FDA warns against terbutaline for preterm labor

February 24, 2011

FDA is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor because of the risk for serious maternal heart problems and death.

FDA is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor because of the risk for serious maternal heart problems and death.

In addition, oral terbutaline tablets should not be used for prevention or treatment of preterm labor. FDA is requiring the addition of a Boxed Warning and Contraindication to the drug prescribing information (labeling) to warn against these uses.

According to FDA, death and serious adverse reactions, including increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema, and myocardial ischemia have been reported after prolonged administration of oral or injectable terbutaline to pregnant women.

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 uterine hyperstimulation. Terbutaline has also been used in an attempt to prevent recurrent preterm labor. There is no evidence, however, that use of terbutaline to prevent preterm labor improves infant outcomes. Serious adverse events, including maternal deaths, have been reported with such use in pregnant patients.

“The new FDA warning against the use of terbutaline for preterm labor will require many patients who are currently on the medication to seek alternative therapies,” Mitzi Wasik, PharmD, BCPS, regional director, clinical pharmacy, Coventry Healthcare, Downers Grove, Ill., told Formulary.  “Terbutaline historically has been a common therapy used to prevent preterm labor and will leave many healthcare providers searching for new management options for those in this high-risk population who have previously failed first-line medications.”

According to the March of Dimes, preterm birth occurs in about 12% of all pregnancies in the United States and is the cause of many infant deaths and lingering infant illnesses. Women who are at greatest risk of preterm labor and birth include women who have had a previous preterm birth; women who are pregnant with multiple fetuses; and women with certain uterine or cervical abnormalities.

There are multiple generic versions of terbutaline oral tablets and injectable formulations available. The brand name products were previously discontinued by the companies that made them.