The Food and Drug Administration has approved limited use of the powerful and frequently abused painkiller OxyContin for children as young as 11 years old, the agency announced Thursday.
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However, this medicine hasn’t been approved for use in children before.
In an interview with FDA director for anesthesia, analgesia and addiction medication Dr. Sharon Hertz, she noted that it is effective for managing chronic pain conditions based on an evaluation and study on OxyContin on pediatric patients under the Best Pharmaceuticals for Children Act (BPCA).
“This program was intended to fill a knowledge gap and provide experienced health care practitioners with the specific information they need to use OxyContin safely in pediatric patients”, she said. Doctors are directed to prescribe the Oxycontin only to patients who have severe pain without any other option, can tolerate the minimum dose of 20mg of oxycodone in five consecutive days and have already used opioids before. A sudden dose of opioid can possibly lead to overdose and death if patients have not previously been exposed to the drug so some restrictions are mandatory.
The only opioid approved for use among children is the Duragesic pach, which releases fetanyl.
Purdue Pharma, reporter Erin Shumaker pointed out, saw three of its executives plead guilty in 2007 to misleading doctors and regulators about the drug’s addiction risk.
Hertz’ also said that OxyContin will only be prescribed if pediatric patients have already received opioids for severe-pain management.
The FDA said Purdue must conduct a follow-up study to examine the rates of injury, overdose, accidents and medication errors in children taking the drug, with the report due in April 2019.
Doctors prescribe opioids for a wide range of ailments, from post-surgical pain to arthritis and migraines.
Some experts are concerned that younger patients could be more likely to get addicted to the drug.
A euphoric high is caused by stimulation of the reward center of the brain by oxycodone, which is similar to that of Similar to heroin.
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OxyContin was the first in a class of long-acting opioids designed to deliver powerful, around-the-clock pain relief.
