Women Deserve Better

Recently, a study was released by Jamie Bryan Hall and Ryan T. Anderson of the Ethics and Public Policy Center concerning the safety of mifepristone which is a one of two medications used for medical abortions in the United States. Mifepristone is a compound that binds with high affinity to progesterone receptors in the human body thus blocking natural progesterone from binding to the receptors and leading to fetal demise because progesterone is needed for fetal development. The second drug administered 24-48 hours after taking mifepristone is misoprostol which causes cervical softening and uterine contractions resulting in expulsion of the products of conception. In 2000, during the Clinton Administration, the FDA approved mifepristone for medical abortions after small clinical trials (859 U.S. participants) under a strict Risk Evaluation and Mitigation Strategy (REMS) that required three IN-PERSON office visits, physician only prescribing, only in-clinic administration of medications, mandatory reporting of ALL serious adverse events, and physicians had to be able to quickly access surgical and emergency care. In 2016, during the Obama Administration, REMS was relaxed – in-person visits lowered from three to one, extension of gestational limit from 7 to 10 weeks, in-office administration of medication was removed, and adverse event reporting was no longer required except under specific circumstances. In 2023, during the Biden Administration, REMS was lowered even further – no in-person visits required and telehealth permitted, mail order pharmacies allowed to dispense abortion medication, non-physician healthcare providers permitted to prescribe, and the only adverse event required to be reported is death. The Hall/Anderson study was a review of insurance claims made within 45 days following 865,727 mifepristone abortions performed during 2017-2023. Examination of the insurance data showed an alarming number of serious adverse event claims – hemorrhage, emergency room visit related to the abortion, repeated surgical abortion, infection, abortion related hospitalization, ectopic pregnancy, transfusion, sepsis, and several other emergency events – of 10.93%. The FDA drug label for mifepristone reports the serious adverse event rate as < 0.5% based on the small scale clinical research done in a tightly controlled environment for the 2000 drug approval. We now have large scale, real world data indicating that mifepristone is not as safe as is being touted by the abortion industry. Additionally, a medication with a 10% risk of a serious adverse event is being sold with no in-person office visit or in-person post medical procedure follow up. An absolute recipe for disaster. The FDA should pull mifepristone from the market.

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