Off-Label Use of Cytotec:
Drawbacks to Popular Labor-Inducing Drug
By Christine Climer
The rate of labor induction has reached an all-time high in the United States, with estimates climbing as high as 33.7 percent of all pregnancies. Inductions may be performed in cases where continuing a pregnancy presents clear health and safety risks to a mother or her fetus.
There are many approaches physicians may take to ripen the cervix and induce labor. One medication that has become popular in recent years for cervical ripening is Cytotec. Typically a pill is broken in half or quarters, and one of the pieces is inserted into the cervix every few hours until the cervix is ready for labor.
Incomplete information
The problem with this is that many women are not given complete information about the medication before they consent to its use. Labor induction is an off-label use of Cytotec. This means that it was developed, researched and approved for another purpose.
The manufacturer’s label for Cytotec only permits it to be used to prevent stomach ulcers in patients who take non-steroidal anti-inflammatory drugs or aspirin on a long-term basis. When a physician uses a drug off-label, he is determining the safety and efficacy himself as opposed to relying on a large, thorough scientific investigation.
A few investigations have been undertaken that compare Cytotec to other medications that are actually approved for the purpose of cervical ripening and labor induction. These studies have demonstrated that although Cytotec appears to be equally effective as the other medications, there are some serious risks. Although women who have been given Cytotec may sometimes progress more quickly than those who have been given some of the other approved medications, they are also more likely to experience certain complications.
Cytotec causes hyperstimulation of the uterus, which can lead to complications including fetal distress, amniotic embolism, uterine rupture, fetal death and postpartum hemorrhage. The risk of uterine rupture is further increased in mothers who have previously had a cesarean delivery.
Manufacturer warnings
Searle, the manufacturer of Cytotec was so concerned about this off-label use that it issued a letter to physicians in August 2000. The letter acknowledged these complications and urged physicians to follow their approved prescribing instructions.
Searle also stated that it “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.”
Get the facts
Before you consent to the use of any medication, make sure you know the facts. You should know:
what all the possible treatment options are
what the medication is, how it works and how much you will be given
how long it takes to work and how long its effects will last
what purpose the FDA approved the medication for
what side effects the medication is expected to have on you and your baby
what complications have been documented to occur with the use of the medication
how much more often the complications occur with this medication as opposed to other medications or no medications at all
If you are ever uncertain, ask your doctor or pharmacist to show you the manufacturer’s prescribing information.
© Christine Climer
Christine Climer is a registered nurse with experience in pulmonary disease, pediatrics, home health and hospice services. See more about Christine.
References
Bennett BB. Uterine rupture during induction of labor at term with intravaginal misoprostol. Obstet Gynecol 1997;89(5 Part 2):832-3.
Blanchette HA, Nayak S, and Erasmus S. Comparison of the safety and efficacy of intravaginal misoprostol (prostaglandin E1) with those of dinoprostone (prostaglandin E2) for cervical ripening and induction of labor in a community hospital. Am J Obstet Gynecol 1999;180:1551-9.
Cytotec Prescribing Information: http://www.pfizer.com/download/uspi_cytotec.pdf
Kolderup L et al. Misoprostol is more efficacious for labor induction than prostaglandin E2, but is it associated with more risk? Am J Obstet Gynecol 1999;180(6 Pt 1):1543-50.
Plaut MM, Schwartz ML, and Lubarsky SL. Uterine rupture associated with the use of misoprostol in the gravid patient with a previous cesarean section. Am J Obstet Gynecol 1999;180:1535-42.
Searle communication to Helath Care Providers. Important Drug Warning Concerning Unapproved Use of Intravaginal or Oral Misoprostol in Pregnant Women for Induction of Labor or Abortion. August 23, 2000. http://www.fda.gov/medwatch/safety/2000/cytote.htm
Tenore JL. Methods for cervical ripening and induction of labor.
Am Fam Physician. 2003 May 15;67(10):2123-8.
