FDA Requires Opioid Labels to Carry Info on Naloxone

By Kelly Young

Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH

NEJM Journal Watch

The FDA is now requiring the prescribing labels of opioid medications to include recommendations about naloxone. The requirements also apply to drugs used to treat opioid use disorder.

When prescribing or renewing an opioid prescription, clinicians should discuss naloxone availability with patients. They should consider prescribing naloxone to patients who are at increased risk for opioid overdose, and when the patient is living with someone who is at risk for accidental ingestion (e.g., children) or overdose. Clinicians should consider prescribing naloxone to patients at increased overdose risk, even in the absence of a prescription for an opioid or drug to treat opioid use disorder.

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