Off-Label Use of Cytotec: Drawbacks to Popular Labor-Inducing
Drug
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.
This article is intended for educational purposes only. It is
not intended to serve as medical advice or as a substitute for
professional medical advice and should not be interpreted as
recommendation for treatment. If you have questions or concerns
regarding your physical or mental health or the health of your
child, please seek assistance from a qualified health care
provider before using any health information.