SILVER SPRING, Md., Feb. 17, 2011 /PRNewswire-USNewswire/ — The
U.S. Food and Drug Administration is warning that terbutaline
administered by injection or through an infusion pump should not be
used in pregnant women for prevention or prolonged (beyond 48-72
hours) treatment of preterm labor due to the potential for serious
maternal heart problems and death. In addition, oral terbutaline
tablets should not be used for prevention or treatment of preterm
labor. The FDA is requiring the addition of a Boxed Warning and
Contraindication to the drug prescribing information (labeling) to
warn against these uses.
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Terbutaline is FDA-approved to prevent and treat narrowing of
the airways (bronchospasm) associated with asthma, bronchitis, and
emphysema. The drug is used off-label for obstetric purposes,
including treating preterm labor and treating uterine
hyperstimulation. Terbutaline has also been used in an attempt to
prevent recurrent preterm labor. There is no evidence, however,
that use of terbutaline to prevent preterm labor improves infant
outcomes. Serious adverse events, including maternal deaths, have
been reported with such use in pregnant patients.
“Women should be aware that serious and sometimes fatal side
effects have been reported after prolonged use of terbutaline in
pregnant women,” said Scott Monroe, M.D., director of FDA’s
Division of Reproductive and Urologic Products. “It is important
for patients and health care professionals to consider all the
potential risks and known benefits of any drug before deciding on
its use.”
The FDA is aware that administration of terbutaline by injection
to pregnant women is used in hospital settings in certain urgent
situations. The FDA warning relates to safety concerns about the
prolonged use of terbutaline injection beyond 48-72 hours, and
against any use of oral te
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