FDA to require information about naloxone on opioid labels

The FDA will now require information about naloxone, a drug that treats opioid overdose in emergency situations, on the label for all opioid pain medication and medications that treat opioid use disorder. 

Additionally, the FDA is recommending that healthcare providers who are prescribing such treatments discuss naloxone's availability with patients and their caregivers. The agency is also recommending they consider prescribing naloxone to patients receiving medicines that treat opioid use disorder and patients receiving opioid pain medicines who are at increased risk of opioid overdose.

"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," Stephen Hahn, MD, the FDA's commissioner, said in a July 23 news release.

The new rule comes as the FDA and local communities are working to increase access to naloxone to fight opioid overdoses.

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