FDA: Certain Terbutaline Side Effects Outweigh Benefits

Spokane, WAWhen a woman goes into preterm labor, her biggest concern is usually the health of her unborn child, not worrying about things such as terbutaline side effects. Terbutaline is sometimes used off-label to prevent or treat preterm labor, but according to an FDA warning, use of terbutaline during pregnancy or use of terbutaline for preterm labor could put the mother at risk of serious complications.

On February 17, 2011, the US Food and Drug Administration (FDA) warned, "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." At the same time, the FDA announced that oral terbutaline should not be used for any treatment or prevention of preterm labor because it has not yet shown to be effective and has safety concerns similar to those of injectable terbutaline.

When it made the announcement, the FDA noted that a boxed warning, the strongest warning available to the FDA, was being included on injectable terbutaline to warn against using the medication for prevention or prolonged treatment of preterm labor. The FDA's warning noted that as far back as November 1997 the agency issued a Dear Colleague letter, warning healthcare professionals about the potential for serious cardiovascular adverse events that could arise when terbutaline was given to women in labor.

"Publications in the medical literature have reported a lack of safety and efficacy of terbutaline for the treatment of recurrent preterm labor," the FDA noted (02/17/11). "Despite labeling changes, FDA's communication to the public, and professional association recommendations, prolonged use of terbutaline continues, with serious and sometimes fatal consequences."

The FDA's most recent warning came after a review of the Adverse Event Reporting System (AERS) uncovered reports of 16 maternal deaths from the time terbutaline was first marketed until 2009. A further 12 cases of serious cardiovascular events were reported to AERS from January 1, 1998 through July 2009. Included in the cardiovascular events were cardiac arrhythmias, myocardial infarction, pulmonary edema and hypertension. Reports of death and reports of serious cardiovascular events involved terbutaline administered by subcutaneous pump, oral terbutaline in both inpatient and outpatient settings.

Based on that information, the FDA concluded that the risk of serious adverse events outweighs any benefit to pregnant women who receive prolonged injectable terbutaline (longer than 72 hours) or short or long-term oral terbutaline.