CYTOTEC: A Major Drug Warning

Okay, I've talked about epidurals, Pitocin, and narcotics, and pointed out their good points and their bad points. When used cautiously, responsibly, and for the right reasons, they might help a laboring mom.

But there is one drug that's becoming very popular and is never okay to use at any time during your pregnancy or labor. That drug is Cytotec.

Cytotec (or misoprostol) is a prescription drug that's used for certain stomach problems such as gastric ulcers. But because one of its side effects is severe cramps or contractions of the uterus, health care providers soon found that it induces labor so effectively that a birth was guaranteed within twelve hours of administration. But it's not a win/win situation. While the provider does get home in plenty of time for dinner, the mom is subjected to a very intense, ongoing labor with contractions occurring one on top of the other until her baby is born.

And then there's the warning label: a very clear, very adamant, and very serious caution that Searle (the manufacturer) puts on every bottle of Cytotec. It warns against the administration of Cytotec to pregnant women because it can cause abortion, premature birth, birth defects, maternal death, or uterine rupture (just to name a few potential problems). Searle even followed this up with a detailed warning letter that they sent to all health care providers in the United States (see below). It is also important to know that as this book goes to press, Cytotec has not been approved by the FDA for the use of inducing or augmenting labor.

The Searle Warning Letter:

August 23, 2000 -- Important drug warning concerning unapproved use of intravaginal or oral misoprostal in pregnant women for induction of labor or abortion.

Dear Health Care Provider:

The purpose of this letter is to remind you that Cytotec administration by any route is contraindicated in women who are pregnant because it can cause abortion. Cytotec is not approved for the induction of labor or abortion.

Cytotec is indicated for the prevention of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin) - induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer.

The uterotonic effect of Cytotec is an inherent property of prostaglandin E1 (PGE1),of which Cytotec is [a] stable, orally active, synthetic analog. Searle has become aware of some instances where Cytotec, outside of its approved indication, was used as a cervical ripening agent prior to termination of pregnancy, or for induction of labor, in spite of the specific contraindications to its use during pregnancy.

Serious adverse events reported following off-label use of Cytotec in pregnant women include maternal or fetal death; uterine hyperstimulation, rupture or perforation requiring uterine surgical repair, hysterectomy or salpingo-oophorectomy; amniotic fluid embolism; severe vaginal bleeding, retained placenta, shock, fetal bradycardia and pelvic pain.

Searle has not conducted research concerning the use of Cytotec for cervical ripening prior to termination of pregnancy or for induction of labor, nor does Searle intend to study or support these uses. Therefore, Searle is unable to provide complete risk information for Cytotec when it is used for such purposes. In addition to the known and unknown acute risks to the mother and fetus, the effect of Cytotec on the later growth, development and functional maturation of the child when Cytotec is used for induction of labor or cervical ripening has not been established.

Searle promotes the use of Cytotec only for its approved indication. Further information may be obtained by calling 1-800-323-4204.

Michael Cullen, MD
Medical Director, U.S.
Searle

Just think about it. If Searle is so aware of the risks and complications associated with Cytotec when it's used off-label (which means when it's not being used for what it was originally intended) that they are compelled to spend lots of time and money on all those letters, then you may be certain that this product is extremely dangerous and the death-cautions are very real to you and your baby.

But the scandal doesn't stop with just label warnings and letters. Ina May Gaskin wrote an article called Cytotec: Dangerous Experiment or Panacea? posted on Salon.com. In it she refers to approximately 20 studies of Cytotec-induced labors (1,958 births total). The results of these labors included two maternal deaths, 16 baby deaths, 19 uterine ruptures, and two hysterectomies.

Health care providers aren't blind - they know all this. And it's shocking! How can a provider, for the sake of his own convenience, one who took an oath to "do no harm," administer this unapproved drug to a laboring woman knowing full well that it will cause uncontrollable contractions and possibly kill her and her baby? No wonder malpractice insurance is so high. I have seen providers "discretely" insert Cytotec vaginally during an exam without the mothers consent or knowledge. This is called "administering medication without a consent" and is illegal. So you must ask your provider if he uses Cytotec and, if he does, tell him that you won't allow it in your labor (preferably in writing). If he insists that it's safe and not all that dangerous, then run, don't walk, out of his office.
--Breck Hawk, RN and Midwife