NurseWeek

Searle warns against ulcer drug's use for abortion

By Noel Holton
August 29, 2000
Health24News


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Washington (H24N). The fact that Cytotec, a drug manufactured by Searle to treat ulcers, has been used by some women to induce labor or to abort their pregnancies prompted the company to send health care providers a letter warning them about the risks of the off-label use of the drug.

In a letter dated Aug. 23, Searle, based in Skokie, Ill., reminds providers that Cytotec is contraindicated in pregnant women because of its potential to induce labor and cause abortion with fatal consequences for both the fetus and the mother.

The drug has approval from the Food and Drug Administration (FDA) for the prevention of ulcers in patients taking nonsteroidal anti-inflammatory drugs, including aspirin. These drugs can cause gastric ulcers in vulnerable patients, such as those with a history of ulcers and the elderly.

"Searle has become aware of some instances where Cytotec, outside of its approved indication, was used as a cervical ripening agent prior to termination of pregnancy, or for induction of labor, in spite of the specific contraindications to its use during pregnancy," wrote Seale in its letter to health care providers.

Although Searle has not studied the use of Cytotec for the induction of labor or the termination of pregnancy and has no plans to, reports of adverse reactions related to off-label use of the drug by pregnant women have been disturbing. They include maternal or fetal death, uterine hyperstimulation, rupture or perforation requiring uterine surgical repair or hysterectomy, amniotic fluid embolism, severe vaginal bleeding, retained placenta, shock, fetal bradycardia (slowed heart beat) and pelvic pain.

In its letter to health care providers, Searle also cautions doctors about the lack of information available about Cytotec's effect on children delivered by mothers who have taken the drug to bring on labor. "The effect of Cytotec on the later growth, development and functional maturation of the child when Cytotec is used for induction of labor or cervical ripening has not been established," wrote Searle. For more information, visit the FDA Web site.