FDA Approves Opioid Medicine OxyContin For Children Aged 11 To 16

FDA Approves Opioid Medicine OxyContin For Children Aged 11 To 16
Sista pilleruttaget? Patrick Strandberg / Flickr CC BY-SA 2.0

Recently, the U.S. Food and Drug Administration’s (FDA) Sharon Hertz, M.D. has revealed that they had spoken with the manufacturer of pain management drug OxyContin to evaluate the possibility and safety of administering the said drug on younger patients. And now, the director of FDA’s Division of Anesthesia, Analgesia and Addiction Products, Office of New Drugs, Center for Drug Evaluation has said that the said studies have shown the possibility of a new pediatric indication for OxyContin for patients that are aged 11 to 16.


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Hertz acknowledged that the number of children who are suffering pain due to cancer, extensive trauma as well as surgeries are actually “not many.” However, for those in a lot pain, there are only a few pain management products that readily provide information with regard to safety and effectiveness when administering to children. This leads doctors to rely on experience in order to determine the right pain management drug dosage for their pediatric patients.

Hertz says that OxyContin can readily help a child manage pain when prescribed and used properly. OxyContin is actually an extended-release version of oxycodone. And since it is an extended release opioid medicine, it only needs to be taken around every 12 hours. In contrast, an immediate-release opioid usually needs to be taken every 4 to 6 hours. Moreover, Hertz believes that extended-release opioid products are less likely to be abused and misused by patients.

Under the Best Pharmaceuticals for Children Act (BPCA) of 2002, the FDA issued a Pediatric Written Request to makers of the OxyContin to study oxycodone and OxyContin in pediatric patients. This study resulted in data that will now allow doctors to prescribe OxyContin to pediatric patients safely, following surgeries or trauma.

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There is one requirement for a child to be prescribed OxyContin

For a pediatric patient to be prescribed OxyContin, however, Hertz clarified that the said patient should already be “tolerating” a minimum opioid dose of at least 20 mg of oxycodone a day. This way, the doctor will know that the child patient already responds “appropriately” to opioids.

Once prescribed, OxyContin can be administered by parents and/or caregivers to children at home. OxyContin can readily be purchased at the pharmacy.

Children may experience drug side effects

Meanwhile, the University of Michigan Health System warns that children tend to respond differently to opioids so parents and caregivers must watch carefully for side effects. These include dizziness, nausea, vomiting, constipation, drowsiness, itching and confusion. Moreover, a child may also suffer from respiratory depression. That is, the child may experience trouble breathing.