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