Off-Label Use of Misoprostol Called Safe For Cervical Ripening, Induction.

SARASOTA, FLA. -- Misoprostol is a safe and effective agent when used off label for both cervical ripening and labor induction, according to a recently published meta-analysis of 47 studies of the drug.

"It appears relatively safe for both mother and newborn and also results in a small reduction in the rate of cesarean sections compared to other induction agents, Dr. Luis Sanchez-Ramos, a coauthor of the study, said at a perinatal symposium sponsored by Symposia Medicus.

His comments came in the wake of a controversial letter that was sent in August by Searle, the manufacturer of misoprostol (Cytotec), to health care providers warning against use of the drug in pregnancy Misoprostol was approved by the Food and Drug Administration in 1988 solely for preventing and treating peptic ulcers.

Some critics have maintained that the letter was Searle's attempt to distance itself from the abortion controversy noting that it was issued shortly before the FDA approved mifepristone, which is used in conjunction with misoprostol to perform medical abortions.

Misoprostol became popular among obstetricians because of its effectiveness as both an abortifacient in early pregnancy and as a cervical ripening/labor inducing agent in later pregnancy In fact, the American College of Obstetricians and Gynecologists has issued committee opinions supporting the safety and efficacy of misoprostol use for early medical abortion and cervical ripening and labor induction.

The Searle letter includes a long list of possible adverse outcomes associated with misoprostol use in pregnancy including maternal or fetal death, uterine hyper-stimulation, uterine rupture or perforation, hysterectomy salpingo-oophorectomy, amniotic fluid embolism, severe vaginal bleeding, retained placenta, and shock.

The letter has led at least a handful of hospitals, fearing possible litigation, to pull misoprostol from their formulanes. But Dr. Sanchez-Ramos insisted the drug is safe. The letter "cites no evidence on which to base their claims, because there isn't any evidence," said Dr. Sanchez-Ramos, professor of maternal-fetal medicine at the University of Florida Health Science Center, Jacksonville.