The U.S. Food and Drug Administration (FDA) decided that children between 11 and 16 years old, who did not benefit enough from other pain management alternatives, can be prescribed the opioid painkiller OxyContin.
The FDA asked Purdue Pharma, the manufacturer of the drug to conduct studies that would determine the safety of OxyContin for use by pediatric patients and found that it could be safely taken by patients between 11 and 16 years old.
Although the decision was hailed by doctors treating young cancer patients, others were concerned that prescribing OxyContin to young patients can place them at risk for addiction.
OxyContin, a narcotic pain reliever with morphine-like effects, is already prescribed to adults who suffer from round-the-clock pain but the drug, an extended-release version of the opioid oxycodone, already gained notoriety because it is frequently abused.
Those who become addicted to painkillers snort and inject the crushed pills to produce a powerful high. Physicians for Responsible Opioid Prescribing director Andrew Kolodny said that prescribing the opioid painkiller to young patients with short-term medical needs may possibly lead to addiction.
Teens have increased odds for addiction compared with adults because the brain does not mature until the age of 25. Studies, in fact, have shown that about one in 25 high school seniors has abused OxyContin.
The FDA said that because of the addictive risks associated with opioid pain medication, they have urged drug makers to make extended-release medications more resistant to abuse and misuse. The agency said that OxyContin is different from other drugs in its class in that it has been reformulated to prevent it from being abused.
Just like with adults, the use of OxyContin in pediatric patients is approved for management of pain that is severe enough. It needs daily, round the clock and long term treatment of opioid medicine when other treatment options are inadequate.
In young patients though, doctors can only prescribe the medicine for those who have already been treated with an opioid painkiller and can tolerate a minimum dose of 20 milligrams of oxycodone, the active ingredient in OxyContin.
"This way, the doctor knows that their patient tolerates and responds appropriately to opioids and knows the amount of opioid treatment needed to manage the patient's pain," explained Sharon Hertz, from FDA's Office of New Drugs, Center for Drug Evaluation and Research. "When appropriate, the doctor can then convert their patient over to an OxyContin dose that is tailored to their individual needs."
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