Washington, D.C. Citing evidence of heightened dangers linked with long-term use, the U.S. Food and Drug Administration (FDA) said Thursday that it will mandate significant revisions to the labeling of all opioid pain drugs.
More explicit warnings regarding the risk of addiction, abuse, and overdose—especially when opioids are used for longer periods of time or at larger dosages—will be included in the revised labeling. The modifications come after a public advisory committee meeting in May and an FDA-ordered evaluation of two sizable postmarketing studies.
Among the new prerequisites are:
- 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.
Changes to labeling are one step in a larger attempt to address systemic flaws in drug approval and monitoring systems, FDA Commissioner Dr. Marty Makary said, acknowledging the agency’s role in the ongoing opioid crisis.
A new clinical study is also being mandated by the FDA to assess the long-term effects of opioid use. Manufacturers have 30 days to send in their updated labeling for evaluation.
The goal of the revised guidance is to give patients and prescribers additional evidence-based information when they are weighing their options for opioid treatment.
