Cytotec

This was taken from a great article from Woman to Woman Childbirth Education. Original site: http://womantowomancbe.wordpress.com/2008/02/17/cytotec-ge-misoprostol-aka-miso/

The obstetric community at large loves this drug. Some doctors refuse to use it at all, and some use it rarely. It’s a little white pill that as one person put it, “turns the cervix into absolute MUSHIE.” That’s the good side. But you know there has to be a bad side. First of all, notice the little picture of the pregnant woman with the big red slash over it. That obviously means it should not be given to pregnant women. The red rectangle on the side is a verbal description of why.
As a pharmacy tech for over 5 years, I’m well acquainted with drugs, their intended effects, and their side effects. All drugs have side effects. Sometimes this effect is so slight that people don’t even notice it; other times it’s overwhelming, or even deadly. Even something as innocuous as Tylenol (acetaminophen) can be deadly. Years ago, I read a story of a college student who accidentally overdosed on acetaminophen and required an emergency liver transplant, because she took several cold medicines and didn’t realize that all of them had acetaminophen in them.
Here is the package insert for Cytotec, taken from the FDA’s website. You should first know what this drug is–it’s to treat ulcers. They found out that it causes uterine contractions, which is why it’s contraindicated for pregnant women. I’ve heard of women inducing their own abortions by getting this medication and taking a few of them. The package insert says that after the 8th week of pregnancy, this drug can cause uterine rupture, but some abortion clinics’ websites I found said they use this drug in 2nd-trimester abortions.
But, after doctors found out that it can ripen an unfavorable cervix, it began to be used popularly in hospitals. I’ve heard more than one report that women are being given this without their knowledge, and/or without informed consent. One of my fellow childbirth educators was the first to tell an OB-resident of the potential dangers of this drug. He had never heard of the risks. Many women are just told that they’ll be given a pill (usually vaginally) to ripen their cervix. They are not told that this drug is contraindicated in pregnant women; nor are they told that it is an off-label use of the drug. What the doctors are doing is completely legal, but I consider it to be unethical not to give these women the full information.
Here is the information from the package insert about labor and delivery:

Cytotec can induce or augment uterine contractions. Vaginal administration of Cytotec, outside of its approved indication, has been used as a cervical ripening agent, for the induction of labor and for treatment of serious postpartum hemorrhage in the presence of uterine atony. A major adverse effect of the obstetrical use of Cytotec is hyperstimulation of the uterus which may progress to uterine tetany with marked impairment of uteroplacental blood flow, uterine rupture (requiring surgical repair, hysterectomy, and/or salpingo-oophorectomy), or amniotic fluid embolism. Pelvic pain, retained placenta, severe genital bleeding, shock, fetal bradycardia, and fetal and maternal death have been reported.
There may be an increased risk of uterine tachysystole, uterine rupture, meconium passage, meconium staining of amniotic fluid, and Cesarean delivery due to uterine hyperstimulation with the use of higher doses of Cytotec; including the manufactured 100 mcg tablet. The risk of uterine rupture increases with advancing gestational ages and with prior uterine surgery, including Cesarean delivery. Grand multiparity also appears to be a risk factor for uterine rupture.

In the year 2000, Searle (this drug’s manufacturer, since taken over by Pfizer) issued a letter of warning to health care providers who might consider using this drug to induce labor or cause an abortion. (My thanks to “americanmum” for reminding me of this!) It says in part:

“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.”

You may be wondering why anybody uses it at all. This drug can ripen the cervix and/or induce labor. In the case of a medically indicated induction, many women have an unfavorable cervix, and the induction is likely to fail, thus necessitating a C-section. If Cytotec is used, and the cervix dilates and effaces, then the woman can have a vaginal birth and be spared a C-section. That’s a good thing. But at what cost?
Some doctors and even some midwives consider this benefit to be so good, and the risk of a ruptured uterus to be so slight, that they will use it. But isn’t that a choice for the patient to make? And shouldn’t the patient be given all of the information? That’s the simple idea behind “informed consent.” I will grant that most women do not have a problem with this drug. I will allow that most babies will survive with few negative sequelae after a Cytotec induction. But these are choices that the mother must make, weighing all the risks and benefits.
Here is a link to Ina May Gaskin’s website, where she has compiled a summary of articles about Cytotec’s use in labor. It has been quite some time since I’ve read it, but I remember that at least one trial was stopped because of the high rate of uterine ruptures in women who had had a C-section. I hope that if you’ve had a C-section, that your doctor will not use this drug on you, but he is legally allowed to use the drug any way he sees fit. The contraindication warning of this drug to pregnant women does not make it illegal to induce a woman with this drug.
In addition to the above article, here are some more true stories of women who have had negative outcomes from the use of this drug. No drug is 100% safe–not even Tylenol. When the benefit outweighs the risk, it makes sense to use it. But it is up to the person who takes the drug to decide the benefit-risk level.
This woman was induced for her 6th birth, and ended up nearly dying from a uterine rupture.
Here is a link to an investigative report that aired in Nashville, about the potential dangers of Cytotec.
Here is a link to a story that aired on CBS news a few years ago.
There are many other stories I could share, but I will let you conduct your own internet searches. The known disastrous side effects are rare but extremely serious. If you believe that Cytotec/misoprostol/miso should not be used on you, then you should discuss this with your doctor or midwife and have that in writing. Some of the doctors and nurses who have talked about this drug have such cavalier attitudes toward it that they may give it to you without even telling you what they’re doing, or giving you an option. But it’s your body, your baby, and should be your choice.