The
U.S. Food and Drug Administration (FDA) is warning the public that injectable terbutaline should not be used in
pregnant women for prevention or prolonged treatment (beyond 48-72 hours) of
preterm labor in either the hospital or outpatient setting because of the
potential for serious maternal heart problems and death. The agency is
requiring the addition of a Boxed
Warning and Contraindication to the terbutaline
injection label to warn against this use. In addition, oral terbutaline
should not be used for prevention or any treatment of preterm labor because it
has not been shown to be effective and has similar safety concerns. The agency
is requiring the addition of a Boxed Warning and Contraindication to
the terbutaline tablet label to warn against this use.
Terbutaline
is approved to prevent and treat bronchospasm (narrowing of airways) associated
with asthma, bronchitis, and emphysema. The drug is sometimes used off-label
(an unapproved use) for acute obstetric uses, including treating preterm labor
and treating uterine hyperstimulation. Terbutaline has also been used off-label
over longer periods of time in an attempt to prevent recurrent preterm
labor.
Although
it may be clinically deemed appropriate based on the healthcare professional's
judgment to administer terbutaline by injection in urgent and individual
obstetrical situations in a hospital setting, the prolonged use of this drug to
prevent recurrent preterm labor can result in maternal heart problems and
death. Terbutaline should not be used in the outpatient or home setting.
The
decision to require the addition of a Boxed Warning and Contraindication is
based on new safety information received and reviewed by the FDA. Specifically,
FDA has reviewed postmarketing safety reports of terbutaline used for
obstetrical indications, as well as data from the medical literature. These
label changes are consistent with statements from the American College of
Obstetricians and Gynecologists.
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