FDA approves OxyContin for some pediatric patients

FDA recently granted special approval of pediatric use of OxyContin in patients aged 11 to 16 years old, under specific conditions.

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“We requested the manufacturer [Purdue Pharma- of the pain management drug, OxyContin,  perform studies evaluating safety and other important information about oxycodone and OxyContin when used in pediatric patients. These studies supported a new pediatric indication for OxyContin in patients 11 to 16 years old, and provided prescribers with helpful information about the use of OxyContin in pediatric patients,” Sharon Hertz, MD, director of the Division of Anesthesia, Analgesia, and Addiction Products at FDA’s Office of New Drugs, Center for Drug Evaluation and Research, wrote in CDER Conversations.

Duragesic (fentanyl) and OxyContin are now the only extended-release opioid products with FDA-approved labeling regarding pediatric use.

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Similar to adults, OxyContin is approved for use in pediatric patients to manage pain that is “severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate,” Hertz wrote. “The major difference is that all pediatric patients that are considered for pain management with OxyContin should already have been treated with an opioid pain medicine. This way, their health care providers know that these pediatric patients can be treated safely with OxyContin,” she added.

Because there is not much opioid use in children, FDA had to carefully identify how the drugs were being used, along with information that would be useful to prescribers, before approving Oxycontin for pediatric use.

 

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