FDA calls for new labeling on asthma drug terbutaline

By Aimee Keenan-Greene

The U.S. Food and Drug Administration  says change the labels on the injected or infused asthma medicine terbutaline.

It should not be taken by pregnant women to prevent or treat preterm labor longer than 48-72 hours because it can cause serious maternal heart problems and death.

Oral  terbutaline tablets should not be used for prevention or treatment of preterm labor at all.

The FDA is now requiring the addition of a Boxed Warning and Contraindication to the drug prescribing information to warn against these uses.

“Women should be aware that serious and sometimes fatal side effects have been reported after prolonged use of terbutaline in pregnant women,” said Scott Monroe, M.D., director of 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.”

The decision is based on the FDA’s review of post-market safety reports of heart problems and even death associated with terbutaline use for obstetric indications, as well as data from medical literature documenting the lack of safety and effectiveness of terbutaline for preventing preterm labor, and animal data suggesting potential risks.

Terbutaline is FDA-approved to prevent and treat narrowing of the airways (bronchospasm) associated with asthma, bronchitis, and emphysema.

The drug is used off-label for obstetric purposes, including treating preterm labor and treating uterine hyperstimulation.

There is no evidence using  terbutaline to prevent preterm labor improves 'infant outcomes'.

The FDA concluded the risk of serious adverse events outweighs any potential benefit.

The American College of Obstetricians and Gynecologists agrees, discouraging use of terbutaline for preventing preterm labor.