FDA Requiring Opioid Labels to Urge Naloxone Co-prescribing

Alicia Ault

July 23, 2020

In a long-anticipated policy change, the US Food and Drug Administration (FDA) will now require manufacturers of opioids to urge clinicians to
co-prescribe the overdose antidote drug naloxone (Narcan).

The agency is also making the new labeling requirement to makers of opioid use disorder (OUD) treatments, including buprenorphine and methadone.

Two FDA advisory committees urged the agency to make the labeling change in a December 2018 joint meeting. The same month, the US Health and Human Services department recommended co-prescribing of naloxone to all patients at risk for opioid complications, including overdose, as reported by Medscape Medical News.

In addition, as of September 2019, 17 states had enacted naloxone co-prescribing laws, with 7 mandating co-prescribing, 2 suggesting clinicians offer a naloxone prescription, and 8 encouraging co-prescription, according to a RAND Corp study.

The FDA's new drug safety communication is aimed at encouraging prescribers to understand the utility of naloxone and to consider prescribing it to individuals who have a history of overdose or OUD, who are being given an opioid, or who are also using benzodiazepines or other medicines that depress the central nervous system.

"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," FDA Commissioner Stephen M. Hahn, MD, said in a statement.

"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," Hahn added.

The FDA is urging healthcare professionals to discuss the availability of naloxone with all patients when prescribing or renewing an opioid analgesic or medicine to treat OUD, and to consider prescribing the drug when a patient has household members or other close contacts at risk for accidental ingestion or opioid overdose. 

Clinicians should also educate patients and caregivers on how to recognize respiratory depression and how to administer naloxone, the agency said.

In addition, patients should ask prescribers about naloxone availability, learn how to recognize overdose symptoms, and learn how to use naloxone before they are in an emergency situation, the FDA added.

The Medication Guides given to patients will also be updated by manufacturers to include the new information on naloxone.

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