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Cytotec, also known by its generic name misoprostol, is a drug approved by the Food & Drug Administration (“FDA”) for the purpose of preventing stomach ulcers. Despite this fact, many obstetricians prescribe Cytotec to induce labor in pregnant women, an unapproved, or “off label” use. The drugs manufacturer, Searle, has never performed clinical trials to determine Cytotec’s safety when given to pregnant women as an inducement agent. Furthermore, Searle has never promoted or marketed the drug for any purpose other than as an anti-ulcer medication.
Because clinical trials were never conducted regarding the use of cytotec as an induction agent, over the last decade doctors who prescribed the drug for such purpose were experimenting on their patients to learn the appropriate dosage level to prompt labor. As a result, many women suffered severe and life threatening adverse reactions to cytotec including ruptures of the uterus, birth injuries to their children and death of the mother and/or child. This proved especially true in those instances where a mother had previously undergone a cesarean section.
As most profoundly stated by Ina May Gaskin, one of the founders of the natural childbirth movement, in her article, Cytotec: Dangerous Experiment or Panacea?:
“Over the past three years I have watched in increasing dismay as this once little-known ulcer medication has become a popular obstetric drug — one with potentially horrifying side effects and a frightening lack of safety protocols. Buried in study after study, reports show that the drug has been connected to numerous cases of ruptured uteri and even a few maternal deaths, stillbirths and newborn deaths…
In fact, the widespread use of Cytotec essentially amounts to a massive medical experiment carried out on thousands of unsuspecting women — a situation, sadly, that is all too common in the world of modern obstetrics…
Unlike a Pitocin drip, which has a half-life in the body of about 10 minutes and can easily be turned off if the woman responds to it violently, once Cytotec is administered, you can’t get it out and nobody knows its half-life. This gives Cytotec an unpredictable, stealthy element. Sometimes even when it is doing serious damage to the uterus, the woman has no awareness that something’s wrong; other times it creates immediate violent contractions. Moreover, the ruptures can occur many hours after a single dose in which the drug seemed to have caused no adverse effects. No one understands how this works, but it has been the subject of discussion both in the medical literature and in physician chat rooms…
Finally, in an era of managed-care obstetrics in which doctors are seeing patients in their offices at the same time that they monitor other women’s labors across town in the hospital by telephone, Cytotec’s great claim to fame — prompt, timely labors — is a phenomenal boon. In most cases an obstetrician must be present at the time the baby is born to be paid in full for a birth. So financial factors may influence some doctors to induce labor at a convenient time. Moreover, most cases of malpractice litigation involve situations in which doctors were not present and an adverse outcome occurred. Hence doctors have ulterior motives for using drugs like Cytotec, which help speed labor and thereby ensure that they won’t miss the big event.
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.
How was it that Cytotec came to be used as an obstetric drug in the first place? Misoprostol was originally developed by G.D. Searle & Co. of Chicago to prevent gastric ulcers in people who take anti-inflammatory drugs such as aspirin for arthritis pain. In 1988, it was approved by the FDA solely for this use. Yet it is quite legal for physicians to prescribe drugs for indications other than those for which the drug has received FDA approval.
So what protection do pregnant women have when it comes to drugs that are prescribed for another purpose?
Very little, according to Laura Bradbard, spokeswoman for the FDA. “People think we have more authority than we have. We approve a product for a particular indication, based on the data we receive. A physician is free to use a drug for any use he or she feels will benefit a patient. There are no safe drugs. You need to do your homework, ask a lot of questions and speak with your physician about your case and the medications,”
Being fully aware of the facts cited by Gaskin, in August of 2001 Searle sent out a Drug Alert to all physicians warning of the risks of Cytotec and that it should not be used for induction of delivery. This was followed by a Safety Alert issued by the FDA reiterating the risks and prohibitions contained in the Searle letter.
If Cytotec was administered to you without your informed consent being obtained, and there was a resulting serious injury to either yourself or your child, please feel free to contact us at 800-400-8182 or by completing the form on this page.