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New Warning - Ditropan XL may cause facial & throat swelling

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  • New Warning - Ditropan XL may cause facial & throat swelling

    Ditropan XL (oxybutynin chloride) tablets
    Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2011

    WARNINGS
    Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, oxybutynin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.

    PRECAUTIONS
    Information for Patients
    Patients should be informed that oxybutynin may produce angioedema that could result in lifethreatening airway obstruction. Patients should be advised to promptly discontinue oxybutynin therapy and seek immediate medical attention if they experience edema of the tongue, edema of the laryngopharynx, or difficulty breathing.
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