Consumer Health Alert: The FDA is now requiring a Boxed Warning & Contraindication on packaging labels of Terbutaline® cautioning against the use of the injectable drug in the treatment of preterm labor. Death and serious adverse reactions have been reported after prolonged administration of oral or injectable terbutaline to pregnant women.
What’s the problem?
February 17, 2011 – The U.S. Food & Drug Administration (FDA) announced today a warning that injectable terbutaline (trade names Brethine, Bricanyl, Brethaire, Terbulin) 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 extremely serious side effects including:
- increased heart rate
- transient hyperglycemia
- cardiac arrhythmias
- pulmonary edema
- myocardial ischemia
To date, the Adverse Event Reporting System (AERS) has identified at least 16 maternal deaths that were reported between 1976 and 2009. Additionally, the FDA said it has identified at least 12 maternal cases of serious cardiovascular events associated with the use of terbutaline that were reported between Jan. 1, 1998 and July 2009.
Based on this information, FDA said it “has concluded that the risk of serious adverse events outweighs any potential benefit to pregnant women receiving prolonged treatment with terbutaline injection … or acute or prolonged treatment with oral terbutaline.”