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.

The US FDA should provoke a conversation between providers and patients about whether naloxone should be co-prescribed with an opioid, according to joint advisory committee, but the panel split on whether labeling is the ideal venue for the message.

The Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees voted 12-11 Dec. 18 that opioid...