The U.S. Food and Drug Administration (FDA) today announced labeling changes that will be required class-wide for immediate-release (IR) opioid pain medicines.
The announcement is part of a continued effort to provide the proper education to prescribers and patients about the possible dangers that are associated with opioid use.
The changes made by the FDA will require a new boxed warning about the severe hazards of misuse, abuse, addiction, overdose and death. The changes come as part of a number of steps the FDA has laid out in a plan to reevaluate its methods involving opioid medications. The plan revolves around policies that have the common goal of putting a stop to widespread opioid abuse while still allowing patients in need access to the medication.
The FDA will also require changes to opioid product labels that will add safety information about the risks of using the medication. This is part of an effort by the agency to advise patients and prescribers about the importance of balancing the potential risks of opioids and their role in pain management.
Opioid addiction and overdoses have risen to epidemic levels in the past 10 years, which has spurred the FDA into action.