FDA Addresses Opioid Medication Safety With Additional Label Changes
The FDA also recommended a scheduling action for 7-hydroxymitragynine (7-OH), with data showing the drug binds to opioid receptors.
The FDA will now require additional safety label changes to all opioid medications, including the risks associated with long-term use. In May 2025, a public advisory committee reviewed data on opioids, which included misuse, addiction, and fatal and nonfatal overdoses, for patients using opioids over a long period.1
The FDA also calls for a scheduling action for 7-hydroxymitragynine (7-OH), with data showing the drug binds to opioid receptors. | Image Credit: Tada Images - stock.adobe.com
“The death of almost one million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment,” Marty Makary, MD, MPH, commissioner of the FDA, said in a news release.1 “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 changes include a clearer summary of study results that detail the risks of addiction, misuse, and overdose associated with long-term use, as well as stronger warnings that show the greater risks of higher doses and prolonged use. Additionally, the FDA calls for removing language that supports the long-term use of opioids, emphasizes that long-acting or extended-release opioids should be considered when other treatment is inadequate, and reminds patients of the risk of suddenly stopping opioids, especially for those who are physically dependent.1
Furthermore, the FDA will include changes on overdose reversal agents, drug interactions, which now include gabapentinoids, new information on toxic leukoencephalopathy and issues related to the esophagus. The FDA sent letters to all relevant applicants, and companies will have 30 days to submit the updates to the FDA for review.1
Earlier, the FDA also recommended a scheduling action to control 7-hydroxymitragynine (7-OH) products under the Controlled Substance Act. According to a news release, the FDA is targeting “7-OH, a concentrated byproduct of the kratom plant; it is not focused on natural kratom leaf products. 7-OH is increasingly recognized as having potential for abuse because of its ability to bind to opioid receptors.”1
This recommendation comes from an analysis of medical and scientific evidence by the FDA, emphasizing the agency’s initiative to address the growing availability and use of 7-OH opioid products, as there are no FDA-approved 7-OH drugs.1
In the report, the authors state, “These data sources indicate that 7-OH is a potent opioid that poses an emerging public health threat, especially when considering the increasing availability of enhanced or concentrated 7-OH products in the marketplace.” They added that 7-OH demonstrates greater mu-opioid receptor potency than kratom’s mitragynine and classic opioids, including morphine. The results of the analysis showed that the drug has high binding affinity to mu-opioid receptors and produced respiratory depression, physical dependence, and withdrawal symptoms that were similar to classical opioids, including morphine, fentanyl, oxycodone, and hydrocodone.3
The authors concluded that the data establishes 7-OH as a dangerous substance. The authors stated, “Current regulatory gaps have enabled widespread availability of these products despite their opioid-like properties and necessitate immediate policy intervention to address this emerging threat to American public health.”3
READ MORE: Pain Management Resource Center
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REFERENCES
1. FDA requires major changes to opioid pain medication labeling to emphasize risks. News release. FDA. July 31, 2025. Accessed August 4, 2025. https://www.fda.gov/news-events/press-announcements/fda-requires-major-changes-opioid-pain-medication-labeling-emphasize-risks
2. FDA takes steps to restrict 7-oh opioid products threatening American consumers. News release. FDA. July 29, 2025. Accessed August 4, 2025. https://www.fda.gov/news-events/press-announcements/fda-takes-steps-restrict-7-oh-opioid-products-threatening-american-consumers
3. FDA. 7-hydroxymitragynine (7-OH): an assessment of the scientific data and toxicological concerns around an emerging opioid threat. July 2025. Accessed August 4, 2025. https://www.fda.gov/media/187899/download?attachment
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