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RU-486 Slated for Approval by Year's End, Sources Say

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WebMD Health News

Nov. 18, 1999 (Chicago) -- Sources at a scientific meeting here tell WebMD that mifepristone, the abortion drug known as RU-486, will be approved for use in the U.S. before the end of the year. The FDA granted mifepristone an "approvable" letter in 1996, pending the resolution of certain manufacturing issues. Abortion foes have tried to keep the drug off the market.

The Population Council, which holds the rights to make and market mifepristone in the U.S., confirms that the approval of RU-486 is imminent. Christina Horzepa, public information specialist for the organization, tells WebMD that the FDA has been working with the Danco Group of New York on production and distribution issues associated with the controversial product. Danco is the licensee designated by the Population Council to manufacture RU-486.

RU-486 is available in Europe, but an FDA spokesman declined to comment on reports about the pending approval. Mifepristone is taken early in pregnancy then followed by the companion drug misoprostol two days later. That combination triggers a chemical abortion.

Advocates say mifepristone will allow women to have abortions safely and in private without having to face possible harassment by opponents of the procedure at an abortion clinic. Still, under the current protocol, a woman using RU-486 would have to visit the doctor three times during the procedure. The drug won't be available at pharmacies, but only from physician providers.

However, research presented here at the 127th Annual Meeting of the American Public Health Association suggests that women might be able to take RU-486 without a doctor's supervision. Reviewing the data from a trial of more than 2,000 U.S. women who used mifepristone, demographer Cynthia Harper, PhD of the University of California, San Francisco, says home use could be possible.

"The most simple it could get is that women would be in charge of it, and probably the most supervised it could get is the regimen that was followed in this trial," Harper tells WebMD. Among the issues, says Harper, is how quickly women could determine they were pregnant since delays were associated with more side effects. Patients would also have to cope with the expulsion of the embryo on their own.

Virtually every woman in the study had some severe side effects from the treatment, including nausea, vomiting, and abdominal pain. Harper says 75% of these women would require prescription pain relief. Another problem is that after taking RU-486, many women started their abortion on the way the clinic.

In order for home use of mifepristone to succeed, Harper says it's crucial to have an emergency plan, a 24-hour on-call provider and guidelines about how much bleeding is acceptable. Still, with all of the caveats, Harper found the most of the women were comfortable with going through part or all of the procedure at home.

Another study from the Population Council shows that use of the drug misoprostol alone might be an effective abortion drug, particularly in countries where getting a surgical abortion poses a higher risk. Misoprostol, a widely used ulcer treatment, is available in 60 countries. Using this approach on 157 women in Vietnam and India, shows that misoprostol can end an early pregnancy up to 60% of the time, thus reducing the need for surgery by about half.

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