August 4, 2025
The Food & Drug Administration (FDA) announced on Thursday that opioid medications will be required to have their labeling updated to highlight the risk of long-term use.
The agency is requiring opioid manufacturers to add to the prescribing information that higher doses are associated with increased risk of serious harm, and that serious damage could persist over the course of therapy, among other changes.
“The death of almost one million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment,” FDA Commissioner Marty Makary, MD, MPH, said in a press release. “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.”
