FDA Approves OxyContin for Certain Children

The US Food and Drug Administration (FDA) has approved the prescription of OxyContin, an extended-release opioid, for particular pediatric patients.

The US Food and Drug Administration (FDA) has approved the prescription of OxyContin, an extended-release opioid, for particular pediatric patients.

OxyContin is used to manage severe pain in adult patients with conditions such as chronic pain, osteoarthritis, and cancer-related pain. The FDA has approved the drug for children ages 11 to 16 in similar situations who are experiencing pain that requires daily, around-the-clock opioid management for which alternative treatment options are inadequate.

“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,” Sharon Hertz, MD, director of the Division of Anesthesia, Analgesia, and Addiction Products, Office of New Drugs, and Center for Drug Evaluation and Research at the FDA, said in a statement.

Before authorizing the approval, the FDA requested that the makers of OxyContin conduct studies to show the safety of the drug in pediatric patients. The participants were expected to need opioids for pain management due to trauma, major spinal surgery, etc. The studies analyzed how OxyContin moved throughout the body specifically in younger patients. The findings supported the use in patients ages 11 to 16.

Since OxyContin has been known to be misused and abused, regardless of the tamper-resistant formula change in 2010, some may remain skeptical about allowing the prescription for children.

“The major difference is that all pediatric patients that are considered for pain management with OxyContin should already have been treated with an opioid pain medicine,” Hertz continued. “This way, their health care providers know that these pediatric patients can be treated safely with OxyContin.”

Hertz explained that before pediatric patients are prescribed OxyContin, they must be able to tolerate at least 20 mg of oxycodone per day — a requirement not needed for adult patients. Several other newer opioid drugs are currently under observation to study usage in pediatrics as well.

“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 US,” Hertz concluded.