Controversy erupts over pediatric OxyContin guidance
- Ever since the FDA broadened the label for Purdue Pharma's OxyContin (ER oxycodone) to include 11 to 16-year-olds in August, critics have been highlighting the dangers of addiction.
- The version of OxyContin is a reformulated version (the original was formulated nearly 20 years ago). Doctors have been prescribing the medication off-label to children for some time.
- Painkillers are the second most abused group of psychotherapeutics (after marijuana) among children aged 12 to 17, according to the Substance Abuse and Mental Health Services Administration.
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. When Purdue Pharma's OxyContin became available in an abuse-deterrent formulation, the FDA broadened the label to include 11-to16-year-olds—a population that could be vulnerable to addiction and abuse.
There are many officials and addiction specialists who assert that expanding access to a younger group of people could fuel an epidemic that is already burgeoning. They point to the fact that in 2013, there were 24,000 overdose deaths directly attributable to heroin and painkiller abuse. Also, children, whose brains are still developing, are more vulnerable to the effects of opioids.
Based on IMS estimates, last year roughly 1% of prescriptions written for OxyContin were for patients aged 19 and younger. Unfortunately, young people are stricken with diseases, such as terminal cancer, sickle cell anemia, and pain syndromes that require management. It all comes down to balance—but it may be a particularly tricky one to strike in this situation.