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Sunday, Nov 8, 2009
A few years passed before the first published reports appeared detailing Cytotec's adverse effects on labor induction. By then, word of mouth in medical circles had made Cytotec the new darling of American obstetrics. Cost-effective, quick and easy to administer, Cytotec was fast becoming a popular alternative to Pitocin, which requires a full high-tech approach, including I.V., continual fetal monitoring and often (because of its reputation for triggering especially painful contractions) an epidural. Cytotec, in contrast, can be administered (though it shouldn't be) in virtually any setting.
Just how many women have been hurt by Cytotec? The question is nearly impossible to answer. No one has done large-scale studies of the drug, and the doctors and midwives who administer it do so with such vastly different protocols that mixing and matching results from various studies would not render reliable data. The most rigorous scientific authority in English on the effects of healthcare, the Cochrane Library, cautions that too few well-designed studies have been carried out to assess the risk factors associated with using Cytotec for labor induction. While conceding that Cytotec is more effective than conventional methods of cervical ripening and labor induction, it cautions that "the apparent increase in uterine hyperstimulation is of concern."
Unable to find large-scale, comprehensive reporting on obstetric use of the drug, I decided to do a little statistical sleuthing (however unscientific) on my own. My research, and my gut sense, based on years of experience as a midwife, indicate that there are significant risks associated with Cytotec, certainly higher risks than those associated with other forms of induction like Pitocin. Combining the results in 20 studies of Cytotec-induced labors published in peer-reviewed journals and papers presented at professional meetings -- a total of 1,958 births -- I discovered a total of two maternal deaths, 16 baby deaths, 19 uterine ruptures and two life-threatening hysterectomies.
To make sense of these figures, consider the normal incidence of uterine rupture, the most common serious side effect of Cytotec. Uterine rupture virtually never occurs in spontaneous (unaugmented) labor in women who've had no previous uterine surgery. Probably because of differing practices surrounding labor induction and augmentation, the rate of uterine rupture varies widely from hospital to hospital. Uterine rupture is less likely to happen in an out-of-hospital birth. Most midwives providing these services do not use drugs to augment labor. The complication has been reported as frequently as one in every 100 births and as rarely as one in every 11,000 births. In my own group practice at the Farm Midwifery Center in Summertown, Tenn., in approximately 2,100 births we have had no uterine ruptures.
By contrast, approximately one in 100 Cytotec-induced births in the 20 studies I looked at resulted in uterine rupture. About half occurred in women having vaginal birth after Caesarean, the others among women who had had no previous uterine surgery.
In fact, it is women who have had Caesareans who are at greatest risk from Cytotec. An article published in 1999 in the American Journal of Obstetrics and Gynecology reported that uterine rupture occurred in five of 89 women with previous Caesarean delivery whose labors were induced with Cytotec -- about one out of 16, a shockingly high figure, representing a more than 28-fold increase over those who did not have Cytotec induction for VBAC (vaginal birth after Caesarean). One of the five ruptures also caused a baby to die.
According to epidemiologist Wagner, "It can be reliably estimated that between 1990 and 1999, as a result of the widespread off-label use of Cytotec for vaginal birth after Caesarean section, well over 3,000 women in the United States suffered a ruptured uterus, resulting in at least 100 dead newborn babies."
Amniotic fluid embolism, or AFE, is perhaps the most frightening complication associated with powerful labor-inducing drugs like Cytotec and Pitocin. AFE, which occurs when the amniotic fluid enters the mother's bloodstream, is one of the most dangerous complications that can happen in birth. More than 60 percent of women and their babies die when it occurs, with survivors usually suffering neurological impairment.
The rate of occurrence of AFE, once thought to occur only once in 80,000 births, seems to be rising in the United States. Chicago writer Deanna Isaacs, whose daughter died from AFE in 1994, found that the incidence of AFE at the Phoenix, Ariz., hospital where her daughter died in labor was 1 in only 6,500 births. AFE is now one of the leading causes of maternal death in the United States. Two cases of fatal AFE are associated in the medical literature with the use of Cytotec; a midwife told me about a third.
Alarmingly high as these figures are, they almost certainly don't reflect all of the adverse outcomes associated with Cytotec. I also gathered information -- much of it hair-raising -- from Internet chat-room discussions involving physicians who signed their names to their comments, as well as from obstetricians and midwives. This is anecdotal evidence, yes. But we can't afford to ignore anecdotes because current medical studies are inadequate, the drug has not been subject to FDA approval and mothers' and infants' lives are at stake.
