FDA requires naloxone info on opioid labels

FDA announced that labeling for opioid analgesics and medicine to treat opioid use disorder (OUD) must be updated to recommend that naloxone availability be discussed as a routine part of prescribing these medications.

The labeling changes, which were unveiled in an FDA Drug Safety Communication, advise that health professionals consider prescribing naloxone when they prescribe medicines for OUD or when prescribing opioids to individuals who are at an increased risk of an opioid overdose. Additionally, a prescription for naloxone should be considered for individuals prescribed opioids who have household members, including children, or other close contacts who are at risk for accidental ingestion or opioid overdose.

FDA is mandating these recommendations be added to the prescribing information for opioid analgesics and medicines to treat OUD, including 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 M. Hahn, MD, in a press statement. "We will use all available tools to address this crisis, and we know efforts to increase access to naloxone have the potential to put 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."