Fact Check: More than one out of ten women experience serious adverse events from mifepristone.

Fact Check: "More than one out of ten women experience serious adverse events from mifepristone."

What We Know

The claim that "more than one out of ten women experience serious adverse events from mifepristone" suggests that the incidence of severe complications following the use of this medication for medical abortion is over 10%. A comprehensive analysis of data from Planned Parenthood affiliates covering 2009 and 2010 indicates that significant adverse events occurred in only 0.65% of cases, with serious adverse events specifically reported in 0.16% of medical abortions performed during that time (Significant Adverse Events and Outcomes After Medical Abortion).

Additionally, a more recent study analyzing adverse events reported to the FDA from September 2000 to February 2019 found that while there were significant morbidity and mortality events associated with mifepristone, the overall rates of severe complications were not as high as claimed. The study indicated that the FDA's adverse event reporting system significantly underestimates the actual number of adverse events but did not provide a rate exceeding 10% for serious complications (Deaths and Severe Adverse Events after the use of mifepristone).

Analysis

The claim appears to stem from a more recent analysis that reported 10.93% of women experiencing serious adverse events, including sepsis and hemorrhaging, within 45 days following a mifepristone abortion (The Abortion Pill Harms Women). However, this analysis relies on data from an all-payer insurance claims database, which may not comprehensively capture all adverse events or the context in which they occurred.

In contrast, the studies conducted by Planned Parenthood, which are based on a large dataset and have been peer-reviewed, indicate that serious adverse events are much less common than the claim suggests. The Planned Parenthood study's methodology included rigorous follow-up and reporting protocols, which lend credibility to its findings (Significant Adverse Events and Outcomes After Medical Abortion).

Moreover, the FDA's own reports and analyses have not corroborated the claim of over 10% serious adverse events, suggesting that the higher figure may be an outlier or misinterpretation of the data (Mifepristone US Post-Marketing Adverse Events).

The reliability of the sources is crucial in this context. The Planned Parenthood study is a well-established and peer-reviewed source, while the claim's supporting study relies on insurance data that may not be as rigorously validated. Furthermore, the FDA has acknowledged that its adverse event reporting system is inadequate and may underreport complications, but this does not imply that the rate of serious adverse events is as high as claimed (Deaths and Severe Adverse Events after the use of mifepristone).

Conclusion

The claim that "more than one out of ten women experience serious adverse events from mifepristone" is False. The evidence from reputable studies indicates that serious adverse events occur in significantly fewer than 10% of cases, with rates reported at approximately 0.16% for serious complications. The higher figures cited in some analyses do not align with the broader, peer-reviewed data available on the safety of mifepristone.

Sources

1. Significant Adverse Events and Outcomes After Medical Abortion
2. Deaths and Severe Adverse Events after the use of mifepristone
3. Mifepristone US Post-Marketing Adverse Events
4. Daines Statement on New Study Showing Alarming Effects of Abortion Pill
5. Mifepristone U.S. Post-Marketing Adverse Events Summary
6. Fact checking a study on the safety of the abortion pill
7. Risks of and Indications for Mifepristone for Medication Abortion
8. The Abortion Pill Harms Women: Insurance Data Reveals One in Ten Patients Experiences a Serious Adverse Event