FDA requiring labeling changes for opioid analgesics, OUD medicines regarding naloxone

Labeling for opioid analgesics and medicine to treat opioid use disorder (OUD) must be updated to recommend that naloxone availability be discussed as routine part of prescribing these medications, FDA announced Thursday. The labeling changes, which were unveiled in a Drug Safety Communication, advise that health care professionals consider prescribing naloxone when they prescribe medicines for OUD or when prescribing opioid analgesics to individuals at increased risk of 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. “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.”