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Many obstetricians are using Cytotec, a drug known
to soften the cervix and cause uterine contractions that are more frequent
and powerful than normal labor.
Cytotec has not
been approved by the Food and Drug Administration (FDA) for use in pregnant
women.
The drug, made by G.D. Searle Corporation, is approved
only for treating peptic ulcers. Its package insert explicitly
warned that "Cytotec may cause the uterus
to rupture
(tear) during pregnancy if it is used to bring on (induce) labor."
Uterine rupture, the insert added, "may result in severe bleeding,
hospitalization, surgery, infertility, or death."
Since Cytotec was introduced in 1988, a growing
number of obstetricians have embraced it as a "miracle" drug
-- in spite of data that leave serious doubts about its safety. Lacking
FDA approval and scientific consensus on how to use it on pregnant women,
doctors have taken it upon themselves
to administer Cytotec to
their patients -- often without the women's informed consent.
Cytotec has now become "the predominant agent
of choice" for inducing labor, according to Dr. Charles Lockwood,
chairman of obstetrical practices for the American College of Obstetricians
and Gynecologists (ACOG).
The drug's appeal is twofold. Cytotec is much cheaper
to use than other drugs: A dose costs less than 25 cents, compared
with hundreds of dollars for other labor-inducing agents. It has also
enabled doctors to induce more
labors than ever before: Over the past decade, the induction
rate has doubled -- 1 in
5 women now has her
labor induced -- as doctors increasingly opt for additional medical intervention
in childbirth.
Doctors often rely on Cytotec for "convenience
inductions," using the drug to induce
labor during office hours rather than letting nature take its
course. Cytotec enables doctors to practice daylight obstetrics.
But studies highlight alarming risks associated
with Cytotec. The Cochrane Collaboration, an international body of independent
analysts and physicians that publishes widely respected assessments of
drug efficacy, cites numerous reports of
uterine rupture
and fetal distress involving
the drug.
Last year their report stated that "It cannot
be recommended for routine use at this stage." After another study
revealed a 28-fold increase in the risk of uterine rupture among women
with prior cesarean sections, ACOG issued guidelines in 1999 discouraging
the use of Cytotec in such cases. The organization continues to recommend
Cytotec for use in routine cases, however, insisting the drug is safe
at low doses.
With many doctors still regularly using Cytotec
to induce labor, the toll on pregnant women and their babies is mounting.
The FDA in the last three years alone, has received reports of 30
cases of uterine rupture in connection with the use of Cytotec,
and 8 cases
in which the fetus died in utero.
Mother
Jones, January/February
2001
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