Henci Goer’s Cytotec Article

Cytotec: Safe for Inducing Labor?

by Henci Goer

It is becoming more common for hospitals to use Cytotec (misoprostol or prostaglandin E1) to ripen a woman’s cervix and induce labor. Cytotec is a small pill that can be taken orally or broken in pieces and inserted vaginally.

There are growing concerns about the safety of this drug when used for labor induction. A November 1999 Committee Opinion of the American College of Obstetricians and Gynecologists (ACOG) warns: “There have been reports of uterine rupture following misoprostol use for cervical ripening in patients with prior uterine surgery. Thus, until reassuring studies are available, misoprostol is not recommended for cervical ripening in patients who have had prior cesarean delivery or major uterine surgery” (1).

Cytotec’s only FDA-approved use is treating ulcers. In August 2000, Searle, Cytotec’s manufacturer, sent physicians a letter reminding them that Cytotec was not approved for use as a cervical ripening agent and that it was contraindicated for use in pregnancy (14). The letter listed serious adverse effects associated with using Cytotec, including maternal or fetal death, uterine rupture, and severe vaginal bleeding and shock.

Why is Cytotec Being Used?
Cytotec is no more effective, and much less safe than Prepidil or Cervidil ( prostaglandin E2), another agent used in the hope of reducing the cesarean rate in labors induced with an unripe cervix. An analysis of 16 trials, in which women were randomly assigned to receive either Cytotec or Prepidil/Cervidil, showed similar cesarean rates (8). Two additional randomized controlled trials comparing the two, and published after the analysis, also found similar cesarean rates (10, 12). Among all 18 trials, totaling 2,550 women who received one labor induction drug or another, cesarean rates were 19 percent with Cytotec and 20 percent with Prepidil/Cervidil. As for safety, a review of 10 studies, totaling 832 VBAC women given Prepidil, reported no uterine ruptures. (4)

Cytotec’s sole appeal is price. Cytotec costs pennies per induction, whereas Prepidil and Cervidil cost close to $100 per dose, and more than one dose may be needed (3). Cytotec also reduces the need for intravenous oxytocin (Pitocin), the hormone that stimulates contractions, another savings.

Cytotec for VBACs?

A search of the medical journals produced four reports describing 13 uterine ruptures following the use of Cytotec in women having induced labors after prior cesareans (3, 13, 15-16). These resulted in two hysterectomies and two deaths of babies.

In one study, eight percent of VBAC women experienced a uterine rupture, compared with 0.2 percent of VBAC women beginning labor on their own (13). These authors also searched the medical journals for other studies of Cytotec use in VBAC inductions

and collected eight studies, comprising 122 VBAC women, of whom six (five percent) experienced uterine ruptures. A study published after this one added another 131 VBAC inductions with Cytotec. It reported no uterine ruptures, although its authors did found that Cytotec substantially increased the risk of placental abruption in VBAC women, compared with women with no scar. (9). Looking at these statistics, it is estimated that uterine rupture occurs in four percent of VBAC women given Cytotec. This compares with a 5 per 1000 (0.5 percent) overall rate of uterine rupture in VBAC labors (5, 7). This means that using Cytotec increases the risk of uterine rupture in women with a scarred uterus eight-fold.

It isn’t clear why Cytotec appears to pose a special risk to women with uterine scars. One study’s authors speculated that Cytotec may soften the connective tissue of the scar in addition to softening the connective tissue in the cervix .

Is There a Risk to Women with No Previous Uterine Surgery?

The medical literature, as well as an online obstetrician discussion group, contains case reports of uterine rupture in women with no prior uterine surgery (2, 3, 6, 11). Some of these have resulted in hysterectomies. However, because these are single, unusual incidents, it is difficult to judge the degree of risk compared with other labor induction agents, which themselves are not risk free.

ICAN Calls for Ban On Labor Induction Drug Due to Safety Concerns
The International Cesarean Awareness Network (ICAN) is calling for an immediate ban on the obstetrical use of the drug misopristol (Cytotec) as a labor induction method that doctors say is safe. ICAN contends that doctors are putting women at risk by ignoring warnings from the manufacturer, the G.D.Searle Corporation, as well as numerous studies which show that the risks of the drug are quite significant.

