Overview

• Opioid manufacturers have 30 days to submit revised labels to the FDA for review.
• Labels must present numerical estimates of addiction, abuse, misuse and fatal and nonfatal overdose based on two postmarketing studies and highlight that higher doses carry increased harm that persists throughout therapy.
• Labels must caution against rapid dose reduction or abrupt discontinuation in dependent patients and include information on overdose reversal agents such as naloxone.
• The agency is requiring a prospective, randomized clinical trial to directly examine long-term opioid benefits and risks.
• The FDA has signaled strengthened postmarket oversight to prevent a repeat of the epidemic by monitoring trial progress and label compliance.