FDA Approval of Extended-Release Oxycodone for Children with Severe Pain: A Step Forward.

, number 5 , May 2016 :e 20160205 In a highly controversial decision, the Food and Drug Administration (FDA) approved, in August 2015, extended-release oxycodone for use by children between 11 and 16 years old with “pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.”1 For the first time, doctors are provided specific dosing guidance for pediatric patients who must already be responding to and tolerating a minimum opioid dose equal to at least 20 mg oxycodone per day before they can be prescribed an equivalent dose of extended-release oxycodone.1 With this decision, on-label prescribing of extended-release oxycodone to children has become a possibility. Previously, it was only prescribed off-label in the pediatric setting, even though the practice was common and generally accepted. Although the potential risks of increased opioid addiction and abuse among youth are a legitimate concern, they are outweighed by the tangible benefits of the new pediatric safety and dosing instructions. The approval provides health care practitioners with evidence-based information to use extended-release oxycodone more safely in pediatric patients.