(Reuters)—The U.S. Food and Drug Administration announced on Tuesday new required class-wide safety labeling changes for immediate-release opioid pain medications.
Among the changes, the FDA now requires these pain medications to carry a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death.
The FDA also requires several additional safety labeling changes across all prescription opioid products to include additional information on the risk of these medications.
These steps are part of the FDA’s “overall effort to help inform prescribers about the importance of balancing the serious risks of opioids with their role in managing pain,” the FDA said in a news release.
“Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids,” FDA commissioner Dr. Robert Califf said in the release.
“Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic,” he added.
The U.S. Centers for Disease Control and Prevention (CDC) last week released voluntary guidelines that instruct primary care doctors to sharply deter the use of opioids for chronic pain.
Overprescribing opioids, largely for chronic pain, is a key driver of America’s drug-overdose epidemic, the CDC estimates.
