1. Home
  2. About TMA
  3. TMA Publications

Opioid Labeling Changes Leave Room for Physician Judgment
By Jessica Ridge

drugs-600x400sq

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.  

While prescription opioid overdose is still a measurable and significant cause of fatal opioid overdoses, it’s by far been eclipsed by the use of illicit fentanyl and fentanyl analogues, according to CDC data.  

“The [FDA labeling] adjustments that have been made are more reflective of our collective understanding of problems that existed with the prior opioid prescribing guidelines and are an attempt to get back to more of a clinically relevant approach to prescribing that’s not overly restrictive, but very importantly, emphasizes proper education and appreciation of risk associated with opioid prescribing,” Dr. Tirado said. 

Keep up with TMA’s efforts to quell the abuse of opioids and decrease opioid overdose deaths in the association’s dedicated resource center.

Last Updated On

September 04, 2025

Originally Published On

September 04, 2025

Related Content

Opioids

Jessica Ridge

Reporter, Division of Communications and Marketing

(512) 370-1395
jessica.ridge[at]texmed[dot]org  
Jessica Ridge

Jessica Ridge is a reporter for Texas Medicine and Texas Medicine Today whose work has also appeared in Texas Co-op Power. She grew up in San Antonio and earned a bachelor’s degree in English from the University of Texas at Austin. She lives in Wells Branch with her husband, a quartet of pets, and a houseful of plants.

More stories by Jessica Ridge  

TMA Membership

What could a TMA Membership mean for you, your practice, and your patients?

Join TMA Now

Texas Medicine 

In the challenging 2025 legislative session, the Texas Medical Association preserved access to care, protected physician autonomy, and secured key wins in women’s health, health information technology, and prior authorization in what turned out to be a mostly defensive charge for medicine.  

Dec_24_TM_Cover

 

Get the latest issue.