Pregnant Women Beware: Cytotec Alert

     You are responsible for making choices about your pregnancy, labor and birth. Not educating yourself or making choices and leaving it all up to the experts, whether doctor or midwife, is still making a choice. Whatever information your caregiver does or does not give you, you, your baby and your family are the ones that have to live with the consequences.

     Cytotec or misoprostol, is one area that it is extremely important to be informed about and legally in most states, doctors and midwives are not required to get informed consent before using this drug. Cytotec came on the market in 1988 as an ulcer drug. Through a loophole in FDA policy, once a drug is approved it can be used for anything and somehow it was discovered that Cytotec would induce or start labor. In fact it is now the “agent of choice”, according to the American College of Obstetricians and Gynecologists (ACOG) chairman.

     One reason for this is cost, fifty cents a pill compared to $98-168 for a dose of prostaglandin gel used to ripen the cervix prior to induction for better results. Cytotec ripens the cervix which Pitocin doesn’t do though some Cytotec inductions still require Pitocin to complete them. In a Pitocin induction, 10mu of Pitocin is added to 500ml of IV fluid and this is piggybacked into a regular IV. This allows the Pitocin to be regulated separately and to be turned off if needed. The placenta has a two minute oxygen reserve. Contractions should not be closer than two minutes or last an unusually long time or this reserve is depleted which puts the baby at risk of repiratory distress. Pitocin can be turned down to slow contractions if they become too strong or close. Cytotec comes in a 100mcg tablet that, though unscored, is often cut into pieces for labor induction. It can be used orally or inserted vaginally. Unfortunately there is no way to “turn it off” once it’s been given. The lowest dose normally is 25mcg and even that has ruptured uteruses and killed mothers and babies. Even “crumbs” have caused too strong contractions in susceptible women. Sometimes they try to flush out the pill if inserted vaginally or use other drugs to counteract it but neither technigue has been very sucessful.

     In June of 2000, Searle changed the Cytotec package insert to include a warning against using it in pregnancy or birth. this insert says, ” Cytotec may cause the uterus to rupture if it used to induce labor. Uterine rupture may result in severe bleeding, extended hospitalization, surgery, infertility and death.” In August of 2000, Searle sent a letter to 200,000 healthcare providers saying that Cytotec “in contraindicated in pregnancy.” About one-third of hospitals restricted use after this letter but in 2010 Cytotec is in wide use for labor induction in the US and around the world.

     When I called Searle in 2004 to get a copy of the letter, it had been deleted from their files. Pfiser Global Pharmaceuticals now handles Cytotec and the package insert quotes are from their 2003 label. You can call Pfiser at 1-800-323-4204 for the complete package insert or ask your hospital pharmacist. In November of that year, ACOG petitioned the FDA to remove the letter and rescind the warning label. However in May 2005 the FDA issued an alert that makes clear

1. Cytotec should not be used for labor induction.

2. But , if it is used for induction against the FDA recommendation, the patient has the right to fully informed consent which must include the risks listed on the package insert. Failure to get informed consent results in serious legal exposure for the healthcare providers.

Here are several quotes from the package insert.

     “Cytotec administration to women who are pregnant can cause abortion, premature birth, birth defects and uterine rupture.”

     “Several reports in the literature associate the use of misoprostol during the first trimester of pregnancy ( for ulcers or to induce an abortion that failed) with skull defects in the baby as well as cranial nerve palsies, facial malformations and limb defects.”

     A major adverse effect of the obstetrical use of Cytotec is the hyperstimulation of the uterus which may progress… to uterine rupture or amniotic fluid embolism… severe genital bleeding, shock, fetal bradycardia(low heart rate) and fetal and maternal death have been reported.”

     “The effects of Cytotec on later growth, development and functional maturation of the child when Cytotec is used for cervical ripening or induction of labor have not been established.

     Marsden Wagner, MD, is the former director of women’s and children’s health for the World Health Organization. He has become an expert witness in legal cases involving Cytotec, sixteen cases as of 2004. Many women and babies are dying and others are being compromised for life. All the cases include a gag rule so the public never learns about them.

     Please see my book, Amazing Birth Stories, for a more complete article on this issue and a copy of the Searle letter. Midwifery Today magazine is covering this issue, and you can search by Cytotec or misoprostol. Please don’t let yourself or your baby become a guinea pig in this unacknowledged experiment.