Based on new safety information reviewed by the FDA, the agency has notified health care professionals that is it requiring the addition of a new Boxed Warning and Contraindication to the terbutaline drug label, warning against use of injectable terbutaline in pregnant women for prevention or prolonged treatment (beyond 48-72 hours) or premature labor. Likewise, oral terbutaline should not be used for prevention or any treatment of premature labor, due to lack of proven efficacy and has similar safety concerns.
The associated adverse events have been found to outweigh any potential benefit to pregnant women. These potential adverse events include increase heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema, myocardial ischemia, and death.
Terbutaline is a B2-adrenergic agonist approved for the prevention and treatment of bronchospasm associated with asthma, bronchitis and emphysema. It has also been used off-label for acute obstetrics, including treating premature labor and uterine hyperstimulation; and over longer periods in an attempt to prevent recurrent premature labor.
Terbutaline is available on the Egyptian market under the tradenames Aironyl, Butaline ER, and Bricanyl.