The risk labels on opioid pain medications are being revised, according to the U.S. Food and Drug Administration (FDA). The updates stress the risks of extended use. The goal of this action is to reduce opioid addiction, abuse, and overdose, and to aid clinical decision making.
Additionally, the FDA “has required an additional prospective, randomized, controlled clinical trial to directly examine the benefits and risks of long-term opioid use.”
Changes to opioid pain medication labels include:
Study evidence highlighting the risks of prolonged use.
Larger emphasis on dosage risks.
Revised language that doesn’t support long-term use.
Statement that “long-acting or extended-release opioids should only be considered when other treatments, including shorter-acting opioids, are inadequate.”
Caution to not abruptly stop opioids in addiction risk patients.
Instructions on how to stop an overdose.
Information about how opioids interact with other drugs.
Overdose risks and effects.
Impact of opioids on the esophagus.
Affected applicants have been notified by the FDA via letter about the revisions and “will have 30 days to submit their labeling updates to the FDA for review.”
