- The label for OxyContin (oxycodone) has been expanded to include some children between the ages of 11 and 16.
- The only children who doctors can prescribe OxyContin for are those who can tolerate a minimum of 20 milligrams of oxycodone and who have not responded sufficiently to other medications.
- The version of OxyContin is a reformulated version, versus the original version (which was formulated nearly 20 years ago). In fact, doctors have been prescribing the medication off-label to children for some time.
According to the Institute of Medicine, about 100 million Americans suffer from chronic pain. Some of these patients, including adolescents, have chronic pain that can only be alleviated with around-the-clock, long-term opioid treatment. Now that Purdue Pharma's OxyContin is available in an abuse-deterrent formulation, the FDA has broadened the label to include 11-to16-year-olds, a population that could be vulnerable to addiction and abuse. As part of the approval, the FDA has requested that Purdue conduct postmarketing studies.
Chronic pain is very real and very debilitating. Currently, there are only two long-acting opioid treament options to manage pediatric pain, including the duragesic patch, which releases fetanyl. Now with the approval of OxyContin for this population, young people in pain now have another choice—and that's a good thing.