Misoprostol label change welcomed by Obstetricians: revisions acknowledge off-label uses. (New Labor and Delivery Section).

Obstetricians are welcoming recent changes in the labeling for Cytotec that acknowledge the drug's off-label obstetric uses.

Cytotec (misoprostol) remains indicated solely for the prevention of gastric ulcers in people taking nonsteroidal anti-inflammatory drugs. But a previous contraindication for its use in pregnancy, which led some hospitals to forbid the use of Cytotec for obstetric purposes such as labor induction and cervical dilation, has been modified. The new label clarifies that the contraindication refers exclusively to the drug's approved indication: Pregnant women should not take Cytotec for the prevention of gastric ulcers. It does not contraindicate off-label uses related to the practice of obstetrics.

Indeed, the label now contains a new labor and delivery section that provides safety information related to the drug's unapproved use in cervical ripening and labor induction when administered vaginally, a practice that is widespread in the United States. The drug has also been used as an abortifacient.

Misoprostol's new labeling is a vast improvement over the previous version, but it remains "overly alarmist," said Dr. Charles Lockwood, chair of the American College of Obstetricians and Gynecologists Committee on Obstetric Practice.

"Ideally, I would have liked the new labeling to have stated that intravaginal Cytotec is safe and efficacious when employed for induction of labor and cervical ripening at the correct dosage and at the correct interval in the absence of absolute and relative contraindications," said Dr. Lockwood, professor and chair of obstetrics and gynecology at New York University, New York.

A spokesman for Searle, which manufactures the drug, said the company had been working with the Food and Drug Administration for more than 2 years on the label change. Searle has no plans to study Cytotec as a labor inducing agent or abortifacient and therefore cannot provide guidelines for these uses, he said.

But the label, which was revised in April, now provides information about risk factors associated with uterine rupture, which may guide safer use of the drug in pregnancy The label now lists the major adverse effects of Cytotec's obstetric uses, including hyperstimulation of the uterus, which may progress to uterine tetany with marked impairment of uteroplacental blood flow; uterine rupture ...