OxyContin Approved for Pediatric Use

The FDA has expanded the use of the powerful painkiller oxycodone (OxyContin) for children as young as 11.

The extended-release opioid is newly indicated to treat chronic pain in patients aged 11 to 16 years, after studies from drug maker Purdue Pharma proved it safe for use in this pediatric population.

Sharon Hertz, MD, director of the FDA’s division of anesthesia, analgesia, and addiction products, said the agency asked Purdue to study OxyContin’s effect in pediatric patients after noticing a lack of information on the painkiller’s safety and effectiveness in children.

While labeling and dosage instructions for painkillers are clear for adult patients, very few provide specific information for children. For those pediatric patients that require chronic pain management, physicians have to infer appropriate dosage amounts on their own, based on past experience.

“We are always concerned about the safety of our children, particularly when they are ill and require medications, and when they are in pain,” Dr. Hertz said in a recent Center for Drug Evaluation and Research conversation. “OxyContin is not intended to be the first opioid drug used in pediatric patients, but the data show that changing from another opioid drug to OxyContin is safe if done properly.”

Nevertheless, strict limitations have been placed on OxyContin for pediatric use. For instance, Dr. Hertz said children must have already been treated with an opioid prior to receiving OxyContin, and they must also tolerate a minimum dose of at least 20 mg of oxycodone before being prescribed an equivalent dose of OxyContin.

Parents of pediatric patients taking OxyContin are reminded to always store it securely to prohibit direct access, and unused OxyContin should be properly disposed of after it is no longer needed.