Naloxone Mandate In Opioid Labels Divides US FDA Panel, Even As It Wants Patient Conversations
Advisory committee members vote narrowly in favor of labeling opioids with a recommendation to co-prescribe naloxone, but more agree that the goal is to facilitate patient-provider dialogue about overdose risks.
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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.
The acting commissioner's statement is intended to clarify "persistent misunderstanding" about the label for the opioid overdose rescue medication's injectable formulation.
Naloxone distribution programs ask that the cheaper generic injectable formulation have the same community-use language in its label as the nasal spray and auto-injector so they can maximize their distribution efforts.