WASHINGTON – The Food and Drug Administration is updating labeling requirements on all opioid medications to emphasize the long-term risks associated with their use.
The agency said the changes will include stronger warnings about not stopping opioids suddenly in patients who may be physically dependent, since doing so can cause serious harm. Labels will also provide new information on overdose reversal medicines, expanded cautions about combining opioids with other nervous system depressants such as gabapentinoids, and details on risks, including toxic leukoencephalopathy and opioid-related problems with the esophagus.
Dr. Bobby Mukkamala, who chairs the American Medical Association Substance Use and Pain Care Task Force, said the updates align with the group’s guidance. “We agree that—if opioid therapy is indicated—physicians should start low and go slow,” Mukkamala said. “We further agree with the FDA that rapid escalations and rapid discontinuation should not occur to avoid patient harm.”
The AMA is urging lawmakers to also remove blanket restrictions on opioid therapy that contradict evidence-based guidelines, expand access to nonopioid pain treatments, and make naloxone more widely available in pharmacies, schools and other public settings.
FDA Commissioner Dr. Marty Makary said in a news release that the new labeling requirements are overdue. “The death of almost one million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment,” Makary said. “This long-overdue labeling change is only part of what needs to be done — we also need to modernize our approval processes and post-market monitoring so that nothing like this ever happens again.”
