The FDA has announced new requirements for safety labeling on all opioid pain medications that place renewed emphasis on the risks associated with their long-term use.
According to a July 31 news release, the changes follow a public advisory committee meeting in May that reviewed data surrounding misuse, addiction, and both fatal and nonfatal overdoses for patients who use opioids long term.
“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, MD, in the 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.”
The updated labeling is based on data from two large FDA-required observational studies. The studies revealed new data on how long-term opioid use can lead to serious side effects. The FDA decided to require safety labeling changes after reviewing the results of these studies, as well as public comments and medical research, and recognizing the absence of adequate and well-controlled studies on the long-term effectiveness of opioids.
The labeling changes include:
• Clearer risk information
• Dosing warnings
• Clarified use limits
• Treatment guidance
• Safe discontinuation of use
• Overdose reversal agents
• Drug interactions
• More information on overdose risks
• More information about digestive health
A full description of the changes can be found on the FDA’s website.
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