WASHINGTON, Aug. 14 (Stephen Feller) — The Food and Drug Administration approved OxyContin for use with children in specific health situations to manage chronic and extreme pain, according to a press release from the agency.
The approval comes after FDA requested the manufacturer of the opioid painkiller, Purdue Pharma, perform studies on safety and guidance for use with pediatric patients who already have been treated with a similar drug.
“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 Dr. Sharon Hertz, director of the Division of Anesthesia, Analgesia, and Addiction Products at the FDA, in a press release.
OxyContin is a version of oxycodone, a highly addictive opioid that acts in the brain similarly to heroin, packaged as a time-release pill to manage chronic and extreme pain. The pill was reformulated five years ago to be more difficult to crush or dissolve in order to combat its highly addictive nature.
Hertz said the agency requested the company do studies specifically with children because of the need for stronger drugs to treat pain in children — following procedures to correct extensive trauma, after major spinal or other surgery.
The agency is requiring that pediatric patients be between 11 and 16 years old and already have been treated with an opioid equivalent to 20 mg per day of oxycodone in order to be sure that their bodies can handle OxyContin.
“I must stress that this program was not intended to expand or otherwise change the pattern of use of extended-release opioids in pediatric patients,” Hertz said. “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.”