On February 17, 2011, the FDA issued a warning that injectable terbutaline should not be used in pregnant women for more than 48 to 72 hours to prevent preterm labor. The agency warned at the time that pregnant women faced a risk of serious heart problems, possibly resulting in death, and noted that a boxed warning would be added to the injection label.
"In addition," the FDA noted, "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 FDA further noted that in urgent situations in the hospital, doctors could use their judgment in administering terbutaline, the drug should not be used in an outpatient or home setting.
The FDA issued the warning after reviewing post-marketing reports of maternal death and cardiovascular adverse events associated with the use of terbutaline in pregnant women. The adverse events reports included information of 16 cases of maternal death from 1976 through 2009, including nine cases of death associated with oral terbutaline.
In November 1997, the FDA issued a Dear Colleague letter, warning about the long-term use of subcutaneous administration of terbutaline. Since that time, however, the FDA received an additional 12 reports of serious cardiovascular events associated with the use of terbutaline during pregnancy.
Terbutaline is approved to treat symptoms of asthma and bronchitis, but is not approved to treat preterm labor. The drug is marketed as Brethine and Bricanyl, according to the Los Angeles Times (02/18/11).
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Despite the FDA warning physicians in the past that the long-term use of terbutaline for preterm labor was both not effective and potentially dangerous, the agency noted that such use of terbutaline still occurs, "with serious and sometimes fatal consequences."