Opioid Labeling Changes Leave Room for Physician Judgment
By Jessica Ridge

The Food and Drug Administration (FDA) is requiring a raft of safety labeling changes to opioid pain medications to support informed decision-making by physicians.  

As well as “to help health care professionals and patients make treatment decisions rooted in the latest evidence,” FDA wrote in their announcement, the changes are intended “to better emphasize and explain the risks associated with [opioid pain medications’] long-term use.” 

The announcement says data from two observational studies FDA conducted, along with public comments and medical research, spurred the updates below, requiring opioid medication labels contain, among other information: 

• A safe discontinuation reminder not to stop opioids suddenly in patients who may be physically dependent, as it can cause serious harm;  

• Clearer information about the estimated risks of addiction, misuse, and overdose during long-term use;  

• Stronger dosing warnings that reiterate higher doses come with greater risks, and that those risks remain over time;   

• Clarified use limits that remove language that could be misinterpreted to support using opioid pain medications over an indefinite duration;   

• Treatment guidance asserting long-acting or extended-release opioids should only be considered when other treatments, including shorter-acting opioids, are inadequate;  

• Overdose reversal agent information; and  

• A drug interaction warning about combining opioids with other drugs that slow down the nervous system, including gabapentinoids. 

Carlos Tirado, MD, a psychiatrist and addiction medicine specialist in Austin, notes while the labeling changes will likely have little impact on the current drivers of opioid overdoses, they do provide a more reasonable framework for practitioners to consider when prescribing opioids. 

Dr. Tirado, co-chair of the Texas Medical Association’s Committee on Behavioral Health, particularly is encouraged by the updates intended to provide clearer information on long-term use risk, use limits, safe discontinuation, and overdose reversal agents.  

“Although these changes are unlikely to make a significant difference on opioid overdoses, the new recommendations provide more confidence for practitioners to be able to meet the needs of patients,” said Dr. Tirado.  

He cautioned, however, against “creating unnecessary fear or stigma in the event people are needing legitimately to be on stable doses of opioids over time.” 

Overly prescriptive and perhaps heavy-handed dosing limits that emerged from previous opioid prescribing guidelines may have been more of a reflection of the sense of crisis and urgency that existed during the height of the opioid crisis, he adds.