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.
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CDER-based program lead by Marta Sokolowska will also handle benzodiazepine and stimulants activities and consult on relevant application assessments.
National Academies report identifies gaps in the existing data – including on the question of whether developing prescribing guidelines would even have an impact on the opioid epidemic.