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Warning on Use of Terbutaline Sulfate for Preterm Labor
JAMA. 1998;279:9.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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The FDA is alerting physicians and other health professionals to concerns about subcutaneous administration of terbutaline sulfate via infusion pump for off-label use as treatment and prevention of preterm labor (tocolytic therapy). Terbutaline sulfate is approved only for the treatment of asthma, and the approved labeling for terbutaline sulfate injection states that the drug should not be used for the management of preterm labor. The only drug currently approved for tocolytic therapy is ritodrine hydrochloride injection.
Women receiving continuous subcutaneous terbutaline sulfate infusions as tocolytic therapy appear to experience side effects and complications similar to those experienced by women receiving terbutaline and other -sympathomimetics intravenously. Complications include chest pain, tachycardia, dyspnea, and pulmonary edema. At least 1 maternal death occurred during outpatient use of a continuous infusion of terbutaline sulfate by subcutaneous pump. Published studies on the safety of this use are seriously limited by methodologic inadequacies.
In the absence . . . [Full Text of this Article]
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