6 days ago
FDA Calls for Better Opioid Safety Labeling
The FDA is requiring manufacturers of opioid pain medications to update safety labels to better emphasize risks linked to their long-term use, the agency announced in a new Drug Safety Communication.
The changes are based on observations from a May meeting between the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee, which met to discuss two postmarketing requirement studies that assessed risk for abuse, addiction, and overdose in long-term use of opioid analgesics.
One of the observational studies showed that over 12 months of use, 1%-6% of the more than 2000 total participants met criteria for opioid addiction, 9% met criteria for prescription opioid abuse, and 22% met criteria for prescription opioid misuse.
In the second study, 5-year cumulative incidence estimates for opioid overdose-related death ranged from 1.5%-4.0%. In addition, 17% of first opioid overdoses over the entire 5-11 year study period were fatal.
The new safety-labeling requirements are a result of these findings, committee and public comments from the meeting, and recognition that there is currently an 'absence of adequate and well-controlled studies on long-term opioid effectiveness,' the FDA noted in a press release.
'The death of almost 1 million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment,' FDA commissioner Marty Makary, MD, said in the release.
30-Day Warning
The FDA has also called for a new prospective, randomized controlled trial to be conducted that will focus primarily on assessing risks and benefits of opioids used over the long term.
For now, the updated labeling should include a better explanation of risks, stronger warnings about higher doses, clarification about use limits, an emphasis that long-acting or extended-release opioids should only be used if shorter-acting opioids or other medications have proven inadequate, and a reminder about serious harm that can come if a patient who becomes physically dependent does not stop opioid use.
Additionally, the revised labels should provide information on possible opioid-related problems with the esophagus; on opioid overdose reversal agents; on toxic leukoencephalopathy, which can occur after overdose; and on negative drug-drug interactions, including gabapentinoids.
'This long-overdue labeling change is only part of what needs to be done — we also need to modernize our approval processes and postmarket monitoring,' Makary said. The release noted that OxyContin's drug application was first approved without supportive long-term use data.
The FDA added that manufacturers have 30 days to submit the newly required labeling updates for review.
