FDA Will Review Opioid Analgesic Use and REMS Programs for Pediatric Pain Patients Save

Amidst a stringent regulatory environment, and with the rising use and abuse of narcotics and increasing regulation limiting narcotic analgesic use, the FDA approved (August 2015) the use of extended-release oxycodone in children (11 to 16 years old) with severe, "around-the-clock" pain who have had an insufficient response to shorter acting opioids.

Prior to this approval, such therapy could only be prescribed off-label in pediatric patients. The approval provides practitioners with evidence-based information to use extended-release oxycodone more safely in pediatric patients. This approval has not been without controversy.  

Next month (May 3-4, 2016), the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee will meet to discuss the results from assessments of the extended- release and long-acting Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS).  This will be followed by a September 15-16, 2016 joint meeting of the  Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Pediatric Advisory Committee to establish plans for the safe and effective use of opioid analgesics in pediatric patients.