The Food and Drug Administration will soon require drugmakers to place stronger warning labels on opioids to convey the risks associated with these medications.
The labels will include clearer risk information about addiction, misuse, and overdose; stronger warnings regarding higher doses and their long-term risks; clarified use limits to prevent misinterpretation of long-term use; treatment guidance recommending long-acting opioids only if shorter options are inadequate; advice against sudden discontinuation for physically dependent patients; and information on overdose reversal agents.
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These changes to label rules come as the FDA claims that OxyContin was approved illegally and without proper study supporting its long-term use. The maker of OxyContin, Purdue Pharma, reached a $7.4 billion settlement for its "manufacturing and distribution of opioids that fueled a nationwide addiction epidemic."
“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, M.D., M.P.H. “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 FDA said drugmakers have 30 days to submit labeling updates for review.
