Cyotec: Concerns and Controversies
by Jeanne Ohm, DC
The drug cyotec (misoprostol) is gaining much attention in the birthing community. Originally approved by the FDA for the treatment of ulcers, cyotec is being used "off label" as a quick, inexpensive way to induce labor. Although there is great zeal for it ability to soften a woman's cervix and speed up the delivery process, there is growing concern about its life-threatening side effects.
Searle, the manufacturers of this drug have specific warnings in their package inserts. "Uterine rupture has been reported when cyotec was administered intravaginally in pregnant women to induce labor…"1 One national magazine did an article on the use of cyotec citing cases of uterine hemorrhage leading to hysterectomy, maternal death and even fetal death.2
Marsden Wagner, MD, a neonatologist and perinatal epidemiologist. wrote an outstanding article on the misuse of cyotec in Midwifery Today, Issue 49, 1999.3 Although he includes "testimonials" from cyotec advocates in the birthing community, Dr. Wagner strongly cautions about the potential dangers of its unintended use for induction. His article offers critical review of the published studies on the use of cyotec and cites significant weaknesses in their approaches and findings.
The following excerpt was published in Midwifery Today's E-Newsletter, Vol 3. Issue 49:
Induction with Cytotec should never be attempted anywhere, most especially in out-of-hospital settings. Incredibly, the American College of Obstetricians and Gynecologists (ACOG) recently approved Cytotec induction in spite of lack of FDA approval; in spite of a letter to doctors from Searle, the manufacturer of Cytotec, imploring doctors not to use it for induction; in spite of lack of approval from the Cochrane Library (the best scientific opinion); and in spite of the fact that it is not approved or used for induction in any country in Western Europe.
ACOG quotes studies of Cytotec induction, none of which have a sufficient number of research subjects, and consequently none of the studies quoted have sufficient statistical power to detect small but potentially important risks such as uterine hyperstimulation and uterine rupture. Furthermore, because published studies of Cytotec induction have such wide methodological variability, meta-analysis is impossible and the published attempts at such meta-analysis are seriously flawed.... Midwives should stay as far away as possible from such vigilante obstetrics--obstetricians taking matters into their own hands while ignoring the recommendations of the real judges.- excerpted from "Midwives and Cytotec: A True Story, by Marsden Wagner, MD, Midwifery Today Issue 57.4,5
Searle, the makers of cyotec have strongly warned ob/gyns about the use of cyotec for induction. They put out a letter to birth providers stating the gruesome side-effects cyotec may have on both the mother and baby.6 It has been shown to be particularly harmful causing hemorrhage when used in a vaginal birth after cesarean.7 In spite of the above referenced warnings, its use continues to rise. Because of the published protocols in ob/gyn journals for the use of cyotec in induction and the popularity this drug is gaining in the ob/gyn circles, we can expect an increase in its use.8.9
When it comes to our own health and well-being and the safety of our children, making informed decisions is the key. It is my suggestion that you visit the web addresses below and print out copies of this information for your personal resource.
References:
1) http://www.motherjones.com/mother_jones/JF01/cytotec_label.pdf
2) http://www.motherjones.com/mother_jones/JF01/labor.html
3) http://www.midwiferytoday.com/articles/default.asp?t=cytotecwagner
4) http://www.midwiferytoday.com/articles/default.asp?t=misoprostol
5) http://www.midwiferytoday.com/articles/default.asp?t=midwivescytotec
6) http://www.birthlove.com/pages/devil_cytotec.html#info
7) http://www.mothering.com/11-0-0/html/11-2-0/11-2-cytotec107.shtml
8) http://www.mercola.com/2001/feb/4/cytotec_pregnancy.htm
9) http://www.acog.org/from_home/publications/press_releases/nr11-30-00-3.htm