MEDICATIONS: CYTOTEC GIVEN ORALLY FOUND SAFE AND EFFECTIVE TO INDUCE LABOR

June 3, 2002 — Giving Cytotec® (misoprostol) orally to induce labor is as safe and effective as giving the pill vaginally, according to a study published in the June issue of Obstetrics & Gynecology. Researchers at Texas Tech University Health Sciences Center in El Paso conducted a randomized trial to compare the safety and efficacy of vaginal misoprostol with oral misoprostol for inducing labor. One group of women received one or more doses of oral misoprostol and the other group received one or more doses of misoprostol inserted vaginally. There was little difference between the two groups in delivery time, cesarean delivery rate, neonatal outcomes, or the number of doses of misoprostol needed to induce labor. Women who received oral misoprostol who were having their first baby were twice as likely to need vacuum- or forceps-assisted deliveries than women receiving oral misoprostol had had previous deliveries. The dosage of misoprostol needed to induce labor was higher with oral administration (100 ug) than with vaginal administration (25 ug). According to the researchers, their findings suggest that in a closely supervised hospital setting with adequate monitoring, oral misoprostol has the potential to induce labor as safely and effectively as vaginal misoprostol. This is important, they say, since some women resist the digital exams that are necessary for the placement of misoprostol into the vagina.

NOTE: On April 17, 2002, the FDA announced a revision in the drug labeling of Pharmacia's drug, Cytotec. The label change acknowledges the widespread off-label use of Cytotec by obstetricians for cervical ripening to induce labor and removes the previous contraindication for use in pregnant women for this purpose.