FDA Warns Terbutaline Should Not Be Used in Pregnant Women for Prevention or Treatment of Preterm Labor


In late February, the FDA warned 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 (e.g., cardiac arrhythmias, myocardial infarction, pulmonary edema, hypertension, and tachycardia), as well as death.

The agency also warned that 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.

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.

Click here to read the full FDA announcement.