Uterine Ruptures Associated with Prostaglandin Used with RU486.(Cytotec)

When the manufacturer of the anti-ulcer drug Cytotec released a letter August 23, 2000, to warn doctors of injuries associated with unsanctioned ["off-label"] obstetrical uses of the drug, the pro-abortion American College of Obstetricians and Gynecologists (ACOG) publicly questioned the "content, timing, and tone" of G.D. Searle's letter.

What upset ACOG was its fear that Searle's letter could "limit the use of this new option for reproductive choice" (ACOG Letter, 10/26/00). ACOG was concerned that Searle's letter might have an impact on doctors or hospitals considering the use of Cytotec in conjunction with the abortion pill RU486, which received marketing approval from the Food and Drug Administration (FDA) last September.

Contrary to the implications of ACOG's letter, however, Searle's letter was prompted by reports of uterine ruptures that the company had received associated with some off-label uses of its drug. Searle specifically addressed Cytotec's off-label use as a cervical ripener, labor inducer, or a stand-alone abortifacient. Now, independent evidence has surfaced that Searle's concerns about Cytotec's use as a labor inducer were amply justified.

In its January/February issue, Mother Jones magazine reports that a Freedom of Information Act request made to the FDA has uncovered 30 cases of uterine ruptures reported to the FDA involving Cytotec in just the past three years and eight cases involved the death of a child in utero.

To illustrate, Mother Jones relates the case of 34-year-old expectant mother Suzanne Altomare. Eight days past her due date in November 1995, Altomare's doctor, Thomas Kahan, decided to administer two doses of Cytotec to induce labor.

The article then relates what transpired over the next few hours:

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 to 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 caesarean 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.