Skip to main content

Higher Dosage Strength Oral and Transmucosal Opioid Analgesic Products & Patient Characteristics and Utilization Patterns

    Basic Details
    Last Updated
    Wednesday, August 7, 2019
    Health Outcome(s)
    patient characteristics
    utilization patterns
    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 better understand the use of higher dose opioid analgesics in the outpatient setting to inform a discussion of potential risk management strategies due to increasing public concern that these products may be more harmful in cases of accidental exposure and overdose, and may be more sought out for misuse and abuse. A Sentinel analysis was conducted to understand the current clinical use of higher dosage strength opioid analgesic products for pain management. Sentinel data indicated that patients on higher dosage strength opioid analgesic products had a higher prevalence of comorbidities, mental health disorders or substance abuse compared to patients on lower dosage strength opioid analgesic products. Moreover, the data showed that use of higher dosage strength products comprised a small proportion of all opioid use and has declined in recent years.