FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

FDA Approves OxyContin for Kids Age 11 and Older

Aug. 24, 2015

New labeling states the drug is for use in kids 11 years and older who have been receiving and tolerating opioids for at least five consecutive days and a minimum of 20 mg per day of oxycodone or its equivalent for at least two days immediately preceding dosing with OxyContin. The label also warns users to discontinue all other round-the-clock opioids when OxyContin therapy begins.

Under the Best Pharmaceuticals for Children Act of 2002, the FDA issued a request to study OxyContin (oxycodone) in children who required extended pain management due to trauma, major surgery or procedures to correct birth defects. That study showed that children can safely switch from another opioid to OxyContin, according to a Q&A piece posted to the FDA’s website.

As part of postmarketing requirements, Purdue must assess the risks of respiratory depression, accidental injury, overdose, misuse, accidental exposure and medication errors associated with OxyContin use in children and submit a final report to the FDA by April 2019.

The drugmaker must also collect data on the total number of pediatric prescriptions dispensed across the nation, the total number of unique patients and the duration of therapy. A report on those findings is due on December 2018. — John Bechtel