Use of Cytotec (misoprostol) for Labor Induction

T he following letter concerns unapproved use of misoprostol for labor induction and is published as a follow-up to “The Nurse’s Role in Misopros- to1 Induction: A Proposal Protocol, ” by C. Wil- son, (NovemberlDecember 2000 JOGNN):

Dear Health Care Provider: The purpose of this letter is to remind you that

Cytotec administration by any route is con- traindicated in women who are pregnant because it can cause abortion. Cytotec is not approved for the induction of labor or abortion.

Cytotec is indicated for the prevention of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)-induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomi- tant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer.

The uterotonic effect of Cytotec is an inherent property of prostaglandin E,(PGE,), of which Cytotec is stable, orally active, synthetic analog. Searle has become aware of some instances where Cytotec, outside of its approved indication, was used as a cervical ripening agent prior to termina- tion of pregnancy, or for induction of labor, in spite of the specific contraindications to its use during pregnancy.

Serious adverse events reported following off- label use of Cytotec in pregnant women include maternal or fetal death; uterine hyperstimulation, rupture or perforation requiring uterine surgical repair, hysterectomy or salpingo-oophorectomy; amniotic fluid embolism; severe vaginal bleeding, retained placenta, shock, fetal bradycardia and pelvic pain.

Searle has not conducted research concerning the use of Cytotec for cervical ripening prior to termination of pregnancy or for induction of labor, nor does Searle intend to study or support these uses. Therefore, Searle is unable to provide complete risk information for Cytotec when it is

used for such purposes. In addition to the known and unknown acute risks to the mother and fetus, the effect of Cytotec on the later growth, devel- opment and functional maturation of the child when Cytotec is used for induction of labor or cervical ripening has not been established.

Searle promotes the use of Cytotec only for its approved indication. Please read the enclosed updated complete Prescribing Information for Cytotec.

Further information may be obtained by call- ing 1-800-323-4204.

Michael Cullen, M D Medical Director, U.S. Searle Skokie, IL

Celeste Phillips, The Mother of Family- Centered Maternity Care

Thanks to Celeste Phillips and all the other nurs- es who have made family-centered maternity care (FCMC) possible (“Trendsetter: Celeste Phillips, The Mother of Family-Centered Maternity Care,” JanuarylFebruary 2000 JOGNN}. As a young nurse, I have known maternity care only this way, but I have heard stories and read about the care provided to past generations. I am grateful that my experience has been much different. I have seen Phillips’s principles applied to maternity care in both my professional and personal life. As the mother of a 19-month-old, I remember the sup- port of my family and friends during the time of her birth. This would not have been possible without FCMC. Fathers can now be involved in the birth of their children, an important experi- ence for both parents, thanks to FCMC.

The principle of FCMC has affected the med- ical industry more than any other philosophy. It has transformed the way that nurses deliver health care to the childbearing family and changed the safety and quality of care given to the mother and newborn. Most important, it has pro- moted family unity (Sherwen, Scoloveno, & Weingarten, 1995).

January I February 2001 JOGNN 11

I agree with Phillips’s 10 principles, which I experi- enced with the care of my daughter. She was born pre- maturely and air-transported to a neonatal intensive-

Michelle Ham, RN, BSN The University of Texas Southwestern Medical School

care unit (NICU) ou tb f town. I saw firsthand these principles applied to the initial care, helicopter transport, and the subsequent care in the NICU. The fact that I

birth has been maintained. Therefore, with this foun- dation we should be able to meet the challenges that technology will bring in this century.

was able to be closely involved and had access to her at all times made this stressful situation easier to endure. 1 REFERENCE

I further agree with Phillips’s beliefs regarding criti- cal challenges to maternity and newborn care brought about by the growing technology of the 21st century. Through the use of FCMC, the human element of child-

Sherwen, L. N., Scoloveno, M. A., & Weingarten, c. T. (199.5). Nursing care of the childbearing family. (3rd ed.). East Norwalk, CT: Appleton & Lange.

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