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

Dear Editor,We read with interest the article by Yang and colleagues [1] entitled “FDA Approval of Extended-Release Oxycodone for Children with Severe Pain”, published in Pediatrics . The authors comment on the approval of extended-release (ER) oxycodone for use by children between 11 and 16 years old when alternative treatment options are inadequate. Yang et al. state that for the first time doctors are provided specific dosing guidance for pediatric patients. With this decision, there now is effectively on-label prescribing of ER oxycodone to children [1].Bazzano and colleagues [2] examined the frequency of off-label prescribing to children at US outpatient visits and determined how drug class, patient age, and physician specialty have related to off-label prescribing. The authors found that 62% of outpatient pediatric visits included off-label prescribing. Approximately 96% of cardiovascular-renal, 86% of pain, 80% of gastrointestinal, and 67% of pulmonary, and 67% of dermatologic medication prescriptions were off-label. Bazzano et al. concluded that despite recent studies and labeling changes of pediatric medications, the majority of pediatric outpatient visits involve off-label prescribing across all medication categories. Further, off-label prescribing is more frequent for younger children and those receiving care from specialist pediatricians [2].The Policy Statement of the American Academy …