FDA: Oral Terbutaline Side Effects Too Risky for Pregnant Women

Boston, MAIf you are worried that you may have been affected by terbutaline side effects, rest assured you are not alone. Concerns about the use of terbutaline during pregnancy led the FDA to issue strong warnings in February 2011 about the drug's use. Unfortunately, those warnings came too late for some women, who may have suffered serious health problems after terbutaline sulfate was used during their pregnancy.

Terbutaline is approved to treat symptoms of asthma, bronchitis and emphysema. It has not been approved for use during pregnancy, but some medical professionals use it off-label to treat preterm labor (it is not illegal to use a drug off-label). It is available in injectable and oral formulations, and is sometimes administered via a subcutaneous pump.

Concerns about the use of the drug to treat preterm labor arose when a search of the FDA's Adverse Event Reporting System (AERS) found 16 maternal deaths associated with terbutaline use from 1979 to 2009. According to the FDA, of those 16 deaths, three involved terbutaline administered through subcutaneous pump and nine involved oral terbutaline.

In addition to those 16 deaths, the FDA identified 12 situations in which pregnant women suffered a serious cardiovascular event—including hypertension, cardiac arrhythmia and pulmonary edema—linked to terbutaline use between January 1, 1998 and July 2009. Further serious reactions to terbutaline use during pregnancy reportedly include transient hyperglycemia and myocardial ischemia.

When the FDA issued its warning about terbutaline, it noted that the cardiovascular risks now outweigh any potential benefit for women who are given oral terbutaline. Furthermore, the agency warned that injectable terbutaline should not be given on a prolonged basis. In February 2011, the FDA requested a black box warning and contraindication be used on safety information for terbutaline.

The FDA noted that previous warnings about terbutaline use during pregnancy were not heeded by some medical professionals. "Despite labeling changes, FDA's communication to the public, and professional association recommendations, prolonged use of terbutaline continues, with serious and sometimes fatal consequences," Catherine Chew, a spokesperson for the FDA said (02/17/11).

The agency further reported that publications in medical literature have previously reported a lack of both safety and efficacy in using terbutaline to treat recurrent preterm labor.