FDA Alert on Cytotec

On May 16, 2005, the FDA issued an FDA Alert on the risk of Cytotec (Misoprostol) when used in labor and delivery, which states:

"This Patient Information Sheet is for pregnant women who may receive Misoprostol to soften their cervix or induce contractions to begin labor. Misoprostol is sometimes used to decrease blood loss after delivery of a baby. The FDA does not approve these uses. No company has sent the FDA scientific proof that Misoprostol is safe and effective for these uses.

"There can be rare but serious side effects, including a torn uterus (womb), when Misoprostol is used for labor and delivery. A torn uterus may result in severe bleeding, having the uterus removed (hysterectomy), and death of the mother or baby. These side effects are more likely in women who have had previous uterine surgery, a previous Cesarean delivery (C-section), or several previous births."

The FDA Alert makes it clear that 1) Cytotec should not be used for labor induction 2) BUT that, if it is to be used against this FDA recommendation every woman receiving Cytotec for induction has the right to fully informed consent which must include the risks listed in this FDA release. Failure to provide a woman with ALL the information regarding the side effects of Cytotec (Misoprostol) when used for the induction of labor denies the patient the right to give her fully informed consent and may result in serious legal exposure to those health care providers as well as needlessly jeopardizing the health of the mother and her child.

The TOFM Foundation petitioned the FDA in November 2004 to issue a more comprehensive advisory regarding the dangers of Cytotec (Misoprostol). The TOFM Foundation applauds the action of the FDA, yet there is more that must be done to alert physicians, nurses, hospitals, pharmacists and patients related to potential catastrophic outcomes that can occur when Cytotec (Misoprostol) is used for inducing labor and/or ripening the cervix.

The FDA Alert on Cytotec can be found at:

Inductions Lead to Repeat C-Sections

The frequency of elective inductions have risen dramatically. They are primarily for scheduling convenience. Either the planned date works out better for the doctor, or the parents are given an option "when to deliver" for their personal convenience.
Although inductions have their potential hazards in any birth, July OB/Gyn 2001 reports that inducing a woman for a birth after a previous c-section increases the possibility of uterine rupture.

These findings contrast sharply with the risk of uterine rupture in a natural Vaginal Birth After Cesarean. Women should continue to opt for VBACs and insist on their right for natural childbirth. It appears, even when there are limitations of matter( previous uterine scar tissue), letting nature take its course (natural childbirth) is still the way to go!

Drug-Free Childbirth Prevents Repeat C-Section

While inducing labor with medication poses dangers for all deliveries, it's especially hazardous for women who have had previous Caesarean sections, researchers report. The study enrolled 179 women with a history of C-section. Of the 57 who had their labor induced, 57.9% had successful vaginal deliveries, compared with 77.1% of those who did not use labor-inducing drugs. Among women who went into labor spontaneously, those who used oxytocin had a 64.5% chance of avoiding C-section, compared with 87.5% of mothers who did not use oxytocin. For mothers who delivered via C-section in the past, inducing labor not only ups the risk of repeat C-section but also multiplies the odds of uterine rupture.

Sims EJ, Newman RB, Hulsey TC Vaginal birth after cesarean: to induce or not to induce. Am J Obstet Gynecol. 2001; 184(6):1122-4.


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.

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. It is my suggestion that you visit the web addresses below and print out copies of this information for your patients' education. Once again, if we don't tell them, who will?


  1. The Cyotec label (In Adobe Acrobat Format)
  2. Forced Labor: Why are obstetricians speeding deliveries with an ulcer drug that endangers mothers and their babies?
  3. Misoprostol (Cytotec) for Labor Induction: A Cautionary Tale


    Are there problems associated with the use of Pitocin? Yes!

    Oxytocin, your body's natural hormone, is secreted in bursts. However, when you are given pitocin you are placed on a regulated intravenous pump, to regulate the amount of pitocin to a steady flow. Therefore, pitocin induced contractions are entirely different from your body's natural contractions, in both strength and effect.

    With pitocin, the induced force of the contraction may decrease uterine blood flow (This is also done during a natural contraction, but not for as long of a period and not as close together.). Therefore, reducing the oxygen to the baby. You will also receive continuous electronic fetal monitoring with pitocin . This is because fetal distress is more common with pitocin use and needs to be detected if it occurs.

    We have also witnessed that pitocin can be the first domino in the domino effect. The IV, the infusion pump, and the continuous monitoring will confine most mothers to bed, decreasing her ability to deal with the contractions naturally. With the more painful contractions a mother is more likely to need pain medication, such as an epidural

    Pitocin can present other hazards. For the mother these include: turbulent labor and tetanic contractions, which may cause early separation of the placenta (placenta previa), rupture of the uterus, laceration of the cervix or post birth hemorrhage. Fetal hazards include: fetal asphyxia and neonatal hypoxia from too frequent and prolonged uterine contractions, physical injury and prematurely if the due date is not accurate.

    Read more about the effects of drugs in labor:

    Pitocin: IS THE PIT BULL?
    Search Midwifery Today Archives : Pitocin