On Aug. 13, 2015, the FDA approved OxyContin for 11-16 year olds. The FDA pointed out that physicians could already prescribe OxyContin off-label to this same group, and the studies done by Purdue Pharma in its application would allow physicians to know more about the effecs and side-effects of OxyContin at specific doses.
While the decision as described by the FDA seems benign enough, there are several aspects of the decision that are not benign:
1. 250,000 Americans have died in the opioid epidemic which began with increased medical use of OxyContin. The FDA has ignored the lack of knowledge of the likelihood that a patient started on opioids will eventually become addicted to opioids.
2. The scientific literature increasingly supports the view that early medical use of prescription opioids may lead to later nonmedical use. We do not know whether the late childhood and early adolescent brain is more vulnerable to opioid addiction; not to make this determination before approval is cavalier.
3. FDA approval essentially guarantees increased use for two reasons:
a. Insurers have grown increasingly unwilling to pay for non-approved medication; approval of a medication makes coverage more widely available.
b. Approval opens the door to marketing by Purdue Pharma for pediatric use of OxyContin.