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. There is a potential for serious maternal heart problems. 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 on oral tablets as well.

Terbutaline is approved to prevent and treat bronchospasm (narrowing of airways) 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. The FDA warns this is a dangerous choice.

While it may be clinically deemed appropriate based on the healthcare professional’s judgment to use terbutaline by injection in urgent and individual obstetrical situations, the prolonged use of this drug has resulted in maternal heart problems and death.

Terbutaline should not be used in the outpatient or home setting, the FDA said.