The labelling changes recommended by the US Food and Drug Administration (FDA) are said to help reduce opioid overdoses and deaths
FDA mandates labelling changes for opioid pain medicines. (Credit: Bob Williams from Pixabay.)
The US Food and Drug Administration (FDA) has recommended labelling changes for opioid pain medicines and the medicine used to treat opioid use disorder (OUD) regarding the availability of naloxone.
The labelling changes are said to help reduce opioid overdoses and deaths.
FDA recommended that the health care professionals need to discuss the availability of naloxone as a routine part of prescribing the medicines at the beginning and during the treatment.
Naloxone is a medicine that can be administered by individuals who are with or without any medical training to help reduce deaths caused due to opioid overdose.
FDA commissioner Stephen Hahn said: “Even during this global pandemic, we have continued to prioritize addressing the opioid crisis.
“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.”
FDA announced required labelling changes in Drug Safety Communication
The agency said that the health care professionals should consider prescribing naloxone with the medications patients who are at increased risk of opioid overdose and patients are taking benzodiazepines or other medicines that depress the central nervous system.
They should also consider those who have a history of OUD and those who have experienced a prior opioid overdose.
The medicines for opioid pain and OUD that are mentioned in the labelling requirement, which was announced by the FDA in Drug Safety Communication, include buprenorphine, methadone and naltrexone.
In March this year, the FDA has issued a final rule to require new health warnings featured on cigarette packages and advertisements.