WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) announced Thursday that it will require significant changes to the labeling of all opioid pain medications, citing evidence of increased risks associated with long-term use.
The updated labeling will include more direct warnings about the potential for addiction, misuse, and overdose, particularly when opioids are used over extended periods or at higher doses. The changes follow a public advisory committee meeting in May and a review of two large postmarketing studies ordered by the FDA.
The new requirements include:
- A clearer summary of the risks of long-term opioid use, including addiction and overdose.
- Revised language removing references that could be interpreted to support indefinite use.
- Stronger guidance that extended-release opioids should only be used when other pain treatments, including short-acting opioids, are insufficient.
- Warnings against abruptly stopping opioids in physically dependent patients, due to the risk of harm.
- Additional information on interactions with other central nervous system depressants, including gabapentinoids.
- New details about overdose-related brain injury, specifically toxic leukoencephalopathy.
FDA Commissioner Dr. Marty Makary acknowledged the agency’s role in the ongoing opioid crisis and stated that changes to labeling are one step in a broader effort to address systemic failures in drug approval and monitoring processes.
The FDA is also requiring a new clinical trial to further evaluate the long-term use of opioids. Manufacturers have been given 30 days to submit their revised labeling for review.
The updated guidance is intended to provide prescribers and patients with more evidence-based information when considering opioid treatment options.