TEEN HEALTH Published October9, 2015 By Bernadette Strong

OxyContin’s Approval for Children Getting Harsh Criticism

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The FDA is being criticized for approving the use of OxyContin in children because of its widespread abuse.
(Photo : Joe Raedle, Getty Images)

In August, the Food and Drug Administration approved the use of the OxyContin for children with serious pain issues. Since then, it has faced serious criticism from lawmakers and public officials because of the high rates of abuse of prescription opioid like OxyContin in many parts of the country.

Many fear that the FDA's approval for children will lead to more prescriptions for OxyContin in young patients. OxyContin has been prescribed off-label to very sick children in severe pain from cancer or spinal-fusion surgery because doctors can prescribe any approved drug to any use, but the approval means that they now have specific prescribing information for children. OxyContin is a controlled-release version of the opioid pain reliever oxycodone.

Oncologists and other physicians who deal with young patients in serious and lasting pain have applauded the approval. The approval specifies that OxyContin should be used only for children 11 or older who are in severe, long-term pain and who have already treated with an opioid for at least 5 days. It is not supposed to be the first drug prescribed for pain, and it is not meant for short-term pain, like a sprained ankle.

Some drug industry observers are skeptical that Purdue Pharma, the maker of OxyContin, will not market the drug inappropriately. A spokesperson for Purdue Pharma said in a statement that the company will not promote the pediatric use of the drug. Purdue Pharma pleaded guilty in 2007 to federal charges that the company misled doctors, patients, and regulators about OxyContin's potential for abuse.

The FDA asked Purdue Pharma to conduct studies as part of a broader effort to accrue evidence about how drugs work in children differently from in adults. The agency is requiring that Purdue Pharma conduct post-approval studies to collect information about any adverse effects.

The company will also have to report nationally representative data on the volume of OxyContin prescriptions for children younger than 17, which types of physicians are prescribing it, and for what conditions.

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