Clinical Connection

FDA requires manufacturers to make opioid analgesic labeling changes

September 9, 2025 · Clinical Team

At the end of July, the U.S. Food and Drug Administration (FDA) issued a safety alert regarding the risks associated with using opioid analgesics (e.g., fentanyl, hydrocodone, methadone, morphine, oxycodone) for longer periods of time. Based on the review of two large studies by a joint committee, the FDA is asking for opioid medicine labels to give clearer guidance to prescribers and patients regarding the risks. The FDA is also requiring a new study to investigate further the benefits and risks of long-term opioid analgesic use. 

The FDA requested labeling changes for opioid analgesics as noted below (this list is not all-inclusive):

• Remove the phrase "extended treatment period" to avoid suggesting that long-term use is safe. 
• Highlight the increased risks with higher doses, and that these risks persist over time. 
• Add the results from the two studies evaluated to medication labels. 
• Clarify that extended-release/long-acting opioid analgesics should only be prescribed when other treatments, including immediate-release opioid analgesics, have failed. 
• Add stronger warnings against quickly reducing the dose or stopping the medication suddenly, which can cause withdrawal, uncontrolled pain, or suicide. 
• Revise the noted interactions with central nervous system depressants to include gabapentinoids (e.g., gabapentin, pregabalin). 
• Modify warnings about certain gastrointestinal effects (e.g., opioid-induced esophageal dysfunction). 

This safety communication should remind health care professionals to:

• Consider an immediate-release formulation of an opioid analgesic as first-line treatment, on an as-needed basis, when medically necessary. 
• Use the lowest effective dose for the shortest duration of time needed. 
• Understand that higher opioid analgesic doses raise overdose risks and serious harm can occur at any stage of treatment. 
• Regularly check if the benefits outweigh the risks. 
• Avoid rapidly reducing or abruptly discontinuing opioid analgesics in patients who may be physically dependent. 
• Talk to patients about the use of overdose reversal medicine, such as naloxone or nalmefene. 

It is important for claimants to follow the guidelines below (and for their caregivers to understand the importance of these guidelines):

• Take opioid analgesics exactly as prescribed. 
• Store medications safely and dispose of unused medicines properly. 
• Be aware that higher doses of opioid analgesics raise the risk of side effects and overdose.   
• Know the symptoms of an overdose and seek emergency help if needed. 
• Discuss overdose reversal options, such as naloxone or nalmefene, with their doctor. 
• Talk to their doctor, pharmacist, or other health care professional about any medication questions.  

If you have any questions, please contact your account manager, clinical liaison, or our Clinical Services team at 1-877-275-7674.