The U.S. Food and Drug Administration plans to require new labels on all opioid pain medications that emphasizes long-term risks associated with the use of the drugs.
The new rule comes after a public advisory committee meeting in May that reviewed data showing risks for patients who use opioids over long periods. Those risks include misuse, addiction and overdoses.
“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 Dr. Marty Makary said. “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 opioid labeling change reflects data from two FDA-required observational studies.
“I know firsthand how devastating addiction is – not just for individuals, but for entire families and communities,” HHS Secretary Robert F. Kennedy Jr. said. “Today’s FDA action is a long-overdue step toward restoring honesty, accountability, and transparency to a system that betrayed the American people.”
The labeling changes include:
Clearer Risk Information: A summary of study results showing the estimated risks of addiction, misuse, and overdose during long-term use.
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Author: Ray Hilbrich
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