Aug. 13, 2015 -- The FDA has approved the use of OxyContin in children ages 11 to 16 with severe pain, the agency says on its web site.
The child’s pain must be severe enough to require around-the-clock, long-term treatment and not managed well by other treatments. OxyContin is the brand name for a time-release formula of oxycodone, a narcotic painkiller.
Studies requested by the FDA from the drugmaker of safety in children and teens supported the approval, Sharon Hertz, MD, director of the Division of Anesthesia, Analgesia, and Addiction Products at the FDA’s Center for Drug Evaluation and Research (CDER), says in a "CDER conversation" posted on the FDA web site.
"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” after surgery or trauma, she says. Unlike adults, children must already be taking and tolerating a minimum dose equal to at least 20 milligrams of oxycodone per day for 5 consecutive days before they can be prescribed an equivalent dose of OxyContin, Hertz says.
"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 says.
"OxyContin is not intended to be the first opioid drug used in pediatric patients, but the data show that changing from another opioid drug to OxyContin is safe if done properly," Hertz says.
The warnings and precautions for children taking this drug are the same as for adults.
The FDA will require Purdue Pharma to do postmarketing studies aimed at finding out the safe use of OxyContin in children.