Searle sends a warning about misoprostol use
Searle sends a warning about misoprostol use
G.D. Searle & Co. in Skokie, IL, has sent a letter to health care providers warning that misoprostol (Cytotec) administration is contraindicated in pregnant women because it can cause abortion.
Misoprostol is indicated for the prevention of NSAID-induced gastric ulcers in patients at high risk of complications from gastric ulcer, as well as patients at high risk of developing gastric ulceration. It is not indicated for induction or labor or abortion. Searle’s letter states the uterotonic effect of misoprostol is a property of prostaglandin E1, of which misoprostol is a stable, orally active synthetic analog. It has been used as a cervical ripening agent prior to termination of pregnancy or for induction of labor in spite of specific contraindications to its use during pregnancy.
Serious adverse events reported following such off-label use 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 says it is unable to provide complete risk information for misoprostol because it has researched the topic and doesn’t plan to.
(Editor’s note: For details, call Searle at (800) 323-4204. The letter can be found at www.fda.gov/ medwatch/safety/2000/cytote.htm.)
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