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Opioid Analgesics (Excluding Fentanyl Products) & Duration of Follow-Up and Duration of Use

    Basic Details
    Last Updated
    Wednesday, November 6, 2019
    Health Outcome(s)
    duration of follow-up
    duration of use
    Drug Use
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    FDA held an Advisory Committee (AC) meeting to discuss the definition of opioid-sparing and opioid-replacement analgesics, with particular attention to acute pain in the post-surgical setting. A Sentinel analysis was conducted to understand the variation in opioid use based upon surgical type. Sentinel data indicated that opioid exposure could be reduced among select surgical populations, particularly those undergoing less invasive procedures. However, the analysis also suggested that longer initial prescription durations might be appropriate in some cases and maintaining flexibility in prescribing options is essential to account for variation in opioid analgesic needs by patient as well as procedure.