FDA Takes Action to Better Inform Patients on Opioids

Credit: Adobe Stock/Kimberly Boyles

The U.S. Food and Drug Administration (FDA) is making drug companies update the warning labels on all prescription opioids to better reflect the serious risks linked to long-term use — including misuse, addiction and overdose.

“The death of almost 1 million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment,” FDA Commissioner Marty Makary, M.D., M.P.H., said in a statement. “This long-overdue labeling change is only part of what needs to be done — we also need to modernize our approval processes and post-market monitoring so that nothing like this ever happens again.”

The updated labels aim to give both patients and doctors clearer information about how dangerous these medications can be over time.

The FDA reviewed data from two large studies that looked at people using opioids for long periods. The results confirmed that long-term use increases the risk of addiction and overdose, and the agency noted that there isn’t strong evidence that opioids work well when taken for chronic pain over many months or years.

What’s changing on the labels:

• Clearer warnings about risks of misuse, addiction and overdose
• Updated dosing guidance to help avoid accidental harm
• Information about digestive issues and other long-term side effects
• Details on how to safely stop taking opioids
• Guidance on using overdose reversal medications like naloxone
• Warnings about mixing opioids with other drugs

The FDA also announced it will require a new, large clinical trial to better understand the true risks and benefits of taking opioids for chronic pain long term.

The agency admitted past mistakes, including the approval of drugs like OxyContin without long-term data — a decision that played a major role in fueling the opioid epidemic.