Cytotec has not been approved by the FDA for obstetrical use.
Recently, an Oakland, California woman died after the drug’s use in her labor. According to an article in the Oakland Urbanview, the woman’s husband stated that neither he nor his wife were fully informed of the drug’s risks. The warning on the manufacturer’s package insert explicitly states that “Cytotec may cause the uterus to rupture in pregnant women if it is used to induce labor.” “Uterine rupture,” it continues, “may result in severe bleeding, hospitalization, surgery, infertility, or death.” Cytotec causes hyperstimulation of the uterus, a dangerous complication which may also result in fetal injury and death.

According to the American College of Obstetricians and Gynecologists, (ACOG) an estimated one in five labors are now induced, and Cytotec is the agent of choice. A May 1998 study in ACOG’s own journal reported that clinical trials on the drug had to be stopped because of safety concerns and that Cytotec should not be used on women with a prior uterine incision. The recommendations came after several studies showed that these women were at a much higher risk of uterine rupture when induced with Cytotec.

In addition, the Cochrane Collaboration, an international and independent group of physicians and researchers which analyzes the effectiveness of various drug treatments, issued this statement after its most recent 2002 review on the obstetrical use of Cytotec: ” It cannot be recommended for routine use at this stage.” It also adds, “Further research is needed to establish safety. Information on women’s views is conspicuously lacking.”

A Virginia consumer group called Virginia Birthing Freedom has initiated legislation which requires health care providers and pharmacists who prescribe or dispense misopristol to give informed consent to women receiving the drug, including risks and possible adverse effects. ICAN endorses the legislation.

Source: International Cesarean Awareness Network Press Release, April 2002
REFERENCES

1. ACOG. Induction of labor with misoprostol. Committee Opinion #128, Nov 1999.
2. Bennett BB. Uterine rupture during induction of labor at term with intravaginal misoprostol. Obstet Gynecol 1997;89(5 Part 2):832-3.
3. Blanchette HA, Nayak S, and Erasmus S. Comparison of the safety and efficacy of intravaginal misoprostol (prostaglandin E1) with those of dinoprostone (prostaglandin E2) for cervical ripening and induction of labor in a community hospital. Am J Obstet Gynecol 1999;180:1551-9.
4. Chez RA. Cervical ripening and labor induction after previous cesarean delivery. Clin Obstet Gynecol 1995;38(2):287-92.
5. Flamm BL. Vaginal birth after cesarean section. In Cesarean Section: Guidelines for Appropriate Utilization. Flamm BL and Quilligan EJ, eds. New York: Springer-Verlag, 1995.
6. Gaskin IM. Two sides to the Cytotec debate. Birth Gazette 2000;16(2):7, 48-49.
7. Goer H. The Thinking Woman’s Guide to a Better Birth. New York: Perigee Books, 1999.
8. Hofmeyr GJ, Gulmezoglu AM, and Alfirevic Z. Misoprostol for induction of labour: a systematic review. Br J Obstet Gynaecol 1999;106:798-803.
9. Humphrey RG, Carlan SJ, and O’Leary TD. Misoprostol for cervical ripening in patients with previous cesarean delivery. Obstet Gynecol 2000;95(4 Suppl 1):S70.
10. Kolderup L et al. Misoprostol is more efficacious for labor induction than prostaglandin E2, but is it associated with more risk? Am J Obstet Gynecol 1999;180(6 Pt 1):1543-50.
11. Mathews JE, Mathai M, and George A. Uterine rupture in a multiparous woman during labor induction with oral misoprostol. Int J Gynaecol Obstet 2000;68(1):43-4. Am J Obstet Gynecol 1999;181(3):626-9.
12. Nunes F, Rodrigues R, Meirinho M. Randomized comparison between intravaginal misoprostol and dinoprostone for cervical ripening and induction of labor. Am J Obstet Gynecol 1999;181(3):626-9.
13. Plaut MM, Schwartz ML, and Lubarsky SL. Uterine rupture associated with the use of misoprostol in the gravid patient with a previous cesarean section. Am J Obstet Gynecol 1999;180:1535-42.
14. Reuters Health. Off-label Cytotec use for labor, abortion prompts Searle letter to physicians. Aug 29, 2000.
15. Sciscione AC et al. Uterine rupture during preinduction cervical ripening with misoprostol in a patient with a previous cesarean delivery. Aust NZ J Obstet Gynaecol 1998;38(1):96-97.
16. Wing DA, Lovett K, and Paul RH. Disruption of prior uterine incision following misoprostol for labor induction in women with previous cesarean delivery. Obstet Gynecol 1998;91(5 Part 2):828-30.

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