The Food and Drug Administration (FDA) has announced that it is requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder (OUD) to include new recommendations about naloxone to the prescribing information.

Naloxone is an opioid antagonist indicated for the complete or partial reversal of opioid depression, and for the diagnosis of suspected or known acute opioid overdose. There are currently 3 FDA-approved formulations of naloxone: a nasal spray, an injectable, and an auto-injector.

The FDA has recommended the new labeling change to reduce the risk of death from opioid overdose by increasing access to naloxone. For patients who are prescribed opioid pain relievers or medicines to treat OUD, health care professionals are recommended to discuss the availability of naloxone, and should consider prescribing it to patients who are at increased risk of opioid overdose, including those taking benzodiazepines or CNS depressants, history of OUD, or history of opioid overdose. Patients at increased risk of overdose should be prescribed naloxone regardless of whether they are receiving a prescription for an opioid pain reliever or medicine for OUD. Health care professionals should also consider prescribing naloxone to patients with household members, including children, or other close contacts who are at risk for accidental ingestion or opioid overdose. 

“Even during this global pandemic, we have continued to prioritize addressing the opioid crisis,” said FDA Commissioner Stephen M. Hahn, MD. “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. 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.”

Patients should speak with their health care professional about how to obtain naloxone according to their state’s requirements or guidelines.

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For more information visit fda.gov.