Cytotec Off-Label Use to Induce Labor Raises Concern
Ever since peptic ulcer drug Cytotec was approved in 1988, a "growing number" of obstetricians have "embraced it as a 'miracle' drug" for inducing labor, despite data raising "serious" safety concerns, Mother Jones reports. The G.D. Searle Corp.-manufactured drug -- known generically as misoprostol, which is also used with the recently-approved drug mifepristone to induce abortions -- softens the cervix and causes uterine contractions "more frequent and powerful than normal labor." Women who receive Cytotec are more likely to have a vaginal delivery within 24 hours and no more likely to have a cesearean section delivery than women who receive no labor-inducing drug. According to Dr. Charles Lockwood, obstetrical practices chair for the American College of Obstetricians and Gynecologists, Cytotec now is the "predominant agent of choice" to induce labor. However, the FDA has not approved the drug for use in pregnant women, and Searle includes a warning on the drug's package, stating that Cytotec might "cause the uterus to rupture (tear) during pregnancy if it is used to bring on (induce) labor."
Cytotec's use to induce labor is legal, however, due to an FDA loophole that allows approved drugs to be used by physicians to "treat anything." Doctors use the drug because at 25 cents per dose, it is "much cheaper" than other labor-inducing agents that cost "hundreds of dollars." Doctors also can induce more labors "than ever before," as evidenced by the doubled induction rate over the last 10 years. Neonatologist Dr. Marsden Wagner said, "Cytotec enables doctors to practice daylight obstetrics. It means that as a doctors, I can come in at 9 a.m., give you the pill, and by 6 p.m. I've delivered a baby and am home having dinner."
However, several studies have warned of "alarming risks" associated with Cytotec. According to the Cochrane Collaboration, an international organization of independent analysts and physicians, there have been "numerous" reports of uterine rupture and fetal distress related to the drug's use. During the last three years, the FDA has received reports of 30 cases of uterine rupture and eight cases of fetal death in connection with Cytotec. Furthermore, in 1999, ACOG issued guidelines discouraging Cytotec's use in women with prior cesearean sections. However, the organization does recommend the drug's use at low doses in "routine" cases. Cytotec also has "become the subject of lawsuits," with two women winning large settlements after their newborns died in conjunction with the drug's use. Michael Koskoff, an attorney who is representing a man whose wife died after being given Cytotec, said, "For the drug company, the off-label use allows for potentially massive sales of the drug without making any warranties for its efficacy or safety.
It is equally advantageous for medical professionals, since it allows them to use the drug in essentially an unregulated manner." Despite the safety concerns, some doctors have "reacted angrily" to the warnings. Last August, Searle sent 200,000 care providers a letter warning that "Cytotec administration by any route is contraindicated in women who are pregnant because it can cause abortion." At least one-third of the nation's hospitals have restricted Cytotec use in response to the letter, according to Mother Jones. But Dr. Steven Clark, professor of obstetrics and gynecology at the University of Utah School of Medicine, said, "I think [the warning] is a great setback to women's health" (Goodman, Mother Jones, January/February 2001 issue).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.