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

Jul 28, 2020

The U.S. Food and Drug Administration (FDA) announced it is requiring that labeling for opioid pain medicine and medicine to treat opioid use disorder (OUD) be updated to help increase availability of naloxone and combat opioid overdoses.

The required labeling changes recommend that health care professionals consider prescribing naloxone when they prescribe medicines to treat OUD. Furthermore, 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. It is also recommended that 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.