Oxycontin Approved for Pediatric Patients

Oxycontin Approved for Pediatric Patients
Oxycontin Approved for Pediatric Patients

The Food and Drug Administration (FDA) announced that it has approved labeling updates for Oxycontin (oxycodone HCI; Purdue Pharma) extended-release tablets to expand the age range to include patients aged ≥11 for pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The approval is based on a study of 155 pediatric patients previously receiving and tolerating opioids for at least five consecutive days with a minimum of 20mg per day of oxycodone or its equivalent on the two days immediately preceding dosing with Oxycontin. The pediatric patients were initiated on a total daily dose ranging from 20–100mg based on prior opioid dose. The most frequent adverse events observed in pediatric patients were vomiting, nausea, headache, pyrexia, and constipation.

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The FDA is requiring postmarketing studies on the serious risks of respiratory depression, accidental injury, overdose, misuse, accidental exposure, and medication errors associated with the use of Oxycontin in opioid-tolerant pediatric patients aged 11–17, and to assess the serious risks of respiratory depression, accidental injury, overdose, misuse, accidental exposure, and medication errors associated with the use of the product in children who are either younger than the approved age range or who do not meet the labeled criteria for opioid tolerance. Reports of all postmarket adverse events occurring in children aged ≤17 and younger related to respiratory depression, accidental injury, overdose, misuse, accidental exposure, and all medication errors, regardless of outcome, are also mandated.

Oxycontin, an opioid agonist, is now approved for use in pediatric patients ≥11 years receiving and tolerating opioids for at least five consecutive days with a minimum of 20mg per day of oxycodone or its equivalent for at least two days immediately preceding dosing with Oxycontin. It is not appropriate for use in pediatric patients requiring <20mg total daily dose. It is already approved for pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in adults.

For more information call (888) 463-6332 or visit FDA.gov.