THURSDAY, Feb. 17 (HealthDay News) -- 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 by the U.S. Food and Drug Administration. The agency also warned that oral 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 agency 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.
Upon reviewing the new information, the FDA concluded that the risk of serious adverse events, such as increased heart rate, transient hyperglycemia, myocardial ischemia, and death, outweighs potential benefits to pregnant women receiving prolonged treatment with injectable terbutaline or acute or prolonged treatment with oral terbutaline.
"Although it may be clinically deemed appropriate based on the health care professional's judgment to administer terbutaline by injection in urgent and individual obstetrical situations in a hospital setting, the prolonged use of this drug to prevent recurrent preterm labor can result in maternal heart problems and death," according to the FDA safety announcement.