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Research Letter
September 09, 2016

Effect of US Food and Drug Administration–Approved Pediatric Labeling on Dispensing of Extended Release Oxycodone in the Outpatient Retail Setting

Author Affiliations
  • 1Office of Public Health Strategy and Analysis, Office of Commissioner, US Food and Drug Administration, Silver Spring, Maryland
  • 2Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland

Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA Pediatr. Published online September 9, 2016. doi:10.1001/jamapediatrics.2016.3197

For years, extended-release (ER) oxycodone has been prescribed to children for management of pain.1,2 In August 2015, based on studies conducted under the Best Pharmaceuticals for Children Act that are designed to better inform pediatric prescribing, the US Food and Drug Administration approved the use of OxyContin (Purdue Pharma) for management of pain requiring treatment with an ER/long-acting opioid in children 11 years and older who are already tolerating a daily opioid dose equivalent to at least 20 mg of oxycodone, as described in the labeling.3 The new labeling was not intended to expand pediatric use of ER opioids, but rather to help clinicians use OxyContin safely in pediatric patients.

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