USA – Opioid labeling to include naloxone counseling recommendation

Labels for opioid pain medicines and opioid use disorder (OUD) treatments must now include a recommendation that naloxone availability be discussed as a routine part of prescribing these medicines, says the US Food and Drug Administration (FDA).

“We are requiring the drug manufacturers for all opioid pain relievers and medicines to treat OUD to add new recommendations about naloxone to the prescribing information,” said FDA in a Drug Safety Communication released today.  “This will help ensure that health care professionals discuss the availability of naloxone and assess each patient’s need for a naloxone prescription when opioid pain relievers or medicines to treat OUD are being prescribed or renewed,” said the agency. The Drug Safety Communication also notes that patient medication guides will be updated…