FDA orders update of label change for opioid pain medications

The US Food and Drug Administration (FDA) has announced it is requiring that labelling for opioid pain medicine and medicines to treat opioid use disorder (OUD) be updated to recommend that as a routine part of prescribing these medicines, healthcare 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 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 prioritise addressing the opioid crisis,” said FDA Commissioner Dr Stephen Hahn. “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 labelling changes were announced in a Drug Safety Communication. The labelling changes recommend that healthcare 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. According to the FDA, 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.