FDA: new opioid labeling includes dose-tapering guidance

  • Food and Drug Administration
  • 12/04/2019

  • Kelli Whitlock Burton
  • Clinical Essentials
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Takeaway

  • The FDA has issued new prescribing requirements for opioid medications used in outpatient settings in response to reports of serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide in opioid-dependent patients.

Why this matters

  • Abrupt discontinuation or rapid dose reductions of opioids in opioid-dependent patients is associated with serious harm and could lead patients to find other sources of opioid analgesics including illicit opioids, such as heroin, and other substances.

Key points

  • Clinicians should not abruptly discontinue opioids in opioid-dependent patients.
  • There is no standard opioid tapering schedule; clinicians should design a patient-specific dose-tapering schedule.
  • For opioid-dependent patients, clinicians should taper by no more than 10%-25% every 2-4 weeks and should consider providing patients with lower dosages.
  • In chronic opioid users, clinicians should establish a multimodal pain management protocol before tapering opioids, including mental health support, if needed.
  • When tapering/discontinuation of opioids in response to suspected substance use disorder (SUD), clinicians should refer the patient for SUD treatment, which may include medication-assisted treatment.
  • The new guidelines include prescribing information on other side effects of opioid withdrawal, including central sleep apnea and drug interactions.