Pharmacy Services

Terbutaline Injection and Tablets - New Contraindication for Prolonged Treatment of Preterm Labor

February 22, 2011

FDA issued a Dear Colleague letter in November 1997 warning about the lack of efficacy and safety data of terbutaline used for prolonged treatment of preterm labor. Since then, FDA has reviewed the medical literature and postmarketing data regarding the safety of terbutaline used for obstetrical indications and is warning consumers and healthcare professionals that the serious risk associated with terbutaline injection for prevention or treatment of preterm labor for more than 48-72 hours outweighs the potential benefit to pregnant women. Oral terbutaline has similar safety risks and is not effective for acute or prolonged prevention or treatment of preterm labor.

Terbutaline is a beta-2 agonist labeled to prevent and treat bronchospasm. It is not labeled for treatment of preterm labor. Prolonged use of terbutaline for obstetrical indications can result in maternal cardiovascular complications and death. Since 1976, sixteen maternal deaths associated with terbutaline have been reported. Serious cardiovascular adverse events due to terbutaline were reported in 12 pregnant women since 1998. Based on this information and medical literature reporting the lack of safety and efficacy of terbutaline for treatment of preterm labor, FDA is requiring addition of a Boxed Warning and Contraindication against this use in the terbutaline injection and tablet product labels. There may be situations when a healthcare professional decides short-term, inpatient use of terbutaline injection is clinically necessary in a pregnant woman. However, terbutaline should not be used at home or in outpatient settings.

Report adverse events involving terbutaline to the FDA MedWatch program. Additional information is available through the following links:

Updated
February 22, 2011; University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.