December 7, 2011, 10:30:00AM. By Heidi Turner

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Baltimore, MD: The US Food and Drug Administration (FDA) is not the only health organization to issue a warning about terbutaline side effects. In fact, the American College of Obstetricians and Gynecologists has also recommended against long-term use of terbutaline during pregnancy. Specifically, the organization warned about prolonged use of terbutaline for the treatment or prevention of preterm labor.

The American College of Obstetricians and Gynecologists has recommended against the use of injectable terbutaline to prolong labor for more than 48 to 72 hours, supporting a warning issued by the FDA about possible terbutaline side effects. Among the concerns regarding prolonged use of terbutaline during pregnancy are the possible increased risks of cardiac or cardiopulmonary arrhythmias, or pulmonary edema or myocardial ischemia in the mother.

Terbutaline has been used for longer than 72 hours to prolong labor and prevent preterm birth, an off-label use of the medication. The drug was originally approved to treat and/or prevent narrowing of the airways associated with asthma, bronchitis and emphysema.

On February 17, 2011, the FDA issued a warning that the risk of serious adverse events linked to prolonged use of terbutaline outweighed the potential benefits of the medication. The FDA announced that the drug would be given a new Boxed Warning and Contraindication on the label to alert health care professionals about the risks. The FDA noted that pregnant mothers could be at an increased risk of heart problems and even death.

According to the FDA, injectable terbutaline should not be used for more than 48 to 72 hours to treat preterm labor. Furthermore, oral terbutaline is not to be used at all to treat preterm labor because it has not been proven to be effective. Finally, the FDA warned that terbutaline should not be used in the outpatient or home setting.

The FDA had previously warned about the use of terbutaline during pregnancy. In November 1997, the agency issued a Dear Colleague letter to alert health care professionals about the potential risk. Between 1976 and 2009, 16 maternal deaths were linked to the use of terbutaline. A further 12 cases of serious maternal cardiac events were also reported.

In a letter issued February 17, 2011, in response to a citizen petition concerning terbutaline, the FDA noted that the drug has been reclassified from pregnancy risk category B to pregnancy risk category C.

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