FDA wants terbutaline to carry boxed warning label

SILVER SPRING, Md. — An asthma drug widely available as a generic should not be used for preventing or treating preterm labor in pregnant women, the Food and Drug Administration warned.

The drug, terbutaline, is available as a tablet and an injectable. The drug does not have FDA approval for the treatment or prevention of preterm labor, but often is prescribed off-label for pregnancy-related issues. The agency said it had received reports of dangerous side effects in mothers who had taken the drug for such reasons, including death, but that there was no evidence that use of the drug improved outcomes for infants. The agency is requiring the drug to carry a boxed warning label, the strongest form of labeling, warning against use of the drug for complications related to pregnancy.

“Women should be aware that serious and sometimes fatal side effects have been reported after prolonged use of terbutaline in pregnant women,” FDA Division of Reproductive and Urologic Products director Scott Monroe said. “It is important for patents and healthcare professionals to consider all the potential risks and known benefits of any drug before deciding on its use.”

Under the law, a drug company only can market a drug to prescribers and consumers for the uses it has FDA approval for, but doctors still can prescribe it for unapproved uses.