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New Warnings Against Use of Terbutaline to Treat Preterm Labor
This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.
The 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 deemed clinicallyappropriate 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 (ACOG).