FDA warns: Don’t use terbutaline
for preterm labor

Prolonged use can be life-threatening to pregnant women

FEBRUARY 17, 2011—Injectable terbutaline should not be used for prevention or prolonged treatment of preterm labor in pregnant women because of the potential for serious maternal heart problems and death, according to a warning issued February 17 by the US Food and Drug Administration. The agency also warned that the oral formulation of terbutaline should not be used for prevention or any treatment of preterm labor because of similar safety concerns and the fact that it has not been shown to be effective.

The FDA decided to require that a boxed warning and contraindication be added to terbutaline drug labels after reviewing safety information from the medical literature and from post-marketing safety reports of terbutaline used for obstetrical indications.