FDA to change opioid labeling rules to emphasize long-term risks

(The Center Square) – The U.S. Food and Drug Administration plans to require new labels on all opioid pain medications that emphasizes long-term risks associated with the use of the drugs.

The new rule comes after a public advisory committee meeting in May that reviewed data showing risks for patients who use opioids over long periods. Those risks include misuse, addiction and overdoses.

"The death of almost one million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment," FDA Commissioner Dr. Marty Makary said. "This long-overdue labeling change is only part of what needs to be done – we also need to modernize our approval processes and post-market monitoring so that nothing like this ever happens again."

The opioid labeling change reflects data from two FDA-required observational studies.

"I know firsthand how devastating addiction is – not just for individuals, but for entire families and communities," HHS Secretary Robert F. Kennedy Jr. said. "Today's FDA action is a long-overdue step toward restoring honesty, accountability, and transparency to a system that betrayed the American people."

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The labeling changes include:

• 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 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.
• 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.

Companies have 30 days to submit their labeling updates to the FDA for review.

Dr. Bobby Mukkamala, president of American Medical Association, said the FDA was on the right track.

"The FDA's requirement on opioid labels appropriately focuses on physicians making individualized, informed decisions about opioid prescribing while supporting informed decision-making for patients," he said in a statement. "The AMA agrees that decisions whether to begin opioid therapy must be made on whether the benefits outweigh the known risks."