FDA Warns Against Terbutaline Use for Preterm Labor

The FDA has notified healthcare professionals that injectable terbutaline should not be used in pregnant women for the prevention or prolonged treatment (beyond 48–72 hours) of preterm labor. Additionally, oral terbutaline should not be used for preventing or treating preterm labor because it has not been shown to be effective for this purpose. Death and serious adverse reactions (eg, increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema, and myocardial ischemia) have been reported after prolonged administration of terbutaline to pregnant women. The labeling for terbutaline injection and oral terbutaline have been updated to include Boxed Warnings and Contraindications to warn against these uses and their associated risks.

Terbutaline is approved to prevent and treat bronchospasm associated with asthma, bronchitis, and emphysema. The drug is sometimes used off-label 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.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm243843.htm.