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Reglan (Metoclopramide) & Duration of Use

    Basic Details
    Last Updated
    Tuesday, October 5, 2021
    Original Posting Date
    Health Outcome(s)
    duration of use
    Drug Use
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    This Sentinel analysis was initiated to determine length of therapy for oral metoclopramide among pediatric patients aged 0-17 years. Metoclopramide includes a boxed warning for increased risk of tardive dyskinesia (TD) for use > 12 weeks and is not recommended in pediatric patients due to risk of central nervous system complications. Based on the prescription claims data from 2012-2015, an estimated 10% of pediatric patients aged 0-17 years received prescriptions for oral metoclopramide for > 12 weeks, potentially increasing their risk of developing TD. These data provided context for FDA’s assessment of proposed pediatric use by providing information about the potential utilization outside the parameters supported by the available data.