Serious Harms to Women from the Abortion Pill

A new study from my colleagues at EPPC shows real world rates of serious adverse effects of Mifepristone are much higher than previously reported to the FDA.

My colleagues Jamie Hall and Ryan Anderson at the Ethics and Public Policy Center just published a shocking study of the abortion pill mifepristone. The largest study yet of its kind, it reveals serious safety problems which were previously underreported. The study based on analysis of data from an all-payer insurance claims database that includes 865,727 prescribed mifepristone abortions from 2017 to 2023.

The key finding is that within 45 days of taking the chemical abortion pill, almost 11% of women experience serious adverse event such as sepsis, infection, or hemorrhaging. This is 22 times the rate originally reported (0.5%) in the clinical trials submitted to the FDA, suggesting that this pill is much less safe than women have been led to believe.

Real world data can sometimes differ from the findings of highly controlled and selective clinical trials, for example, if the patient selection criteria in clinical practice is less stringent than the controlled experimental conditions of a clinical trial. This could account, in part, for the much higher rates of serious side effects in this study as compared to the data the FDA previously examined, which was submitted by the drug’s manufacturer during the approval process. Furthermore, during the previous two administrations, the FDA relaxed the safety protocols for mifepristone, which may also contribute to these findings, as summarized here:

In light of this study’s findings, the authors call on the FDA to reinstate its earlier, more robust patient safety protocols, including an ultrasound for dating the pregnancy and an in-person examination. Many patients obtain mifepristone through the mail through “telemedicine” apps that require little more than a few clicks and virtually no evaluation. The pill is then shipped across state lines, making it almost impossible for states to regulate or monitor its use. Fierce debates about abortion in our society often prevent objective analysis of data on the topic; however, given that chemical abortions now account for two-thirds of all abortions, these findings deserve close scrutiny and attention.

The authors also propose that healthcare providers should be required once again to report to the FDA (and manufacturers of mifepristone) all serious adverse effects on women resulting from the use of the drug. This study can easily be replicated by widely available databases, including the government’s own VA Hospital and Tricare insurance databases for military personnel. The FDA should further investigate the harm mifepristone causes to women and, based on objective safety criteria, reconsider its approval altogether.

Along with the study’s two authors, I will be sending this data and an accompanying letter to FDA Commissioner Marty Makary and HHS Secretary Robert F. Kennedy Jr. this week. You can read the full study here.

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