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Terbutaline Sulfate, sold under the brand names Brethine and Bricanyl, is an asthma medication that has come to be used on an “off-label” basis to treat preterm labor. Premature labor occurs in nearly 20 percent of all pregnancies in the United States and an estimated 1 million women annually are treated with Terbutaline or similar drugs to halt early contractions. The use of Terbutaline for this purpose is not an approved use by the Food and Drug Administration (“FDA”). As early as 1997 the FDA issued its first warning concerning the potential dangers associated with the use of this drug for the treatment and prevention of preterm labor. As noted by the FDA, “The approved labeling for terbutaline…states that the drug should not be used for management of preterm labor.”
Supporting the reasons for not using Terbutaline to manage preterm labor, studies have revealed a link between the use of terbutaline during pregnancy and an increased risk of brain damage and cognitive deficits. These conditions manifest themselves at infancy, continue through adolescence and cause permanent disabilities. A study conducted at Duke University showed that the use of terbutaline may leave the brains of children susceptible to other chemicals present in the environment. The researchers suggest that such an exposure predispose newborns and infants to fall victim to particular ailments and medical conditions in the future.
Consistent with the findings of the Duke University study, the National Asthma Education and Prevention Program has recommended that Terbutaline no longer be given to women with mild intermittent asthma while they are pregnant. The reason for this recommendation was that drugs such as Terbutaline, when administered to pregnant women, also penetrate to the fetus where they affect brain development.
Even the American College of Obstetrics and Gynecology (“ACOG”) warns against the use of terbutaline to prevent preterm labor, when they stated in a Technical Bulletin to it’s members that “no studies have convincingly demonstrated an improvement in survival or any index of long-term neonatal outcome with the use of tocolytic (Terbutaline) therapy. On the other hand, the potential damages of tocolytic therapy to the mother and the neonate are well documented.”
In spite of these facts many physicians continued to treat their pregnant patients with Terbutaline.