Is There a Risk to Women with No Previous Uterine Surgery?
The medical literature, as well as an online obstetrician discussion group, contains case reports of uterine rupture in women with no prior uterine surgery (2, 3, 6, 11). Some of these have resulted in hysterectomies. However, because these are single, unusual incidents, it is difficult to judge the degree of risk compared with other labor induction agents, which themselves are not risk free.
ICAN Calls for Ban On Labor Induction Drug Due to Safety Concerns
The International Cesarean Awareness Network (ICAN) is calling for an immediate ban on the obstetrical use of the drug misopristol (Cytotec) as a labor induction method that doctors say is safe. ICAN contends that doctors are putting women at risk by ignoring warnings from the manufacturer, the G.D.Searle Corporation, as well as numerous studies which show that the risks of the drug are quite significant.
Cytotec has not been approved by the FDA for obstetrical use.
Recently, an Oakland, California woman died after the drug's use in her labor. According to an article in the Oakland Urbanview, the woman's husband stated that neither he nor his wife were fully informed of the drug's risks. The warning on the manufacturer's package insert explicitly states that "Cytotec may cause the uterus to rupture in pregnant women if it is used to induce labor." "Uterine rupture," it continues, "may result in severe bleeding, hospitalization, surgery, infertility, or death." Cytotec causes hyperstimulation of the uterus, a dangerous complication which may also result in fetal injury and death.
According to the American College of Obstetricians and Gynecologists, (ACOG) an estimated one in five labors are now induced, and Cytotec is the agent of choice. A May 1998 study in ACOG's own journal reported that clinical trials on the drug had to be stopped because of safety concerns and that Cytotec should not be used on women with a prior uterine incision. The recommendations came after several studies showed that these women were at a much higher risk of uterine rupture when induced with Cytotec.
In addition, the Cochrane Collaboration, an international and independent group of physicians and researchers which analyzes the effectiveness of various drug treatments, issued this statement after its most recent 2002 review on the obstetrical use of Cytotec: " It cannot be recommended for routine use at this stage." It also adds, "Further research is needed to establish safety. Information on women's views is conspicuously lacking."
A Virginia consumer group called Virginia Birthing Freedom has initiated legislation which requires health care providers and pharmacists who prescribe or dispense misopristol to give informed consent to women receiving the drug, including risks and possible adverse effects. ICAN endorses the legislation.