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Regulatory Focus™ > News Articles > 2020 > 7 > Opioid labeling to include naloxone counseling recommendation

Opioid labeling to include naloxone counseling recommendation

Posted 23 July 2020 | By Kari Oakes 

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.
The labeling change accompanies FDA recommendations that health care professionals adopt a universal policy to discuss naloxone when prescribing any opioid medications or medicines to treat OUD. Healthcare professionals should also consider co-prescribing naloxone with these medications if patients are at increased risk of opioid overdose, says FDA.
The OUD medications mentioned in the labeling requirement include buprenorphine, methadone and naltrexone.
“Today’s action can help further raise awareness about this potentially life-saving treatment for individuals that may be at greater risk of an overdose and those in the community most likely to observe an overdose,” said FDA Commissioner Stephen Hahn, MD, in announcing the changes. He added that increased access to naloxone can place “an important medicine for combating opioid overdose and death in the hands of those who need it most – those at increased risk of opioid overdose and their friends and family.”

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