FDA Approves Oxycontin For Kids As Young As 11


By Jeanne Whalen

The U.S. Food and Drug Administration said it has approved the use of the painkiller OxyContin in children as young as 11, for severe pain that can’t be adequately treated with other medications.

An FDA spokesman said the agency granted the approval Thursday, after the drug’s manufacturer, Purdue Pharma LP, submitted clinical-trial data on the drug’s safety and efficacy in children. In a posting on its website, the FDA said it asked Purdue to perform the studies in children.

OxyContin is an extended-release version of oxycodone, a powerful opioid painkiller. Widespread use of opioids in recent decades has helped spark what public-health officials call an epidemic of painkiller abuse in the U.S., including soaring rates of overdose deaths.

In a question-and-answer posting on the FDA’s site, the head of the agency’s painkiller division stressed that OxyContin’s new pediatric approval “was not intended to expand or otherwise change the pattern of use of extended-release opioids in pediatric patients,” but to better inform prescribing that was already taking place in children. Doctors are allowed to prescribe medicines any way they see fit, including for uses not approved by the FDA, a practice known as off-label prescribing.

“Prior to this action, doctors had to rely on adult clinical data to shape their decision-making in treating pediatric patients,” Sharon Hertz, director of the FDA’s division of anesthesia, analgesia and addiction products, said in the posting. “This program was intended to fill a knowledge gap and provide experienced health care practitioners with the specific information they need to use OxyContin safely in pediatric patients.”

Purdue’s chief medical officer, Gail Cawkwell, said in an emailed statement: “For the first time, physicians prescribing OxyContin for patients 11 years and older who have already been receiving opioids will be guided by FDA-approved dosing and safety information.”

The FDA’s Dr. Hertz said Purdue’s 2010 reformulation of OxyContin made it more resistant to being crushed or dissolved “to discourage abuse by nasal or intravenous routes.” Doctors and public-health officials say many patients have nonetheless figured out ways to abuse the reformulated drug.

Purdue has said the drug’s reformulation is “expected to reduce abuse,” though abuse “is still possible.”

Dr. Hertz added that OxyContin’s new pediatric approval is similar to its approved use in adults: to manage “pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.” But she said unlike the adult indication, the pediatric indication stipulates that before a child can be prescribed OxyContin, he or she must already be taking and tolerating at least 20 mg of oxycodone a day.

“This way, the doctor knows that their patient tolerates and responds appropriately to opioids,” she said.

Pediatric patients in Purdue’s study were prescribed OxyContin after severe trauma, or “after major spinal surgery or other types of major surgery,” Dr. Hertz said.

She added: “Parents and caregivers should follow all the usual safeguards for storing powerful medications when OxyContin is in their home. Briefly, make sure the medications are stored securely so young children never have direct access and also so that no one else in the household such as older children, siblings, friends, or other visitors have direct access. Also, it is extremely important to safely and properly dispose of unused OxyContin as soon as it is no longer needed.”

An FDA spokesman said as a condition of the new approval, the agency is requiring Purdue to submit data in the coming years characterizing how OxyContin is being used in children aged 17 and younger. He said the FDA will use this data “to examine how many OxyContin prescriptions are being dispensed, to what age groups, and at what doses; what proportion of pediatric patients receiving OxyContin are opioid tolerant; what types of health-care providers are prescribing OxyContin to children, for what indications, and for how long.”

The FDA is also requiring Purdue to submit reports for three years on adverse events involving the drug, including respiratory depression, accidental injury, overdose and misuse, he said.


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