Abortion pill is approved for sale in United States
Amid bitter opposition from
antiabortion groups, federal
authorities announced that the
abortion pill RU-486 has been
approved for sale in the United
States. The pill should be available there within four to six
weeks, according to Planned
Parenthood.
The Food and Drug Administration (FDA) approved RU-486 (mifepristone) for the
termination of early pregnancy,
defined as 49 days or less, counting from the beginning of the
last menstrual period. The
administration said it based its
approval of mifepristone on
data about safety and effectiveness from clinical trials in the
United States and France. It is
estimated that more than half a
million women in Europe have
used mifepristone since its debut
in France 12 years ago.
Representative Helen Chenoweth-Hage, and other Republican members of Congress opposed to the use of the abortion pill, speak to the press in Washington after the FDA announcement (AP PHOTO/KAMENKO PAJIC)
Supporters lauded the
approval as a milestone, making
abortion more private and
improvingaccess for womenliving
in areas where surgical abortions
are not available. Antiabortion
organisations, which have fought
since 1988 to keep RU-486 out of
the United States, assert that the
pill carries health risks for women.
The FDA's announcement has
prompted a flurry of statements
from politicians and organisations
on both sides of the issue.
Texas governor and Republican presidential candidate
George W Bush called the decision wrong, saying: "I fear that
making this abortion pill widespread will make abortions
more and more common... . As
president, I will work to build a
culture that respects life."
Vice President and Democratic presidential candidate Al
Gore agreed with the FDA.
"Today's decision is not about
politics," he said, "but the health
and safety of American women
and a woman's fundamental
right to choose."
The National Right to Life
Committee vowed to fight RU-
486 through educational
efforts. Spokeswoman Laura
Echevarria said that the organisation would make sure
"women know about the development of their unborn child,
that about the time an RU-486
abortion takes place, an unborn
child's heart has most likely
begun to beat."
Mifepristone works by causing the embryo to detach from
the uterine lining. To induce an
abortion, the drug is taken with
misoprostol, which causes contractions and aids in expelling
the embryo. Under the
approved regimen, a woman
first takes three mifepristone
pills by mouth. Two days later,
she returns to the doctor to take
the second drug. She returns for
a follow up visit within two
weeks to make sure the abortion
is complete.
Under the terms of the
approval, mifepristone will be
distributed to physicians who
have access to ultrasonography
to determine the duration of a
patient's pregnancy and detect
an ectopic pregnancy, which is a
contraindication for use of RU-486. Physicians who prescribe
mifepristone must also be able to
provide surgical intervention in
cases of incomplete abortion or
severe bleeding, the FDA said, or
they must have made plans in
advance to provide such care
through others. In about one of
100 women, bleeding can be so
heavy that a surgical procedure
will be required to stop it.
Advocates and opponents
say the abortion pill's impact
could be muted by trepidation
among doctors about prescribing the controversial drug.
Scott Gottlieb, New York
studentBMJ 2000;08:395-434 November ISSN 0966-6494
