Minimize Risk When Using Misoprostol Off Label.

AMELIA ISLAND, FLA. -- The off-label use of misoprostol for the induction of labor is supported by good clinical evidence and the American College of Obstetricians and Gynecologists, Dr. B. Denise Raynor said at an ob.gyn. update sponsored by Emory University.

Following ACOG recommendations on obstetric use of misoprostol puts ob.gyns. in the best medicolegal position when using this agent, said Dr. Raynor of Emory University in Atlanta.

Misoprostol is licensed in the United States only for the prevention of gastric ulcers associated with the use of nonsteroidal anti-inflammatory drugs; it carries a warning against its use during pregnancy Still, the drug has been widely used off label for cervical ripening and labor induction.

In August of last year, Searle, the manufacturer of misoprosrol (Cytotec), sent a letter to health care providers reminding them that the drug is contraindicated in pregnancy and could result in serious adverse events, including maternal and fetal death.

A few months later, ACOG wrote a letter to the Food and Drug Administration in which it reaffirmed a previous committee opinion that misoprostol is safe and effective when used appropriately in pregnant women.

In that letter, ACOG recommended the following practices to minimize risk in patients who are undergoing cervical ripening or labor induction in the third trimester:

* Consider using 25 [micro]g for the initial dose.