Originally published by our sister publication Pain Medicine News
By Kenny Walter
The FDA announced major changes to its opioid pain medication labeling regulations that better emphasize and explain the risks of using the medications over long periods.
The July 31 announcement came after a public advisory committee meeting in May where experts reviewed the data showing the risks for misuse, addiction, and both fatal and nonfatal overdoses for patients treated with opioids for longer periods.
The labeling changes include clearer risk information given as a summary of study results on the estimated risks for addiction, misuse and overdose, dosing warnings, clarified use limits that remove language that could be misinterpreted, treatment guidance that reinforces long-acting or extended-release use of opioids when other treatments are not adequate, and safe discontinuation guidance.
The changes also call for additional information on overdose reversal agents and drug interactions, as well as information on the risk for overdose and updates about opioid-related digestive health problems.
“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, MPH, in a statement. “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 has required additional prospective randomized controlled trials that directly address the benefits and risks of long-term use.
The impetus behind the changes comes after the New Drug Application for OxyContin (oxycodone, Purdue) was approved without robust data supporting its long-term use in many patient populations. However, the updated labeling changes reflect new data from a pair of observational studies showing the serious side effects caused by long-term use.
The FDA sent letters to opioid manufacturers mandating they have 30 days to submit their new labeling updates for FDA review.
