US FDA issues tougher opioids warning labeling

In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the US Food and Drug Administration yesterday announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications.

Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. These actions are among a number of steps the agency recently outlined in a plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.

The FDA is also requiring several additional safety labeling changes across all prescription opioid products to include additional information on the risk of these medications. This is part of the agency’s overall effort to help inform prescribers about the importance of balancing the serious risks of opioids with their role in managing pain.