Cervidil (FDA approved for vaginal use)
Cytotec / Miso (On-label contra-indicated)
Once a drug is approved by the FDA for a specific medical indication and put on the market, there is absolutely nothing to prevent any doctor from using that drug for any indication, in any dose, for any patient he or she chooses. Since the label of the drug contains the indications approved by the FDA, this is called “off-label” use of a drug.
The Misoprostol (Cytotec) warning paper that comes with its packaging – a product designed for stomach ulcers and now used every day around the world to induce labor – generally reads: “Misoprostol administration to women who are pregnant can cause abortion, premature birth, or birth defects. Uterine rupture has been reported when Misoprostol tablets were administered in pregnant women to induce labor or to induce abortion beyond eighth week of pregnancy.”
Cytotec and the FDA
The Food and Drug Administration (FDA) describes its role as a regulatory agency, publishing rules that establish or modify the way foods, drugs, biologics, cosmetics, radiation-emitting electronics, and medical devices should be used. Much of the FDA’s prestige stems from the work of Dr. Frances Kelsey, a compliance officer in the early 1960s. She became an international hero when she withstood great pressure by a prominent German drug company that wanted quick approval for the drug thalidomide to be used for insomnia and morning sickness in pregnant women in the US. The manufacturer insisted it was safe, pointing out that 20 countries had already approved the drug. Demanding more testing on the proposed use for pregnant women, Dr. Kelsey’s insistence on scientific rigor saved countless American women from giving birth to children afflicted by phocomelia (missing limbs and other major malformations). Her stubborn stand was vindicated when thousands of babies were born with phocomelia in countries where thalidomide was approved. This tragic development led to the passage of Congressional laws attempting to strengthen the FDA’s control of drug experimentation on humans and the way new drugs are regulated.
However, Dr. Kelsey’s important work did not prevent the practice of prescribing drugs for an unapproved indication or in an unapproved age group, unapproved dose, or unapproved form of administration—what is called “off-label use.” Contrary to popular notion, it is legal in the US and in many other countries to use drugs off-label. What most people may not know is that with the exception of oxytocin and Cervidil, many drugs used in obstetrics are prescribed off-label, primarily because there is little or no incentive for a drug company to make an application or carry out experiments for a drug intended for pregnant women.
Cytotec/Misoprostol Induction and Off-Label Use
As early as 2000, G.D. Searle, the original manufacturer of Cytotec, had already received reports of a long list of adverse effects from use of the drug for induction of labor. The medical literature stated that Cytotec often hyperstimulated the uterus, increased the incidence of thick meconium, caused prolonged contractions in some women more than 20 hours after the last dose, was sometimes associated with more third- and fourth-degree lacerations than other induction drugs, caused massive postpartum hemorrhage that couldn’t be stopped without hysterectomy, was associated with maternal death from amniotic embolism, could rupture an unscarred uterus even with a minimal or moderate dose, caused fetal distress, was associated with a high incidence of babies sent to the neonatal intensive care unit, and was associated with high cesarean rates. Even so, Cytotec’s popularity with many obstetricians was already well established, despite the still experimental status of the drug and the manufacturer’s warning.
The Searle company issued a letter in August of that year addressed to all birth professionals, urging them never to use it for induction, listing the dangers: maternal or fetal death, uterine hyperstimulation, amniotic fluid embolism, severe vaginal bleeding, retained placenta, shock, fetal bradycardia, severe pelvic pain, uterine rupture, and babies requiring NICU.
Two months after the release of the Searle letter, the American College of Obstetricians and Gynecologists (ACOG) sent a letter to the FDA and a press release to the media, insisting that any adverse effects that had been reported to the FDA or Searle had been the result of incorrect use of Cytotec and ACOG requested (in what it called a “citizen petition”) that the FDA require Searle to retract its warning letter. The FDA has so far declined to fulfill this request.
The FDA has stated that its 2005 Alert is sufficient for protecting pregnant women against the risks associated with Cytotec/misoprostol and has thus declined the requests made that would make it easier for women whose doctors might prescribe Cytotec/Miso for induction to get some idea of how many people have suffered adverse effects from its use.
When obstetricians using Cytotec induction are confronted about their willingness to use a drug “off-label,” they inevitably answer: “We use drugs off-label all the time.” There are several serious problems with this answer. In reality, using Cytotec for induction is not “off-label” at all—it is “on-label contraindicated.” On the Cytotec label it is explicitly written that this drug is contraindicated for use on pregnant women, indicating possible serious risks from such use. “On-label contraindicated” is a whole different level of risk-taking.
The following list of organizations do and do not recommend Cytotec/misoprostol for labor induction:
- American College of Obstetricians and Gynecologists (ACOG)
Does not recommend:
- U.S. Food and Drug Administration
- Best scientific opinion—Cochrane Database
- Searle (manufacturer of Cytotec)
- Society of Obstetricians and Gynaecologists of Canada
- British Royal College of Obstetricians and Gynecologists
- All obstetric organizations in Scandinavia
- FIGO (International Federation of Gynecology and Obstetrics)
- World Health Organization
- Obstetric organizations and drug regulatory agencies in many other countries
A word on Pitocin, with more to come:
Between 1998-2011, in my own Supported Birth classes, there were only 13 women who got through labor on Pitocin without an epidural. Eight of them had doulas. Five of them had super short labors.
Then suddenly, between 2012 and mid 2013, there were FIVE women who had Pit-only labors. In my curiosity to see why the sudden increase, I came across the following extremely disturbing facts.
Here is what I found in my own inadvertent research:
Of the 18 Pit-only labors between 1998-2013, 11 of them were extremely short, intense, due to what can be called “hyperstimulation” of the uterus. The labors were 2, 3, or 4 hours long, with one at 5 hours. Some involved the mother’s membranes being ruptured as well.
Of these 11 short, Pit-induced and augmented labors, four had severe postpartum hemorrhages, one characterized as “the placenta came out in pieces” and one had severe tearing due to fetal distress requiring the mother to get the baby out fast.
This means, in my tiny study of my own students, about 2/3 of the women on Pit had these hyperstimulated labors, and about 1/2 of those hemorrhaged.