times Higher Than FDA Estimate

Analysis of over 865,000 mifepristone prescriptions shows nearly 11% of users experience serious adverse events, prompting calls for stricter FDA oversight.

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 by the Ethics and Public Policy Center analyzed insurance claims data from 2017 to 2023, covering over 865,000 mifepristone prescriptions.
  • The study found a 10.9% rate of serious complications, including hemorrhage, infection, sepsis, and follow-up surgeries, significantly higher than the FDA's reported rate of less than 0.5%.
  • Researchers argue that the FDA's data, based on clinical trials from 30,966 participants, does not reflect real-world conditions and excludes non-fatal complications.
  • The study urges the FDA to reinstate stricter safety protocols, including in-person visits, physician-only prescriptions, ultrasounds, and mandatory complication reporting.
  • FDA Commissioner Marty Makary has stated there are no immediate plans to alter current regulations but remains open to action based on data-driven evidence.