The drug, made by G.D. Searle Corporation, is approved only for treating peptic ulcers. Its package insert explicitly warned that "Cytotec may cause the uterus to rupture (tear) during pregnancy if it is used to bring on (induce) labor." Uterine rupture, the insert added, "may result in severe bleeding, hospitalization, surgery, infertility, or death."

Since Cytotec was introduced in 1988, a growing number of obstetricians have embraced it as a "miracle" drug -- in spite of data that leave serious doubts about its safety. Lacking FDA approval and scientific consensus on how to use it on pregnant women, doctors have taken it upon themselves to administer Cytotec to their patients -- often without the women's informed consent.

Cytotec has now become "the predominant agent of choice" for inducing labor, according to Dr. Charles Lockwood, chairman of obstetrical practices for the American College of Obstetricians and Gynecologists (ACOG).

The drug's appeal is twofold. Cytotec is much cheaper to use than other drugs: A dose costs less than 25 cents, compared with hundreds of dollars for other labor-inducing agents. It has also enabled doctors to induce more labors than ever before: Over the past decade, the induction rate has doubled -- 1 in 5 women now has her labor induced -- as doctors increasingly opt for additional medical intervention in childbirth.

Doctors often rely on Cytotec for "convenience inductions," using the drug to induce labor during office hours rather than letting nature take its course. Cytotec enables doctors to practice daylight obstetrics.

But studies highlight alarming risks associated with Cytotec. The Cochrane Collaboration, an international body of independent analysts and physicians that publishes widely respected assessments of drug efficacy, cites numerous reports of uterine rupture and fetal distress involving the drug.

Last year their report stated that "It cannot be recommended for routine use at this stage." After another study revealed a 28-fold increase in the risk of uterine rupture among women with prior cesarean sections, ACOG issued guidelines in 1999 discouraging the use of Cytotec in such cases. The organization continues to recommend Cytotec for use in routine cases, however, insisting the drug is safe at low doses.

With many doctors still regularly using Cytotec to induce labor, the toll on pregnant women and their babies is mounting. The FDA in the last three years alone, has received reports of 30 cases of uterine rupture in connection with the use of Cytotec, and 8 cases in which the fetus died in utero.

Mother Jones, January/February 2001