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FDA Approves OxyContin for Pediatric Patients

August 14, 2015
The FDA has approved the use of OxyContin, an extended-release form of oxycodone, for pediatric patients. However, the decision comes with specific guidelines to ensure the patient is safely switched to the medication.

When a child undergoes a major procedure, like a spinal surgery or to correct a birth defect, severe pain becomes a serious concern. Providing around-the-clock, long-term pain management to pediatric patients can be challenging, though, given that so few extended-release medications have been approved for pediatric use.

However, the US Food and Drug Administration recently approved the usage of OxyContin for pediatric patients aged 11 to 16. The FDA’s decision came after it had received sanctioned studies from OxyContin’s manufacturer, Perdue Pharma L.P., that provide evidence of OxyContin’s safety for children and teens.

“To manage pain in pediatric patients, physicians often have to rely on their own experience to interpret and translate adult data into dosing information for pediatric patients,” said Sharon Hertz, MD, director, Division of Anesthesia, Analgesia, and Addiction Products, Office of New Drugs, at the Center for Drug Evaluation and Research (CDER), who wrote about the federal agency’s decision on the FDA website.1

"The new study data and resulting pediatric indication for OxyContin give doctors more specific information on how to safely manage pain in their pediatric patients following these types of surgery or traumas," she noted.

New Indication

OxyContin is recommended for children in severe pain that need constant pain management and don’t respond to alternative therapies. At minimum, patients must already be taking and tolerating 20 milligrams of oxycodone for 5 consecutive days before they can be switched over to an equivalent dose of OxyContin, said Dr. Hertz.

“This way, the doctor knows that their patient tolerates and responds appropriately to opioids and knows the amount of opioid treatment needed to manage the patient's pain. When appropriate, the doctor can then convert their patient over to an OxyContin dose that is tailored to their individual needs," she said.

OxyContin is an extended-release form of oxycodone, useful for patients who require daily, 24-hour pain relief. While immediate-release oxycodone products have to be taken every 4 to 6 hours, OxyContin is designed to be taken every 12 hours, which could have its own benefits, like reduced hospital stays and uninterrupted sleep, Dr. Hertz noted.

However, OxyContin shouldn’t be the first option for pediatric patients in need of pain relief. The new data simply show that children and teens can be safely switched from a 20 mg immediate-release daily opioid regimen to an OxyContin equivalent.

As of now, only 2 extended-release opioids have FDA-approved labeling for younger patients—specifically Duragesic (fentanyl) and now OxyContin. Some immediate-release opioids also provide pediatric information on their labels, but in general, label guidance is sparse for the pediatric setting.

Tailored to Children

“Prior to this action, doctors had to rely on adult clinical data to shape their decision-making in treating pediatric patients. 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,” Dr. Hertz said.

Under the authority provided by the Best Pharmaceuticals for Children Act (BPCA) of 2002, the FDA can request clinical studies from drug manufacturers to investigate a drug’s safety for pediatric patients. The FDA is also requesting postmarketing studies from Purdue Pharma to assess the safe use of OxyContin in children.

Moving forward, new opioid products will be incorporating the pediatric setting, as well, Dr. Hertz said.

“Quite a few of the newer opioid drugs have pediatric studies underway to gather the data that will help prescribers use them safely. I expect that our teams will be working together a lot more in future to make sure that new pediatric pain management options continue to be safe for children in the U.S.”

The warnings and cautions associated with OxyContin for pediatric patients are the same as for adults. The full label can be found here

Here are some precautions Dr. Hertz mentioned:

  • Medical staff must be aware of any medications that are combined with OxyContin, being cautious of anything that might slow down the body’s breakdown of the drug or increase its sedative effects.
  • Taking the patient off OxyContin must be done slowly and cautiously to avoid withdrawal symptoms.
  • Medical staff should inform parents well before the patient is discharged from hospital care and/or taken off OxyContin.
  • Parents must be aware of the risks and behaviors associated with opioid misuse and addiction.
  • OxyContin should be kept in a secure area and then disposed of when no longer needed.
Last updated on: September 14, 2015
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What Every Physician Should Know About Non-pharmaceutical Pediatric Pain Care