FDA requires opioid, OUD medication labels to include naloxone information
The FDA announced that drug manufacturers will now be required to include information about naloxone in prescribing information for opioids and medications to treat opioid use disorders.
FDA Commissioner Stephen M. Hahn, MD, said in a press release that the action “can help further raise awareness about this potentially life-saving treatment for individuals who may be at greater risk of an overdose and those in the community most likely to observe an overdose.”
In a Drug Safety Communication, the agency said labeling should recommend that health care professionals discuss the availability of naloxone with patients who receive opioid pain relievers and medicines to treat opioid use disorder (OUD). The labeling changes also recommend that health care professionals consider prescribing naloxone to patients who are at an increased risk for opioid overdose, including those who have used medications like benzodiazepines or who have a history of OUD or opioid overdose. They should also strongly recommend that providers consider prescribing naloxone to patients prescribed medications to treat OUD.
The FDA also recommended physicians prescribe naloxone to patients receiving opioids whose household members or other close contacts would be at risk for accidental ingestion or overdose.
According to the release, the FDA is requiring that these recommendations be added to prescribing information for opioids and medications to treat OUD, including buprenorphine, methadone and naltrexone.
Hahn said the FDA will use “all available tools” to address the opioid crisis, and that “efforts to increase access to naloxone have the potential to put an important medicine for combatting 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.”
- Press Release
- FDA. FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder. https://www.fda.gov/drugs/drug-safety-and-availability/fda-recommends-health-care-professionals-discuss-naloxone-all-patients-when-prescribing-opioid-pain. Accessed July 24, 2020.