FDA Approves Abortion Pill

B O S T O N, Sept. 27 -- The Food and Drug Administration todayapproved U.S. use of the abortion pill RU-486, a major victory forthose who battled for 12 years to bring the early-abortion methodto this country.

Proponents say the pill, which has been used by millions ofwomen in 13 countries, could transform abortion in the UnitedStates by making it more accessible and more private. But it can beused only in the earliest days of pregnancy.

It could be available to doctors within a month.

FDA Issues Some RestrictionsAnti-abortion organizations have fought to keep RU-486 out ofthe United States since the drug debuted in France in 1988. Theypledged to continue the fight.

To ensure the pill is used accurately and safely, the FDAmandated that women be given special brochures called “MedGuides”explaining who is eligible for a pill-caused abortion and what sideeffects to expect, and that they must make three trips to thedoctor to undergo the procedure.

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RU-486, now known by its chemical name mifepristone, can be usedonly within 49 days of the beginning of the woman’s last menstrualperiod. The woman takes three mifepristone pills. Two days later,she returns to the doctor to swallow a second drug, misoprostol,that causes uterine contractions to expel the embryo. She returnsfor a follow-up visit within two weeks to make sure the abortion iscomplete.

The FDA will allow mifepristone to be distributed only todoctors trained to accurately diagnose the duration of pregnancyand to detect ectopic, or tubal, pregnancies, because those womencannot receive mifepristone.

Also, the FDA restricted mifepristone’s use to doctors who canoperate in case a surgical abortion is needed to finish the job orin cases of severe bleeding — or to doctors who have made advancearrangements for a surgeon to provide such care to their patients.

To Be Marketed as MifeprexStudies show mifepristone is 92 percent to 95 percent effectivein causing early abortion, by blocking action of a hormoneessential for maintaining pregnancy. Without that hormone,progesterone, the uterine lining thins so an embryo cannot remainimplanted and grow.