In a decision that drew the ire of everyone from leaders in the medical community to members of Congress, the FDA recently approved the use of OxyContin for use in children as young as eleven years old.
An incredibly powerful opioid, OxyContin is highly addictive and can be lethal at high doses. And, when the nation is already in the throes of a prescription drug abuse and overdose crisis, the thought of opening children to such risks is, to most, unconscionable.
It may have been the volume of vitriol spewed in their direction but the FDA has made the uncommon move of responding to the attacks. A Washington Post Health and Science report gives a deeper analysis of the subject while also quoting sources within the Food and Drug Administration on why they took this step in pain relief for children.
The agency states that their approval wasn’t given in an effort to widen the use of opioids in children. Instead, the intent was to provide doctors with a better set of standards where the use of opioids in children would be deemed acceptable. Agency spokespeople state that doctors have been prescribing opioids such as OxyContin for children for a long time; as doctors are permitted to prescribe whatever drugs and medications they see fit for a given patient and their specific situation.
However, much of this use is off-label; or for uses other than what has been officially approved by the FDA.
Critics of the FDA decision continue their sharp criticism of the agency regardless of the explanation. New York psychiatrist and director of Physicians for Responsible Opioid Prescribing Andrew Kolodny does not hesitate to bring up Oxycontin manufacturer Perdue’s previous legal troubles regarding the marketing of the drug.
In 2007, several Perdue executives pleaded guilty to charges of falsely marketing OxyContin in such a way that the addiction and abuse risks of the drug were significantly downplayed. In Kolodny’s eyes, putting this company in the position to now potentially market its drug for use in minors opens brand new doors to abuse.
The FDA’s strategy for regulating this move appears to rely largely on Perdue’s ability to regulate, police, and report on its own findings. The director of the agency’s division for anesthesia, analgesia, and addiction products says that Perdue themselves will be required to conduct studies to determine how widely their drug is being used in these younger patients.
Responsible use of medication should be at the forefront of every medical professional’s mind and physicians treating young patients should take a look at available data on OxyContin’s ability to control chronic, high-level pain in young patients as well as the risks. The consequences of this newly approved use remains to be seen.