December 20, 2018
FDA Votes to Support Co-Prescribing Naloxone with Opioids, Consistent with ASA Recommendations
Earlier this week, a Food and Drug Administration (FDA) Committee voted to recommend the co-prescribing of naloxone with an opioid for patients at high risk of an overdose. The recommendation is consistent with the American Society of Anesthesiologists (ASA) position on this issue – a position formally conveyed to the FDA Committee last week. The decision was made by the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee, as they convened to consider options for increasing access to naloxone.
This action is consistent with ASA’s long-held position that naloxone should be made more widely available. In 2016, the Society developed a statement on naloxone, in support making naloxone more accessible to laypersons who might witness an opioid overdose, including first responders and family members and caregivers of high-risk individuals
ASA supports co-prescribing naloxone with an opioid when it is clinically appropriate to do so. Physicians should be educated on the risks and benefits of co-prescribing and be prepared to educate patients and family members on the risks to ensure the appropriate actions are taken in the event of an overdose.
ASA is pleased the FDA will consider the advisory committees’ advice to determine whether to work with opioid manufacturers on the labeling change.