Salient News reported February 22 that a study conducted at Duke University revealed an increased risk of brain damage and cognitive defects—including autism—in association with the use of Terbutaline during pre-term labor. Along with the potential for infants to be pre-disposed to autism, lay concern over a potential link to aspergers and pervasive development disorder (PDD), as well as autism.
The FDA announced in February that in its view, the risks associated with injectable and oral Terbutaline outweigh the benefits given the potential for serious Terbutaline side effects within the context of pre-term labor and pregnancy. Among them, according to the FDA, are serious maternal heart problems together with the potential for death in association with the use of Terbutaline beyond 48 to 72 hours of prolonged Terbutaline therapy in a hospital or outpatient setting.
Terbutaline was originally approved by the FDA for the treatment of bronchospasms associated with asthma, among other conditions related to the lungs. However, doctors discovered that Terbutaline proved effective for the treatment of pre-term labor.
While manufacturers are not allowed to market a drug for any other use than that for which it is approved by the FDA, doctors have always carried the authority to prescribe drugs off-label as they see fit.
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Others, however, have—and some doctors feel that Terbutaline for preterm labor is over-hyped.
For its part, the FDA in February responded to adverse event reports and post-market safety information that relates to adverse health issues for the mother. There was no reference in the FDA release dated February 17 with regard to impacts on the fetus.
The federal regulator is mandating a black box warning for both injectable and oral Terbutaline in view of the FDA's observation that both can prove harmful to the mother, together with the observation that oral Terbutaline is not effective. It is hoped that the warning will reduce the incidents of Terbutaline sulfate side effects.