The U.S. Food and Drug Administration is taking significant steps in the ongoing fight against the Opioid Crisis.
On Thursday, the federal agency announced it will require safety labeling changes for all opioid pain medications to provide clearer information about the risks of long-term use.
These changes follow a public advisory meeting in May, where officials reviewed data highlighting serious risks for patients using opioids over extended periods, including misuse, addiction, and both fatal and non-fatal overdoses.
“The death of almost one million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment,” said FDA Commissioner Marty Makary, M.D., M.P.H. “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.”
Additionally, the updated labels will remove language that could be interpreted as supporting indefinite use and will include new information about dose-related risks, withdrawal, treatment guidance, as well as rare but serious risks like brain injury after an overdose.
For more information, visit the FDA’s Drug Safety Communication.