RU-486

In September of 2000, the U.S. FDA approved the use of RU-486 for the termination of early pregnancy, defined as 49 days or less, counting from the beginning of the last menstrual period. RU-486 is actually a combination of two pharmaceutical agents, mifepristone and misoprostol. Mifepristone, a synthetic steroidal antiprogestrerone, causes changes in the endometrium that interfere with a fertilized egg's ability to adhere to the lining of the uterus by decreasing HCG levels. Misoprostol is a prostaglandin that prompts uterine contractions. In combination, the two work by weakening the bond between the fertilized egg and the uterus and then expelling the embryo from the womb. Side effects include uterine cramping, bleeding, which in a small number of cases requires surgical treatment, nausea and fatigue, all of which may last from 5-10 days.

From a moral perspective, the use of RU-486 should be evaluated the same as any other abortion procedure. An abortion to terminate a viable pregnancy in its early stages preformed via a prescription drug in a physician's office or the privacy of one's own home is morally equivalent to a surgical abortion performed in a clinic or hospital. Any procedure whose sole immediate effect is the termination of a pregnancy before viability (or the directly intended destruction of a viable fetus) constitutes a direct abortion, which is strictly prohibited by Catholic moral teaching. In its moral context, this includes the interval between conception and implantation of the embryo (see the Ethical and Religious Directives for Catholic Health Care Services, n. 45).

Individually, however, mifepristone and misoprostol may have other uses that do not constitute a direct abortion and would be permissible for Catholic healthcare facilities to provide or to support. For example, misoprostol may be prescribed and administered as part of a procedure to evacuate fetal tissue following a spontaneous abortion (i.e., miscarriage) or in the treatment of ulcers associated with the use of non-steroidal anti-inflammatory drugs. Likewise, mifepristone (though currently only approved by the FDA for use as part of RU-486) has been the subject of many clinical studies looking at alternative therapeutic uses, such as part of treatment for endometriosis and fibroids, certain breast cancers, and ectopic pregnancy.

If mifepristone is approved by the FDA for any of these alternative clinical applications, then its use would need to be evaluated from the Catholic perspective on a case-by-case basis in light of the act's object, intention and circumstances and relevant moral principles, e.g., double effect. For example, while the use of mifepristone in the course of treatment for endometriosis could be considered morally licit according to an application of the principle of double effect, it is an open question as to whether its combined use with methotrexate in response to ectopic pregnancy would meet the criteria of double effect. If, for instance, the direct effect of the mifepristone in this case is to weaken the pathological bond between the trophoblast and the fallopian tube so that the methotrexate can dissolve that bond more effectively (as some studies suggest), then one might argue that it would be licit to use it with this direct intention even though the decrease in HCG levels would also, either concomitantly or subsequently, lead to the death of other cells and, ultimately, of the embryo itself. This analysis depends primarily on whether one can be morally certain that the death of the embryo is only an indirect effect of the mifepristone and not the mechanism by which it functions, in which case the double effect analysis would not hold. For further discussion on the use of methotrexate in resolving ectopic pregnancies, see Abortion, and Kevin O'Rourke, OP, "Applying the Directives: The Ethical and Religious Directives Concerning Three Medical Situations Require Some Elucidation." Health Progress 79, 4 (July-August 1998): 64-69.

[Sources: Perdu, M., Camus, E., Rozenberg, P. et al., "Treating Ectopic Pregnancy with the Combination of Mifepristone and methotrexate: A Phase II Nonrandomized Study," American Journal of Obstetrics and Gynecology 179 (1998): 640-43; F. Cadepond, A. Ulmann, and E. Baulieu, "RU486 (Mifepristone): Mechanisms of Action and Clinical Uses," Annual Review of Medicine 48 (1997): 129-56; HHS Press Release, "FDA Approves Mifepristone for the Termination of Early Pregnancy," available at: http://www.fda.gov/bbs/topics/NEWS/NEW00737.html; CNN, "Food and Drug Administration Approves 'Abortion Pill', available at: http://www.cnn.com/2000/HEALTH/women/09/28/abortion.pill/]

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