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To jump-start her labor, Altomare was given two doses of Cytotec, a drug known to soften the cervix and cause uterine contractions that are more frequent and powerful than normal labor. What Altomare did not know was that Cytotec has not been approved by the Food and Drug Administration (FDA) for use in pregnant women. 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." According to court records and sources familiar with the case, Altomare soon went into very active labor. But several hours later, a delivery nurse at the hospital in Salem, Oregon, was no longer able to detect a fetal heart tone or find the baby's head on a vaginal exam. Altomare's uterus had ruptured, causing internal bleeding in the mother and leaving the baby without oxygen. The nurses called Dr. Kahan, who was at home. By the time he arrived and mobilized an emergency cesarean section, the infant was brain-dead. Kahan then performed an emergency hysterectomy. When Altomare awoke, she learned that she would never again be able to bear a child. Her newborn daughter died three days later. 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. This "off-label" use is legal, thanks to an FDA loophole: Once a drug is approved for one purpose, it can be used by physicians to treat anything. Note: Misoprostol, the generic name for Cytotec, is also used in combination with RU-486: The abortion drug ends the pregnancy; misoprostol causes the uterus to expel its contents. Source: Pro-Life E-News (enews@interlife.org)
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