US approves controversial abortion pill

WASHINGTON - United States health officials approved the abortion pill RU-486 on Thursday, clearing the way for its sale after 12 years of political battles and delays that kept it off the US market.

The pill, also known as mifepristone, can induce an abortion early in pregnancy without surgery. The drug debuted in France in 1988, but abortion opponents fought its entry into the US.

The drug will be sold under the brand name Mifeprex by Danco Laboratories, a private firm that was set up to distribute and market the product. The intense US abortion debate kept big drug makers from pursuing the pill. The current manufacturer has been kept secret.

Mifepristone should be available in about one month, according to The Population Council, the New York-based nonprofit group that owns US rights to the pill.

``American women now will have access to this non-surgical method as do women in France, the United Kingdom, Sweden and other countries in Europe,'' Population Council spokeswoman Sandra Waldman said.

Mifepristone causes an abortion by blocking a hormone needed to sustain pregnancy. Under the regimen approved by the Food and Drug Administration, mifepristone would be followed two days later by misoprostol, a medication that causes uterine contractions.

Women need to return to their doctors two weeks later to find out whether the pregnancy has been terminated. The drug combination works in about 95 percent of cases.

The FDA approved the pill for use during the first 49 days after a woman's last menstrual period. Women who receive the drug will be given a pamphlet that explains how to use it and cautions about possible side effects such as severe bleeding.

The approval ``is the result of the FDA's careful evaluation of the scientific evidence related to the safe and effective use of this drug,'' FDA Commissioner Jane Henney said.

Abortion rights groups cheered the news after years of obstacles. Former President George Bush banned RU-486 from the country in 1989. President Clinton lifted the ban in 1993, and French maker Roussel-Uclaf donated rights to the Population Council in 1994. An advisory panel recommended approval in 1996, but the Population Council had trouble working out manufacturing and distribution.

The final approval is a ``total victory for U.S. women. At long last, science trumps anti-abortion politics,'' said Eleanor Smeal, president of the Feminist Majority Foundation.

With mifepristone, women and doctors may have more privacy from protesters and access to abortion may widen, particularly in rural areas where there are no clinics, supporters said.

``The Clinton-Gore administration, which claimed it wanted to make abortion rare, has embraced an abortion pill that will result in more abortions and new risks to women,'' said Laura Echevarria, a spokeswoman for the National Right to Life Committee.

Passion against abortion is so high that clinics have been bombed, and doctors and clinic workers have been harassed and killed. Concerned about possible retaliation, the FDA was keeping the names of the scientists who reviewed the drug secret, Henney said.

Mifepristone has some safety risks, which opponents plan to highlight in order to discourage the pill's use. Possible side effects include nausea, vomiting and bleeding. In rare cases, bleeding was so severe that patients needed blood transfusions.

Doctors who prescribe mifepristone must be able to determine how long a woman has been pregnant and whether they may have a tubal pregnancy, the FDA statement said.

Also, prescribers must have plans for how to provide surgical procedures in cases of severe bleeding or an incomplete abortion, the FDA said.

- REUTERS