FDA approves OxyContin for some pediatric patients


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

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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Under the Best Pharmaceuticals for Children Act (BPCA) of 2002, FDA requested a Pediatric Written Request to ask the makers of OxyContin to study oxycodone and OxyContin in pediatric patients. One of the studies evaluated the safety of OxyContin and how the drug moves through the body in pediatric patients likely to receive OxyContin from their doctors. “Pediatric patients don’t usually have the same kind of chronic pain conditions as adults, so patients in the study were prescribed OxyContin in situations where they were expected to require pain management with an opioid for many weeks-for example, after extensive trauma, or after major spinal surgery or other types of major surgery to correct of birth defects,” Hertz wrote.

The studies supported the addition of a pediatric indication to the OxyContin label for patients aged 11 to 16 years, and provided the much-needed data to healthcare providers. “The new study data and resulting pediatric indication for OxyContin give doctors more specific information on how to safely manage pain in their pediatric patients following these types of surgery or traumas,” Hertz wrote.

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And OxyContin will not just be prescribed for children in hospital settings. “If there's a need for ongoing treatment with an opioid after discharge from the hospital, pediatric patients 11 to 16 years old can be prescribed OxyContin and their parents and caregivers can get the medication at a pharmacy and administer the medicine as directed at home,” Hertz wrote.

In pediatric patients who require opioid treatment to manage pain, extended-release opioids may be a useful alternative because they are taken only once or twice per day rather than every 4 to 6 hours, according to Hertz.

FDA posted the full label for pediatric Oxycontin products on its website.

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