Abortion Drug Approved By Fda Panel But Doctors Also Warn Of Risks; Final Decision Still Months Away

Scientific advisers recommended Friday, with some conditions, that the controversial drug RU-486 become the first approved alternative to surgery for American women who have abortions.

The decision puts the French drug, which has been taken by 200,000 European women since 1988, a step closer to U.S. doctors’ offices - but it came with certain caveats.

The scientists warned 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 in Pasadena, Calif.

Still, as abortion foes protested, the advisers voted 6-0 with two abstentions that RU-486’s benefits outweigh its risks, a recommendation that the Food and Drug Administration approve the drug.

If final analysis of a study on 2,100 American women, not yet complete, turns out differently from the French data on which the panelists based the decision, they get a chance to review the research again.

Abortion foes had urged the FDA’s advisers to reject the drug, saying it endangered not just fetuses but mothers. But research on thousands of French women showed RU-486 causes an abortion 95.5 percent of the time, with rare complications.

The FDA is not bound by advisory panel decisions but usually follows them. FDA Commissioner David Kessler said he hoped to make a decision on RU-486 within two months, but would not say which way he is leaning. “It’s fair to say there were certain strong and intense feelings” expressed on RU-486, but “the scientific portions of this meeting were no different today than at any other advisory committee.”

One panelist, who abstained from the vote, agreed with anti-abortion groups.

The drug may benefit women “but it’s certainly no benefit to her baby whatsoever,” said Dr. Mary Jo O’Sullivan of the University of Miami.

“RU-486 is a human pesticide,” said Rebecca Lindstedt of the American Life League.

Outside the hearing, blocked by a line of police cars, a handful of protesters picketed with signs reading “Stop Abortion Now.”

Countered Dr. Elizabeth Newhall, who tested RU-486 on 176 Oregon women as part of trials by the nonprofit Population Council: “Abortion is not on trial here. A drug that offers a safe and effective alternative is.”

RU-486, known chemically as mifepristone, is 95.5 percent effective when used in the earliest weeks of pregnancy - 49 days from conception, according to studies of 2,480 French women.

MEMO: This sidebar appeared with the story: THE PILL VS. SURGERY According to the Population Council, the advantages of the abortion pill over surgical abortion, include: It requires no surgery or general anesthesia. It can be used with greater privacy. Some women feel it gives them more control over their bodies. The advantages of surgical abortion include: It requires fewer office visits and is over more quickly. (The abortion pill requires three visits for administration and follow-up.) The loss of blood is less noticeable than with RU-486. Associated Press