Cytotec (misoprostol) is a synthetic prostaglandin E1 analogue which has been used to treat gastrointestinal difficulties. According to the editorial advisors of OBGYN.net , "It's FDA (Food and Drug Administration) approved indication is for the prevention of stomach ulcers in patients taking nonsteroidal anti-inflammatory drugs." Developed by the G.D. Searle & Company in the 1970's, Cytotec has been approved and is available in approximately 70 countries with nearly 20 considering approval. In Brazil, misoprostol is for sale over the counter in pharmacies and has been for 14 years. In France, it is used in combination with RU486 (mifepristone) to increase the success of abortions up to 90%.
The FDA and Searle have partnered together to bring to both the professional and the consumer some important cautions regarding the non-approved use of Cytotec. The following are direct quotes from a letter written by Dr. Michael Cullen, the U.S. Medical Director of Searle. You may view the entire text of the Searle letter by going to the FDA web site .
"The purpose of this letter is to remind you that Cytotec administration by any route is contraindicated in women who are pregnant because it can cause abortion. Cytotec is not approved for the induction of labor or abortion."
"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, development and functional maturation of the child when Cytotec is used for induction of labor or cervical ripening has not been established."
Although approved for oral use, Cytotec has somewhat the same action on the cervix when administered vaginally as "prostin gel," "Prepidil," and "Cervidil" in that the prostaglandin action causes cervical ripening and induction of labor. The FDA has not established protocols for Cytotec usage nor has there been any controlled trial studies to provide information about the indications and contraindications surrounding use. Yet many care providers are using this gastrointestinal drug to begin inductions. Instead of printed protocols backed up by evidence from random controlled trials, protocols are shared by word of mouth and vary greatly.
Because of managed care, capitation and the closing of hospitals due to lack of financial stability, the cost of Cytotec is certainly something that needs to be addressed. At an average of 52 cents per tablet, Cytotec administration may be only ¼ to ½ tablet per person per induction. This is tragically compared to the other prostaglandin agents and Pitocin (costing hundreds of dollars) that cost more. Bucal pitocin was discontinued because of the inability to regulate contractions. Yet Cytotec is being used without known side effects such as hypertonic uterus, effects on uteri with previous scarring from cesarean sections or uterine rupture. Those that prepare Cytotec for administration in a woman's vaginal must cut the tablet with a knife into little pieces - making exact dosage and certain placement impossible. A portion of the pill can lay against the cervix or be mixed with gel and then applied. Cytotec begins and can stimulate rapid onset of contractions, opening the door for continuous electronic fetal heart monitoring because there are no established side effects on the baby. Basically, we don't know what it will do when it metabolizes through the mother's system and into the baby's system. Cytotec makes labors shorter and there is better manipulation of the time of the birth event. Better induction rates, possibly lower Cesarean sections (due to successful inductions) and less expense is the rationale for misusing this drug rather than clinically and responsibly done research.
We leave you with this thought:
Not all maternal child health professionals are comfortable with the vaginal administration of Cytotec. Marsden Wagner, MD is a neonatologist and perinatal epidemiologist. In his article Misoprostol for Labor Induction: A Cautionary Tale printed in the Spring 1999 issue of Midwifery Today, Wagner states "That the drug is not approved by the FDA for this purpose, not approved for this use by the drug manufacturer, not endorsed for this use by the American College of Obstetricians and Gynecologists or midwifery organizations and not recommended for routine use by scientists (who tell us we do not know if it is safe) has had no apparent effect on the enthusiasm with which clinicians, both doctors and midwives are starting to use it."
- Bobak, I., Jensen, M. Maternity & Gynecologic Care: The Nurse and the Family. (1989) St. Louis: Mosby Publishers.
- Nichols, F., Humenick, S. Childbirth Education: Practice, Research & Theory (2000) Saunders & Co.
- Whitely, N. A Manual of Clinical Obstetrics (1985) Philadelphia: J.B. Lippincott Company.
- Reeder, S., Martin, L., and Koniak-Griffin, D. Maternity Nursing: Family, Newborn, and Women's Health Care. (1997) Philadelphia: J.B. Lippincott Company.