FDA approves OxyContin for children 11 and younger

The Food and Drug Administration (FDA) has approved the use of painkiller OxyContin for kids between the ages of 11 and 16 who are suffering from severe pain, USA Today reports.

“These studies supported a new pediatric indication for OxyContin in patients 11 to 16 years old, and provided prescribers with helpful information about the use of OxyContin in pediatric patients”, Dr. Sharon Hertz, director of new anesthesia, analgesia and addiction products for the FDA wrote the announcement.

In addition, doctors should only prescribe OxyContin in children who have already been treated with opiate painkillers and can tolerate at least 20 milligrams a day of oxycodone.

In the study, OxyContin were administered in children at a time where prolonged need for opioids is anticipated such as after a significant trauma or during the postoperative phase of major surgeries involving the spine or correction of birth defects. “Prior to this action, doctors had to rely on adult clinical data to shape their decision-making in treating pediatric patients”. According to the agency, the manufacturing pharmaceutical brand of the drug was able to show valuable data that proved the medicine’s safety in pediatric patients if appropriately administered. The National Institute on Drug Abuse (NIDA) has previously stated that prescription opioids like OxyContin are “addictive” and could lead to heroin use.

Additionally, the same health warnings that apply to adults taking OxyContin will apply to children who take it and follow-up studies will be conducted as a condition of approval.

In a question-and-answer posting on the FDA’s site, the head of the agency’s painkiller division stressed that OxyContin’s new pediatric approval “was not intended to expand or otherwise change the pattern of use of extended- release opioids in pediatric patients”, but to better inform prescribing that was already taking place in children.

OxyContin has a bad reputation for being abused by patients who would sometimes crush the tablets and then snort or inject it for a faster – and more unsafe and addicting – high.

The only other long-acting opioid option for pediatric pain management is the duragesic patch, which releases an opioid called fentanyl through the skin. OxyContin is still listed as a Schedule II Drug by the DEA, meaning it does have medical applications, but the risk for psychological or physical dependence is still great.