NurseWeek

Abortion pill receives FDA's approval

By Bradford G. Brokaw
September 29, 2000


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Washington (H24N). The first legal alternative to surgical abortion yesterday received approval from the Food and Drug Administration (FDA) when it approved the use of the abortion pill RU-486. Advocates of the drug have tried for 12 years to bring the early-abortion method to this country.

The drug allows women to terminate pregnancy within seven weeks of their last menstrual period. It has been sold in Europe and elsewhere in the world for more than a decade, and an FDA advisory committee had already recommended approving the drug for this country.

Proponents say the pill, which has been used by millions of women in 13 countries, could transform abortion in the United States by making it more accessible and more private.

Opponents of legal abortion have urged that the drug not be sold in the United States. They say it is more dangerous than surgical abortions, causing severe bleeding in about 2 percent of women and incomplete abortions in 5 to 8 percent, requiring that the women have surgical abortions to complete the procedure.

The drug's maker, the Roussel Ucalf unit of Hoechst A.G., declined to seek marketing approval for it in the United States, saying it feared protests from opponents of abortion rights.

In 1994, the company gave the drug's patent to a nonprofit group, the Population Council, which set out to get market approval.

An FDA advisory committee recommended four years ago that the drug be approved, and the agency, under its former commissioner, David A. Kessler, Ph.D., wrote to the Population Council saying the drug could be approved if certain conditions were met. But the council has had difficulty finding a company to make the drug and one to market it.

To ensure the pill is used accurately and safely, the FDA mandated that women be given special brochures called ''MedGuides,'' explaining who is eligible for a pill-induced abortion and what side effects to expect, and that they must make three trips to the doctor to undergo the procedure.

RU-486, now known by its chemical name mifepristone, can be used only within 49 days of the beginning of the woman's last menstrual period. The regimen requires the woman to take three mifepristone pills. Two days later, she returns to the doctor to take a second drug, misoprostol, which causes uterine contractions to expel the embryo. She returns for a follow-up visit within two weeks to make sure the abortion is complete.