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Alere Inc. Message Board

  • investrboy2 investrboy2 Feb 18, 2011 9:57 AM Flag

    Terbutaline Black Box

    Possible impact on womens/childrens health division?
    By Joyce Frieden, News Editor, MedPage Today
    Published: February 17, 2011
    Click here to provide feedback

    WASHINGTON -- Injectable terbutaline should not be used to prevent preterm labor or to treat it beyond 48 to 72 hours because of a potential for cardiac problems or death, the FDA announced on Thursday.

    The agency is requiring that a boxed warning and contraindication be added to the terbutaline label for both the injectable and tablet form of the drug.

    Thursday's warning applies to use both in the hospital and outpatient setting, the agency said.

    Terbutaline is approved to prevent and treat bronchospasm associated with asthma, bronchitis, and emphysema, but is sometimes used off-label for treating preterm labor and uterine hyperstimulation.

    Terbutaline also has been used off-label over longer periods of time in an attempt to prevent recurrent preterm labor, according to the FDA.

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