The January 2011 issue of the Annals of Pharmacotherapy contains an important article – unfortunately not free ($25.00) – discussing the advent, workings, and possible effects of progesterone receptor modulators like mifepristone (RU-486) and ella (ulipristal). The article was written by Donna Harrison, M.D. (President, American Association of Pro-Life Obstetricians and Gynecologists) and James G. Mitroka,Ph.D. (Associate Professor of Pharmaceutical Sciences, Lloyd L Gregory School of Pharmacy, Palm Beach Atlantic University) and is entitled, “Defining Reality: The Potential Role of Pharmacists in Assessing the Impact of Progesterone Receptor Modulators and Misoprostol in Reproductive Health.” In part, the article is directed toward pharmacists who may see the adverse events associated with these drugs. Here is the abstract:
Medical abortion is increasingly heralded as an ideal method for decreasing maternal mortality in health-care resource-deprived areas and as an answer to the shrinking pool of physicians willing to perform abortions. The advent of progesterone receptor modulators (PRMs) and the recent approval by the Food and Drug Administration of ella (ulipristal) as an emergency contraceptive put pharmacists in the center of abortion controversy. Pharmacists, worldwide, need to be aware of the controversy surrounding the introduction of PRMs, particularly with regard to the effect on health policy, their mechanism of action, associated adverse events, and common off-label uses. Once understood, genuine opportunity exists for pharmacists to serve a fundamental role in positively shaping public health policy.
A key sentence in the article describes the potential abortifacient of ulipristal in humans:
Based on these data, it can be reasonably expected that the [FDA approved dose] will have an abortive effect on early pregnancy in humans.
And the possibility of embryological effect is noted as well:
Whether ulipristal is used intentionally or unintentionally by pregnant women, any surviving embryo may be exposed to an embryotoxic agent for >6 days, as the half-life of ulipristal acetate is approximately 32 hours.
The authors note that a fetal registry for ulipristal survivors needs to be established to track long term health defects in that there is a predictable 5% pregnancy rate for those who have taken the drug. Hopefully, more writing will be done with regard to these aspects of ulipristal and its abortifacient effects.