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From the Food and Drug Administration
January 7, 1998

Warning on Use of Terbutaline Sulfate for Preterm Labor

Author Affiliations

Copyright 1998 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.1998American Medical Association

JAMA. 1998;279(1):9. doi:10.1001/jama.279.1.9-JFD71011-2-1

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.

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