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Betsy Hyde CNM
Branford, CT
New from G. D. Searle, manufacturer of Cytotec:
August 23, 2000
Re:Cytotec(R) (misoprostol)
IMPORTANT DRUG WARNING CONCERNING UNAPPROVED USE OF INTRAVAGINAL OR ORAL
MISOPROSTOL IN PREGNANT WOMEN FOR INDUCTION OF LABOR OR ABORTION
Dear Health Care Provider:
The purpose of this letter is to remind you that Cytotec administration by
any route is contraindicated in women who are pregnant because it can cause
abortion. Cytotec is not approved for the induction of labor or abortion.
Cytotec is indicated for the prevention of NSAID (nonsteroidal
anti-inflammatory drugs, including aspirin)-induced gastric ulcers in
patients at high risk of complications from gastric ulcer, e.g., the
elderly and patients with concomitant debilitating disease, as well as
patients at high risk of developing gastric ulceration, such as patients
with a history of ulcer.
The uterotonic effect of Cytotec is an inherent property of prostaglandin
E1(PGE1), of which Cytotec is stable, orally active, synthetic analog.
Searle has become aware of some instances where Cytotec, outside of its
approved indication, was used as a cervical ripening agent prior to
termination of pregnancy, or for induction of labor, in spite of the
specific contraindications to its use during pregnancy.
Serious adverse events reported following off-label use of Cytotec in
pregnant women include maternal or fetal death; uterine hyperstimulation,
rupture or perforation requiring uterine surgical repair, hysterectomy or
salpingo-oophorectomy; amniotic fluid embolism; severe vaginal bleeding,
retained placenta, shock, fetal bradycardia and pelvic pain.
Searle has not conducted research concerning the use of Cytotec for
cervical ripening prior to termination of pregnancy or for induction of
labor, nor does Searle intend to study or support these uses. Therefore,
Searle is unable to provide complete risk information for Cytotec when it
is used for such purposes.
In addition to the known and unknown acute risks to the mother and fetus,
the effect of Cytotec on the later growth, development and functional
maturation of
the child when Cytotec is used for induction of labor or cervical ripening
has not been established.
Searle promotes the use of Cytotec only for its approved indication.
Please read the enclosed updated complete Prescribing Information for Cytotec.
Further information may be obtained by calling 1-800-323-4204.
Michael Cullen, MD
Medical Director, U.S.
Searle
