FDA

FDA tightens opioid labeling to spotlight long-term risks

August 4, 2025

FDA is mandating class-wide safety labeling changes for opioid pain medications to better reflect the risks associated with long-term use. This decision follows two large observational studies that showed significant rates of addiction (1% to 6%), abuse (9%), and misuse (22%) among patients on extended opioid therapy. Additionally, the risk of opioid overdose-related death over five years ranged from 1.5% to 4%, with 17% of first overdoses proving fatal.

Key labeling updates include:

• Removal of the phrase “extended treatment period” to avoid implying indefinite safety or efficacy.
• Stronger warnings about dose-dependent risks and persistent harm over time.
• Inclusion of quantitative risk estimates from recent studies.
• Clarification that extended-release/long-acting opioids should be reserved for cases where other treatments fail.
• Emphasis on avoiding abrupt discontinuation in physically dependent patients.
• Enhanced warnings about central nervous system depressant interactions and new information on overdose-related toxic leukoencephalopathy.

These labeling updates are intended to guide more informed prescribing and enhance patient counseling for chronic pain management. To initiate the process, FDA has issued formal notification letters to all relevant opioid manufacturers, detailing the required changes. Companies now have 30 days to submit revised prescribing information for FDA review and approval.

Source:

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