Opioid Labeling Instructions On Naloxone Are Compromise In Co-Prescribing Debate

US FDA says opioid and opioid use disorder treatment labels should suggest providers discuss naloxone availability with patients and caregivers and consider co-prescribing to patients at high-risk of overdose, but it does not mandate co-prescribing, the most aggressive (and costly) option that had been considered.

An ampoule Opioid next to it is a note written in English Opioid epidemic. All around, many tablets and syringes are scattered.
The FDA Drug Safety Communication also recommends prescribing naloxone to patients with children or other household members at risk of accidental ingestion or overdose. • Source: Shutterstock

US Food and Drug Administration has decided to recommend a discussion of naloxone when prescribing an opioid, stopping short of a potentially costly co-prescribing requirement that had been narrowly recommended by an advisory committee.

The agency will require opioid and opioid use disorder product labels to include language recommending “that as a routine part...

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