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FDA is told abortion pill okay

Published Sep. 16, 2005

American women likely will have access to an abortion pill by next year.

Scientific advisers recommended Friday that RU-486 become the first approved U.S. alternative to abortion surgery. The decision puts the French drug a step closer to U.S. doctors' offices.

But the recommendation came with certain caveats.

The scientists warn that women must understand RU-486 can be painful, cause bleeding and must be used carefully _ requiring three separate doctor exams.

"The term "safe' should not be misinterpreted as free of adverse events, and serious adverse events," said Dr. Diana Petitti of Kaiser Permanente Medical Care Program.

Still, as abortion foes protested, the advisers voted 6-0 with two abstentions that RU-486's benefits outweigh its risks.

The recommendation to the Food and Drug Administration: Approve the drug.

If final analysis of a study on 2,100 U.S. women turns out different from the French data on which the panelists based the decision, they get a chance to review the research again.

Research on thousands of French women showed RU-486 causes an abortion 95.5 percent of the time, with rare complications.

The FDA has promised to reach a decision on whether to approve the drug _ already available in France, England and Sweden _ by September. While the agency is not bound to follow the advice of the advisory panel, it usually does.

"This is potentially a historic time for American women," said Gloria Feldt, president of the Planned Parenthood Federation of America.

"It enables a woman to terminate a pregnancy earlier and without surgery and without anesthesia."

Critics fear RU-486 will be used for emergency contraception and lead to greater sexual irresponsibility.

How the pill works

The abortion pill blocks the action of the hormone that prepares the uterus for pregnancy. Two days after taking the pill, the woman takes two tablets of prostaglandin, which causes the uterus to contract, causing a miscarriage.