FDA approves OxyContin® for use in children as young as 11

The FDA has approved OxyContin®, an extended-release version of the opioid medicine oxycodone, for use in children 11 to 16 years old. The decision was based on results of studies evaluating the use of the drug in children. The decision is not intended to increase the use of opioids in pediatric patients, but is instead intended to provide physicians with information regarding pediatric dosing, rather than requiring them to base decisions on their own experience and adult clinical data.


Oxycodone is an opioid pain management medicine used to treat severe and sometimes chronic pain in adults. Immediate-release oxycodone products are generally taken every four to six hours, while extended-release oxycodone products, like OxyContin, are taken every 12 hours, often making it easier for patients to sleep through the night or engage in physical therapy regimens. Until recently, OxyContin and other pain management product labels did not include information about their safety and effectiveness in pediatric patients.

Clinical studies

The FDA used its authority pursuant to the Best Pharmaceuticals for Children Act (BCPA) of 2002 (P.L. 107-109) to issue a Pediatric Written Request to Purdue Pharma LP to ask it to conduct studies evaluating the safety of the drug in children. The BCPA provides an incentive for companies to participate in such studies in the form of a six-month extension of exclusivity for all uses of the drug at issue. The studies considered the fact that pediatric patients typically do not have the types of chronic pain conditions that adults have and that many potential patients might require pain management for a period of weeks after extensive trauma or certain major surgeries. The studies supported the use of OxyContin in children ages 11 to 16 years old.


The FDA approved the use of the drug in children ages 11 to 16, making it the second extended-release pain relief product approved for pediatric use, after the narcotic Duragesic® (fentanyl). Unlike adult patients, however, pediatric patients must already respond to and tolerate an opioid dose of at least 20 milligrams of oxycodone before being prescribed OxyContin. Sharon Hertz, M.D., Director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research Division of Anesthesia, Analgesia, and Addiction Products, emphasized that the approval was “not intended to expand or otherwise change the patter of use of extended-release opioids in pediatric patients.” Rather, it “was intended to fill a knowledge gap” and provide practitioners with the information they need to make safe, informed decisions. Warnings for children remain the same as those for adults.