WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration is requiring safety labeling changes to all opioid pain medications to better emphasize and explain the risks associated with their long-term use. These changes follow a public advisory committee meeting in May that reviewed data showing serious risks such as misuse, addiction, and both fatal and non-fatal overdoses for patients who use opioids over long periods.
'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. '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 labeling change reflects robust data from two large FDA-required observational studies, called postmarketing requirements (PMR) 3033-1 and 3033-2, which recently provided new data on how long-term opioid use can lead to serious side effects. FDA said that after reviewing those results, public comments, medical research and recognizing the absence of adequate and well-controlled studies on long-term opioid effectiveness, it decided to require safety labeling changes to help health care professionals and patients make treatment decisions rooted in the latest evidence.
FDA noted that the new drug application for OxyContin was initially approved without study data supporting its long term use to treat pain in many patient populations for which it has been prescribed.
'I know firsthand how devastating addiction is-not just for individuals, but for entire families and communities,' said HHS Secretary Robert F. Kennedy, Jr. '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 will include Clearer Risk Information, Dosing Warnings, Clarified Use Limits, Safe Discontinuation, Overdose Reversal Agents, Drug Interactions, Digestive Health and More Risks with Overdose.
Copyright(c) 2025 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
© 2025 AFX News
