New Food and Drug Administration (FDA) labeling requirements for opioid medications reinforces the critical point that physicians’ prescribing decisions must be based on whether the risks for the individual patient outweigh the benefits.
“The FDA’s requirement on opioid medication labeling appropriately focuses on physicians making individualized, informed decisions about opioid prescribing while supporting informed decision-making for patients,” said AMA President Bobby Mukkamala, MD, in a statement.
This update supports a 2022 opioid prescribing guideline issued by the Centers for Disease Control and Prevention (CDC) that underscores shared decision-making and tailors care to the patient.
Here is what’s included in the labeling changes:
- A warning to not stop opioids suddenly in patients who may be physically dependent, as it can cause serious harm.
- Information on medicines that reverse overdose.
- Enhanced cautions about combining opioids with other drugs that slow down the nervous system, such as gabapentinoids.
- New information about toxic leukoencephalopathy.
- Updates about opioid-related problems with the esophagus.
The AMA concurred with the FDA that decisions about starting opioid therapy should be made on whether the benefits outweigh the known risks.
“We agree that—if opioid therapy is indicated—physicians should start low and go slow. We further agree with the FDA that rapid escalations and rapid discontinuation should not occur to avoid patient harm,” said Dr. Mukkamala, who chairs the AMA Substance Use and Pain Care Task Force.
To help support patients with pain, the AMA is calling on lawmakers and other government officials to:
- Remove harmful, one-size-fits-all restrictions on opioid therapy that contradict evidence-based policies from the CDC and the Federation of State Medical Boards.
- Require payers to increase access to nonopioid, multimodal pain care options.
- Increase access to naloxone in pharmacies, schools, universities and public settings.
Learn more about the task force’s evidence-based recommendations.
The AMA and its Substance Use and Pain Care Task Force will continue to support pharmacotherapy and nonpharmacotherapy options based on best medical judgment and individualized patient characteristics, said Dr. Mukkamala.
“This approach has been instrumental in the dramatic reduction in opioid prescriptions and opioid fatalities while maintaining access to care. We will continue to pursue policies with our federal partners that offer appropriate relief to our patients with pain,” he said.
The AMA believes that science, evidence and compassion must continue to guide patient care and policy change as the nation’s opioid epidemic evolves into a more dangerous and complicated illicit drug overdose epidemic. Learn more at the AMA’s End the Epidemic website.
