Injectable Terbutaline Should Not Be Used to Treat Pregnant Women, FDA Warns

February 28, 2011 11:03 AM Topics: Patient safety

FDA warns health care providers and patients 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. In addition, FDA warns, 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. Death and serious adverse reactions, including increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema, and myocardial ischemia have been reported after prolonged administration of oral or injectable terbutaline to pregnant women. FDA is requiring the addition of a boxed warning and contraindication to both the terbutaline injection label and the terbutaline tablet label to warn against this use.

FDA explains that terbutaline, approved to prevent and treat bronchospasm (narrowing of airways) associated with asthma, bronchitis, and emphysema, 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. Based on the FDA review, the FDA has concluded that the risk of serious adverse events outweighs any potential benefit to pregnant women receiving prolonged treatment with terbutaline injection (beyond 48-72 hours), or acute or prolonged treatment with oral terbutaline.

More information is available in an FDA Drug Safety Communication.