FDA notified healthcare professionals that neither injectable nor oral terbutaline be used by pregnant women for prevention of preterm labor due to risk of serious maternal heart problems and death.
FDA notified healthcare professionals that injectable terbutaline should not be used by pregnant women for prevention or prolonged treatment (beyond 48 to 72 hours) of preterm labor in either the hospital or outpatient setting because of the potential for serious maternal heart problems and death. 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 carries similar safety concerns.
The agency is requiring the addition of a new boxed warning and contraindication to the terbutaline drug labels.
FDA reviewed postmarketing reports of maternal death and serious cardiovascular adverse events submitted to the Adverse Event Reporting System (AERS) associated with obstetric use of terbutaline.
A search of AERS identified 16 maternal deaths reported between initial marketing of the drug in 1976 and 2009. Three of the 16 cases reported outpatient use of terbutaline administered by a subcutaneous pump, while 9 cases reported use of oral terbutaline alone or in addition to subcutaneous or intravenous terbutaline. Of these 9 cases, 2 reported use of oral terbutaline on an outpatient basis and 7 cases involved inpatient use of oral terbutaline.
FDA identified 12 maternal cases of serious cardiovascular events associated with use of terbutaline that were reported to AERS between January 1, 1998, and July 2009. These events included cardiac arrhythmias, myocardial infarction, pulmonary edema, hypertension, and tachycardia. Three of the 12 cases reported use of the terbutaline administered by subcutaneous pump. Five cases involved use of oral terbutaline alone or in addition to subcutaneous terbutaline. Of these 5 cases, 3 cases involved use of oral terbutaline on an outpatient basis and 2 cases involved inpatient use of oral terbutaline.
Terbutaline is approved to prevent and treat bronchospasm associated with asthma, bronchitis, and emphysema. The drug is sometimes used off-label for acute obstetric uses, including treatment of preterm labor and treatment of uterine hyperstimulation. Terbutaline has also been used off-label over longer periods of time in an attempt to prevent recurrent preterm labor.
To view the FDA Drug Safety Communication, visit: http://bit.ly/fvjstr.