Systematic review demonstrates APR safety

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Dr. Joseph V. Turner et al. published a systematic review of the congenital and fetal effects after mifepristone exposure and continuation of pregnancy. This safety analysis is important for women who receive Abortion Pill Reversal treatment. This 10-page open access article has 2 figures, 2 tables, 57 references and one downloadable file containing database search strategies.

Abstract

Mifepristone is an anti-progestational drug that is the first component of the standard medical abortion regimen. For women who take mifepristone and then do not take misoprostol, which is the second component of the medical abortion regimen, it is possible that their pregnancy may continue to live birth. Since mifepristone is commonly used for medical abortion up to 9–10 weeks gestation, any adverse or teratogenic effects on the developing embryo/fetus must be considered, given exposure during the critical time of its development and organogenesis. Toxicology and teratology reports have cited studies demonstrating teratogenic effect of mifepristone in some animals. Current clinical guidelines for women exposed to mifepristone in the first trimester of pregnancy state that it is not known to be teratogenic based on limited published evidence from humans.

The aim of this narrative systematic review was to investigate embryonic/fetal exposure to mifepristone and any association with congenital or fetal anomalies. This study was conducted by systematic searches of health databases from inception to February 2024. The references of relevant citations were manually searched to retrieve any additional citations not captured in database searching. Congenital anomalies and adverse outcomes were encountered at various doses of mifepristone exposure. A number of the congenital anomalies encountered in this review were explained by circumstances other than exposure to mifepristone. The present systematic review did not find data to support mifepristone being implicated as a teratogen.

Study Highlights

What is the current knowledge on the topic? Mifepristone is teratogenic in some animals. Reports and guidelines vary on whether mifepristone has teratogenic potential in humans.

What questions did this study address? In ongoing pregnancies in which there is exposure of the embryo/fetus to mifepristone, is there an increase in the rate of congenital anomalies compared with the baseline rate in the general population?

What does this study add to our knowledge? The risk of congenital anomalies after mifepristone exposure in pregnancy does not appear to be increased over the baseline rate in the general population.

How might this change clinical pharmacological or translational science? Conclusions from this review lend support to existing clinical guidelines for women who take mifepristone for medical abortion but then proceed to having a viable pregnancy instead: that mifepristone is unlikely to cause congenital anomalies. This is becoming more important as the number of medical abortions using mifepristone grows and the number of women who receive Abortion Pill Reversal treatment increases.

Figure 1 Timeline of mifepristone exposure and fetal outcome

Additional Information Abortion Pill Reversal safety

For additional information on APR safety see https://aprscience.org/is-apr-therapy-unsafe-for-women/.

Citation

Turner, Joseph V., et al. “Congenital and Fetal Effects After Mifepristone Exposure and Continuation of Pregnancy: A Systematic Review.” Clinical Pharmacology & Therapeutics, July 2024, p. cpt.3392. DOI.org (Crossref), https://doi.org/10.1002/cpt.3392.

Attribution

The source of the content on this page is from Congenital and Fetal Effects After Mifepristone Exposure and Continuation of Pregnancy: A Systematic Review which was published using the Creative Commons 4.0 license. The authors were
Joseph V. Turner, Deborah Garratt, Anna Barwick, Lucas A. McLindon, M. Joy Spark, Angela Smith. No changes were made.

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