The US Food and Drug Administration announced today that it requires the labeling of opioid pain relievers and medications to treat opioid use disorder (OUD) to be updated to recommend that, as a routine part of prescribing these Medications, healthcare professionals discuss the availability of naloxone with patients and caregivers, both when starting and renewing treatment.

Naloxone is a medication that can be administered by people with or without medical training to help reduce deaths from opioid overdose. If naloxone is given quickly, it can counteract the effects of an overdose, usually within minutes.

“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 raise awareness of this life-threatening treatment for people who may be most at risk of an overdose and those in the community most likely to experience an overdose. We will use all available tools to address this crisis. , and we know that efforts to increase access to naloxone have the potential to put an important drug to combat opioid overdose and death in the hands of those who need it most, those at increased risk for opioids. and relatives “.

The required labeling changes announced in a Medication Safety Communication recommend that healthcare professionals consider prescribing naloxone when prescribing medications to treat OUD. In addition, labeling changes recommend that healthcare professionals consider prescribing naloxone for patients who are prescribed opioid pain relievers who are at increased risk for opioid overdose, including those who are also taking benzodiazepines or other medications that depress Central Nervous System; those who have an OUD history; and those who have experienced a previous opioid overdose. A prescription for naloxone should also be considered for prescription opioid patients who have household members, including children or other close contacts at risk of accidental ingestion or opioid overdose.

The FDA requires that these recommendations be added to the prescribing information for opioid pain relievers and medications to treat OUD, including buprenorphine, methadone, and naltrexone.

The FDA is working with other federal, state, and local officials, as well as health professionals, patients, and communities across the country to help increase the availability of naloxone and combat opioid overdoses. Patients should speak to their healthcare professional about obtaining naloxone according to their state’s requirements or guidelines. The US Department of Health and Human Services is making continuous efforts to combat the opioid crisis and expand the use of naloxone. This includes: better targeting of drugs to reverse overdose as part of a 5-point strategy to combat the opioid crisis.

The FDA, an agency within the US Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and safety of medicines, vaccines, and other biological products for human use and medical devices for humans and vets. The agency is also responsible for the security of the supply of food, cosmetics, dietary supplements, products that emit electronic radiation from our country and for regulating tobacco products.

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