FDA Requiring Labeling Changes for Opioid Pain Medicines, Opioid Use Disorder Medicines Regarding Naloxone

FDA News Release

• For Immediate Release: July 23, 2020

The U.S. Food and Drug Administration today announced it is requiring that labeling for opioid pain medicine and medicine to treat opioid use disorder (OUD) be updated to recommend that as a routine part of prescribing these medicines, health care professionals should discuss the availability of naloxone with patients and caregivers, both when beginning and renewing treatment.

Naloxone is a medicine that can be administered by individuals with or without medical training to help reduce opioid overdose deaths. If naloxone is administered quickly, it can counter the overdose effects, usually within minutes.

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

The required labeling changes announced in a Drug Safety Communication recommend that health care professionals consider prescribing naloxone when they prescribe medicines to treat OUD. Additionally, the labeling changes recommend that health care professionals consider prescribing naloxone to patients being prescribed opioid pain medicines who are at increased risk of opioid overdose, including those who are also taking benzodiazepines or other medicines that depress the central nervous system; those who have a history of OUD; and those who have experienced a prior opioid overdose. A naloxone prescription should also be considered for patients prescribed opioids who have household members, including children, or other close contacts at risk for accidental ingestion or opioid overdose.

The FDA is requiring that these recommendations be added to the prescribing information for opioid pain medicines and medicines to treat OUD, including buprenorphine, methadone and naltrexone. 

The FDA is working with other federal, state and local officials as well as health care professionals, patients and communities nationwide to help increase availability of naloxone and combat opioid overdoses. Patients should talk to their health care professional about how to obtain naloxone according to their state’s requirements or guidelines. The U.S. Department of Health and Human Services has ongoing efforts to fight the opioid crisis and expand the use of naloxone. This includes: better targeting of overdose reversing drugs as part of a 5-Point Strategy to Combat the Opioids Crisis.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.