FDA Approves OxyContin for Treating Pain in Kids

The US Food and Drug Administration (FDA) announced Thursday their approval for the prescription of painkiller OxyContin in pediatric patients as young as 11 years old.

According to an interview with FDA director for anesthesia, analgesia and addiction medication Dr. Sharon Hertz, an evaluation and study on OxyContin on pediatric patients under the Best Pharmaceuticals for Children Act (BPCA) found that it is effective for managing chronic pain conditions. A report by ABC News confirms that the manufacturer of the opioid OxyContin, Purdue Pharma, was instructed to find out how to use it safely by the FDA.

"We requested the manufacturer of the pain management drug OxyContin perform studies evaluating safety and other important information about oxycodone and OxyContin when used in pediatric patients. 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," said Hertz.

OyxContin is a powerful narcotic analgesic drug and brand name for oxycodone. It is a highly addictive and controlled painkiller. WebMD says that it is used to treat pain for conditions including cancer, injuries, and arthritis. OxyContin usually contains 10 to 80 milligrams of oxycodone and is a time-release formula that induces 12 hours of pain-free relief.

Under the new approval, doctors are urged to only prescribe OxyContin to pediatric patients who have been tolerant of other opioid, which the FDA notes is only one other drug called Duragesic patch. The condition was made to emphasize the fact that overdose and death can result if patients have no prior exposure to the strong narcotics.

"We are always concerned about the safety of our children, particularly when they are ill and require medications and when they are in pain," Hertz said in the interview. "OxyContin is not intended to be the first opioid drug used in pediatric patients, but the data show that changing from another opioid drug to OxyContin is safe if done properly."

According to Fox News, the FDA warning for pediatric patients is also applicable for adult patients. The agency warned that the drug must not be mixed with other medicine or treatment regimen.

OxyContin is considered to be one of the most abused painkillers in the US. Due to its strong opioid qualities, many abusers use it to get a heroin-like high through ingestion, snorting, or injecting the crushed tablets to their system, according to the National Institute on Drug Abuse.