The FDA has released new warnings against use of the both the oral and injectable forms of the drug terbutaline for treatment of preterm labor. The drug should not be used in pregnant women for prevention or prolonged treatment of preterm labor in either the hospital or in outpatient settings because of the potential for serious maternal heart problems and death.

Safety Announcement (2-17-2011): “The U.S. Food and Drug Administration (FDA) is warning the public that injectable terbutaline should not be used in pregnant women for prevention or prolonged treatment (beyond 48-72 hours) of preterm labor in either the hospital or outpatient setting because of the potential for serious maternal heart problems and death. The agency is requiring the addition of a Boxed Warning and Contraindication to the terbutaline injection label to warn against this use. In addition, oral terbutaline should not be used for prevention or any treatment of preterm labor because it has not been shown to be effective and has similar safety concerns. The agency is requiring the addition of a Boxed Warning and Contraindication to the terbutaline tablet label to warn against this use.”

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