Opioids
Loren Bonner
FDA intends to add new warnings to all opioid pain medications to emphasize the risks of long-term use, including a summary of study results showing the potential for addiction, misuse, and overdose during long-term use; stronger warnings about higher doses; and more.
The labeling change, however, has worried some as it could be perceived as a harkening back to the days of the 2016 CDC opioid guidelines that caused providers and payers to cut patients off inappropriately, resulting in suicides and patients with pain going to the illicit market to get medications.
“The ‘one-size-fits-all’ mentality typically doesn’t work and often leads to poorer health outcomes,” said Emily Leppien, PharmD, from Binghamton University School of Pharmacy and Pharmaceutical Sciences. “This may also hold true for the new ‘one-size-fits-all’ labeling requirements outlining the associated risks of long-term opioid therapy.”
The 2016 CDC guidelines—which were simply intended to “guide” therapy—turned into policies and practices that, for example, encouraged hard limits and, in some cases, resulted in abrupt tapering of opioid drug doses.
FDA’s new labeling requirements do recognize that providers must make individualized, informed decisions when prescribing opioid therapy for patients. As complex as it is, chronic pain management often requires this individualized, multimodal approach, combining different treatment modalities.
“The decision to initiate, adjust, or continue opioid therapy should be based on if the benefits outweigh associated risks,” said Leppien. “These decisions should be made with the understanding that each patient’s circumstances, including pain intensity, functional impairment, comorbidities, and psychological state, are unique.”
She agreed that there are significant risks of using long-term opioid therapy, but also risks associated with untreated or undertreated pain.
FDA said the updated labeling change reflects data from two large FDA-required observational studies—postmarketing requirements 3033-1 and 3033-2. These studies revealed new data on how long-term opioid use can lead to serious adverse effects.
“After reviewing those results, public comments, medical research and recognizing the absence of adequate and well-controlled studies on long-term opioid effectiveness, the FDA decided to require safety labeling changes to help health care professionals and patients make treatment decisions rooted in the latest evidence,” FDA stated.
Slow tapers
FDA cautions against rapid tapering of opioids, and the new labeling on opioids will include a reminder not to stop opioids suddenly in patients who may be physically dependent, as it can cause serious harm.
When CDC updated the controversial 2016 CDC opioid guideline for chronic pain in 2022, they also reinforced conservative tapers in that updated guidance.
CDC also promoted tailored care for patients in the 2022 guidance through shared decision making between patients and their care teams, including pharmacists.
FDA noted that it has also required an additional prospective, randomized, controlled clinical trial to directly examine the benefits and risks of long-term opioid use. The two observational studies FDA used to determine the new labeling seemed to only focus on the harms. ■
FDA’s opioid labeling changes will include the following updates:
- Clearer risk information: A summary of study results showing the estimated risks of addiction, misuse, and overdose during long-term use.
- Dosing warnings: Stronger warnings that higher doses come with greater risks and that those risks remain over time.
- Clarified use limits: Removing language that could be misinterpreted to support using opioid pain medications over an indefinitely long duration.
- Treatment guidance: Labels will reinforce that long-acting or extended-release opioids should only be considered when other treatments, including shorter-acting opioids, are inadequate.
- Safe discontinuation: A reminder not to stop opioids suddenly in patients who may be physically dependent, as it can cause serious harm.
- Overdose reversal agents: Additional information on medicines that can reverse an opioid overdose.
- Drug interactions: Enhanced warning about combining opioids with other drugs that slow down the nervous system—now including gabapentinoids.
- More risks with overdose: New information about toxic leukoencephalopathy—a serious brain condition that may occur after an overdose.
- Digestive health: Updates about opioid-related problems with the esophagus. ■