FDA warns against using terbutaline in preterm labor

February 24, 2011

The United States Food and Drug Administration (FDA) has mandated a label change for terbutaline that warns against off-label use of the drug to prevent and treat preterm labor because of potentially fatal maternal heart problems.

The U.S. Food and Drug Administration (FDA) has mandated a label change for terbutaline that warns against off-label use of the drug to prevent and treat preterm labor because of potentially fatal maternal heart problems.

The new Boxed Warning and Contraindications alerts healthcare professionals not to give injectable terbutaline for prevention or prolonged treatment (ie, longer than 48 to 72 hours) of preterm labor and not to give oral terbutaline for prevention or treatment of preterm labor.

Based on a review of new data from postmarketing safety reports and the medical literature, FDA concluded that the risk of adverse events to the mother-including increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema, myocardial ischemia, and death-outweighs any potential obstetrical benefit of the drug. The label change is consistent with statements from the American College of Obstetricians and Gynecologists.

Terbutaline-which is approved to prevent bronchospasm accompanying asthma, bronchitis, and emphysema-is sometimes used off label to treat preterm labor and uterine hyperstimulation and, over longer periods, to prevent recurrent preterm labor.