FDA Issues Sweeping Opioid Label Changes to Strengthen Safety

Why the FDA changed its opioid labeling requirements

The new labeling requirements outlined by the FDA are intended to provide an emphasized and clearer explanation of the potential risks of long-term opioid pain medication use. This decision is the result of a public advisory committee meeting held on May 5, 2025, involving the FDA, Drug Safety and Risk Management Advisory Committee, and Anesthetic and Analgesic Drug Products Advisory Committee. ^[1][2]

These organizations convened to discuss the results of two studies (PMR 3033-1 and PMR 3033-2) that investigated the likelihood of certain risks when using opioid analgesic therapy long-term, in particular, the risk of overdose, addiction, and abuse. These studies have provided new information about the high risk of these outcomes, which the FDA believes should be made clear to healthcare professionals and patients in order to make informed decisions. ^[1]

FDA Commissioner Marty Makary, M.D., M.P.H., has stated that these “long overdue” label changes are necessary to “modernize our approved processes and post-market monitoring”. ^[1]

OxyContin, a brand name oxycodone, was approved by the FDA in 1995, with a label containing misleading information about the safety and risks associated with the drug. This, in part, can be blamed for the sudden rise in opioid addiction and overdoses in the United States. Now, the FDA aims to ensure that these risks are clearly understood by physicians prescribing opioid medications and individuals who use them. ^[1][3]

What's new: Key takeaways from the new FDA labels

The FDA has specified that the following changes are required to opioid medication labels: ^[1]

• Risks of long-term use: A clear explanation and summary of study results with figures relating to risks of long-term use, such as addiction, abuse, and overdose.
• Dose-related risks: Emphasized warnings that the use of higher doses results in greater risks throughout treatment.
• Clarify language: Ensure that any language is changed or removed that could be misinterpreted to support indefinite long-term opioid use.
• Indication for extended-release formulations: Clarify that extended-release or long-acting opioids are only appropriate when other treatments or short-acting opioids are inadequate.
• Withdrawal and discontinuation: Clearly state the dangers of abruptly stopping opioids in those who have developed physical dependence and explain safe tapering.
• Interactions: Information and warnings about drug interactions with opioids, now including gabapentinoids.
• Overdose reversal: Provide information about opioid overdose reversal agents.
• Overdose risks: Add new information about toxic leukoencephalopathy, a serious brain condition that can occur as a result of overdose.
• Update health risks: Add new information about opioid-related esophagus issues.

How will this affect patients and providers?

The FDA provided all relevant companies with information about the required labeling changes. These companies must present their updated labels to the FDA before the end of August 2025, which will then be added to packaged medications once approved. ^[1]

Healthcare providers will then have access to the new information regarding the risks of opioid medications, which may influence their practice in the following ways: ^[2]

• Dosage and type: Opioid medications should be prescribed to manage the individual’s pain when other options are not sufficient and in the lowest effective dose and for the shortest necessary time. Extended-release or long-acting medications should be reserved for severe and persistent pain that is not managed with immediate-release medications.
• Overdose reversal information: Opioid reversal agents, such as naloxone, should be discussed with people when they are prescribed opioids.
• Evaluation and review: For opioid treatment longer than a few days, regular reviews should be conducted, checking the necessity and benefits of continued treatment in order to discontinue treatment when it is no longer required.
• Discontinuation: Prescribing physicians should ensure people are gradually tapered off opioid pain medications to prevent severe withdrawal symptoms, unmanaged pain symptoms, and associated risks.

For patients, these changes will help to increase awareness of the risks associated with the medication and how to ensure it is used safely and appropriately.

Actionable steps for patients and caregivers

People who are prescribed opioid pain medications (or their caregivers) should ensure that they read the new labels once they have been distributed. It is essential that people are aware of the potential risks associated with their medications and have the opportunity to discuss these with their healthcare provider, enabling them to make informed decisions about their treatment.

Opioid pain medications should always be taken exactly as prescribed. People should never take more than is prescribed, change their dosage, or abruptly stop their medication without professional guidance. When discontinuing opioid pain medication, discuss safe tapering with the prescribing physician and follow their instructions about dose reductions.

Medications should be stored in a secure location, out of reach of children and pets. They should not be shared with others, and any spare or unused medications should be returned to a medical professional.

Seeking support for opioid use disorder or withdrawal symptoms

People who require professional support to manage their opioid use or withdrawal symptoms can speak with their primary care physician or prescribing doctor for advice on safe tapering or referral to specialist substance use disorder services. Information about available treatment options and local rehab centers here.

If an opioid overdose is suspected, or if the individual is struggling to breathe, is unresponsive, or is unconscious, call 911 immediately.