Inducing Labor with Cytotec: A Questionable Practice

For one reason or another, induction of labor is becoming a more common practice in the United States. In addition to natural methods used uncommonly, there are several options that hospitals have to jump start or pick up a slow-to-start labor. One of these options is a drug called Cytotec, known by its generic name, Misoprostol.

Cytotec is a small pill produced by G.D. Searle & Co. to reduce stomach ulcers. Directly on its label, Searle warns against the use of Cytotec on pregnant women, but somehow doctors figured out that it was a cheap and effective way to induce labor. So Cytotec became an "on-label contraindicated" method of induction.

What were the reasons that G.D. Searle gave the American College of Obstetricians and Gynecologists for warning against induction by Cytotec? Hyperstimulation of the uterus causing uterine rupture, severe fetal distress, amniotic fluid embolism, pelvic pain, retained placenta, severe genital bleeding, fetal bradycardia, cesarean delivery, and fetal and maternal death, all of which have been recorded as actual results of the use of Cytotec for the purpose of inducing labor¹. Shock, fetal brain damage, and newborn pneumonia have also been recorded as side effects of Cytotec^2,3.

Despite the fact that both the manufacturer of Cytotec and the FDA strongly advised against its use, ACOG issued a committee opinion in 2000 stating that if it is used appropriately, Cytotec is a safe and effective agent⁴. By appropriately, they meant not using it for VBAC labors, women with previous uterine surgery, or in labors that are progressing abnormally or with fetal distress. However, it has long been known that the side effects of Cytotec (such as uterine rupture) can occur in both low and high risk categories, regardless of dosage, which explains why so many organizations are still taking a stand against its use.

The only organization recommending Cytotec for use in labor is ACOG. Here are the organizations which advise against it: the US FDA, Best Scientific Opinion - Cochrane Database, G.D. Searle & Co., Society of Obstetricians and Gynecologists of Canada, British Royal College of Obstetricians and Gynecologists, all obstetric organizations in Scandinavia, International Federation of Obstetricians and Gynecologists, World Health Organization, as well as obstetric organizations and drug regulatory agencies in many other countries⁵.

In 2005, the FDA again released a warning to physicians, not to use Cytotec as an induction agent, saying that not enough scientific proof had been found to say that the drug was safe and effective for these uses. They also said that if physicians do use it, they must warn their patients of all known side-effects, or they may be in serious legal danger, not to mention putting mother and baby at needless risk⁶. Early in 2006, Pfizer, the current producer of Cytotec, also advised against pregnant women using the drug⁷.

According to MotherFriendly.org, the only benefits of Cytotec over Prostoglandin E2 (a similarly used induction agent) are a much reduced cost and faster labors. Both of these only benefit hospitals and doctors as shorter labors are usually more "intense, tumultuous, and difficult"⁸.

As a result of these findings, it would be appropriate for women facing induction to first consider the necessity of induction in their particular case, and second, an alternative to Cytotec, also known as Misoprostol.

Resources:
1 - www.pfizer.com/files/products/uspi_cytotec.pdf
2 - www.wikipedia.org
3,8 - www.motherfriendly.org
4,7 - www.medicalnewstoday.com/medicalnews.php?newsid=43186
5 - "Cytotec Induction and Off-Label Use" by Marsden Wagner, MD, MS. Midwifery Today Issue 67 Fall 2003
6 - www.fda.gov/cder/drug/infopage/misoprostol/default.htm