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Searle
Warning Letter on the Misuse of Misoprostol in RU 486 Abortions
Source:
Fox News October 16, 2000
August
23, 2000
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
5200 Old Orchard Road
Skokie, Illinois, 60077
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