FDA Emphasizes Opioid Risks in New Labeling Requirement

The FDA is requiring new labeling for opioids to emphasize long-term risks, including misuse, addiction, and overdose.1

“The death of almost one million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment,” Marty Makary, MD, MPH, FDA Commissioner, said in a statement.1 “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 new changes come after a May 2025 public advisory committee meeting reviewed data showing demonstrating risks, including misuse, addiction, and both fatal and non-fatal overdoses, for patients who use opioids over long periods, from 2 large postmarketing requirement (PMR) observational studies, 3033-1 and 3033-2. The meeting also reviewed public comments, other medical research, and recognized the absence of adequate and well-controlled studies on long-term opioid effectiveness.2

The new labeling will require clearer risk information outlining data seen in long-term use studies, including overdoses and digestive health; dosing warnings; clarified use limits that emphasize the risks of long-term use; up-to-date treatment guidance; guidance on safe discontinuation; information on overdose reversal agents; and information on drug interactions. In the announcement, the FDA also acknowledged how OxyContin was historically approved without long-term data of its use for pain before the full breadth of its risks were widely known. Additionally, the FDA has required another prospective, randomized, controlled clinical trial to directly examine the benefits and risks of long-term opioid use.1

The FDA has sent letters to relevant sponsors outlining the required changes, after which they will have 30 days to submit their labeling updates to the FDA for review.

REFERENCES

1. FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks. News release. FDA. July 31, 2025. https://www.fda.gov/news-events/press-announcements/fda-requires-major-changes-opioid-pain-medication-labeling-emphasize-risks

2. UPDATED MEETING DATE AND PUBLIC PARTICIPATION INFORMATION: May 5, 2025 Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement. FDA. May 5, 2-25. https://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-meeting-date-and-public-participation-information-may-5-2025-joint-meeting-drug-safety-and