FDA Report Shows Abortion Pill May be Dangerous, Misused
April 17, 2002
Washington, DC -- A 21-year-old woman had a heart attack
three days after using the dangerous abortion pill mifepristone, but there is no
way to know if the pill played a role, health officials said Wednesday.
In a letter to doctors, the pill's distributor also said
two women had serious infections after using the abortion pill - one of whom was
a Canadian woman reported by doctors last fall to have died.
Again, there is no way to know if mifepristone had a role,
the Food and Drug Administration said in a fact sheet posted on its Internet
site Wednesday.
But the FDA ordered the reports released for another
reason: concern that doctors were giving the abortion pill to some women with
ectopic pregnancies - something they are not supposed to do. The agency has
three reports of ruptured tubal pregnancies among mifepristone users, one of
whom died.
Ectopic, or tubal, pregnancies are potentially
life-threatening situations where a human embryo lodges outside the woman's
uterus.
While the abortion pill will not have any effect on an
ectopic pregnancy, the concern is that a woman with the kind of pain that
signals a life-threatening rupture might attribute the pain to the abortion pill
and delay seeking care.
Doctors are supposed to rule out ectopic pregnancies before
prescribing the abortion pill, but they can be hard to diagnose.
``This is a reminder to clinicians and women to be alert to
the risk of ectopic pregnancy,'' said FDA drug chief Dr. Janet Woodcock. The FDA
approved use of the dangeorus abortion pill in September 2000.
Mifepristone's distributor, Danco Laboratories, claimed the
six reports were an ``extremely small incidence'' of problems. It refused to say
how many women have used the abortion pill in its 17 months on the market.
Mifepristone blocks the action of a hormone vital for an
embryo to develop. Women then must use a second drug, misoprostol that causes
contractions to then expel the dead unborn child. The process only works in the
first seven weeks of pregnancy.
The FDA Question and Answer document is available at:
http://www.fda.gov/cder/drug/infopage/mifepristone/mifepristone-qa_4_17_02.htm
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