Overview

• The FDA’s order is now in effect, requiring all opioid pain medications to carry clearer warnings about addiction, misuse and overdose over extended use.
• Updated labels must specify dosing limits, stronger warnings at higher doses and guidance that long-acting formulations be reserved for cases where short-acting treatments are insufficient.
• New safety information must address discontinuation risks in physically dependent patients, esophageal complications, toxic leukoencephalopathy and interactions with CNS depressants like gabapentinoids.
• Companies that fail to submit the revised labeling within 30 days will face possible enforcement actions by the agency.
• In addition to the labeling overhaul, the FDA has called for a new prospective, randomized controlled trial to fill long-term effectiveness and harm data gaps for opioid therapy.