Is terbutaline FDA approved?
Terbutaline is FDA approved for the treatment of asthma. It is not approved for the treatment of preterm labor in pregnant women. However, doctors have prescribed terbutaline as a preterm labor drug (tocolytic) to more than a million women since it first entered the market in 1974. As the FDA has not approved terbutaline for prevention of preterm labor, this is considered an off-label use of the drug. In 1997, the FDA issued a cautionary letter, warning doctors against prescribing terbutaline for prolonged treatment of preterm labor. Read the full text of the FDA letter.
