The FDA is notifying health care professionals -- specifically, family
physicians and OB-Gyns -- that it is requiring the addition of a new
boxed warning and contraindication to terbutaline's drug labeling to
warn health care professionals about the severe cardiovascular and other
risks these products pose for pregnant women. FDA officials also have
agreed to reclassify terbutaline from a pregnancy category B drug to a
pregnancy category C drug in response to a 2008 citizen petition.
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Terbutaline is approved to prevent and treat bronchospasm associated
with asthma, bronchitis and emphysema, but the drug also has been used
off-label for obstetric purposes, including treating preterm labor and
uterine hyperstimulation. In addition, terbutaline has been used for
longer periods of time to prevent recurrent preterm labor.
However, new safety information reviewed by the FDA indicates that
death and serious adverse reactions, including increased heart rate,
transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary
edema and myocardial ischemia, have been reported after prolonged
administration of oral and injectable terbutaline to pregnant women.
In a Feb. 17 safety alert(www.fda.gov), the FDA acknowledged that
administering terbutaline by injection to a pregnant women in urgent
obstetrical situations within a hospital setting may be appropriate
based on a physician's clinical judgment. However, the agency said
terbutaline administered by injection or by continuous infusion pump
should not be used beyond 48-72 hours. The agency also emphasized that
injectable terbutaline should not be used in the outpatient or home
setting.
Furthermore, the FDA said oral terbutaline is contraindicated for
the treatment or prevention of preterm labor because it has not been
shown to be effective and has safety concerns similar to those
associated with the injectable form of the drug.
The agency advised that women who are taking terbutaline for asthma
or other medical conditions should talk with their physician if they are
pregnant or become pregnant to determine whether use of the drug should
be discontinued.
The Wall