FDA orders opioid label changes to highlight long-term risks

Editor's Note

The US Food and Drug Administration (FDA) is requiring safety labeling changes for all opioid pain medications to better emphasize and explain the risks associated with long-term use, according to a July 31 announcement.

These changes follow a May advisory committee meeting where the agency reviewed data on the serious risks of prolonged opioid use, including misuse, addiction, and both fatal and non-fatal overdoses. In the announcement, FDA Commissioner Marty Makary calls the death of almost one million Americans during the opioid epidemic “one of the cardinal failures of the public health establishment.”

The announcement says the decision is based on data from two large FDA-required observational studies. The agency also reviewed medical research, public comments, and noted the lack of adequate and well-controlled studies evaluating long-term opioid effectiveness. These findings led to a decision to require labeling updates to help healthcare professionals and patients make treatment decisions based on the latest evidence.

The required changes include a summary of study results showing the estimated risks of addiction, misuse, and overdose during long-term use. Labels must include stronger warnings that higher doses pose greater risks, and that those risks persist over time. Language that could be misinterpreted as supporting indefinite opioid use will be removed. Labels will also reinforce that long-acting or extended-release opioids should only be considered when other options, including shorter-acting opioids, are inadequate.

Additional label changes include a reminder not to abruptly discontinue opioids in physically dependent patients, information on medications that can reverse opioid overdose, and enhanced warnings about combining opioids with other nervous system depressants, now including gabapentinoids. The FDA also added new information on toxic leukoencephalopathy, a serious brain condition that may occur after an overdose, and updates regarding opioid-related esophageal problems.

Refer to the full announcement for additional details, including requirements for drug manufacturers and details on a related clinical trial.