Off-label use of terbutaline to prevent preterm labor could lead to maternal heart problems and death, the FDA warned today in a press release.

The agency advises against prolonged administration of terbutaline beyond 48 to 72 hours in injection or infusion pump formulations, and added that serious adverse events are also associated with terbutaline oral tablet.

Manufacturers are now required to add a boxed warning and contraindications to drug prescribing information.

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

Terbutaline is currently approved to prevent and treat bronchospasm associated with asthma, bronchitis and emphysema, but has been used for obstetric purposes including preterm labor and treating uterine hyperstimulation in hospital settings.

Data from post-market safety reports indicate that the risk of serious adverse events with terbutaline outweighs any potential benefits the drug may have for obstetric purposes.

The FDA advises health care providers and consumers to report any adverse events associated with terbutaline use to MedWatch.