FDA Approves OxyContin for Pediatric Patients 11 to 16 Years Old

OxyContin is a long-release version of oxycodone, an opioid that acts on the brain like heroin and is intended for only the most severe and chronic pain cases. The FDA asked the manufacturer of OxyContin, Purdue Pharmaceuticals, to conduct the studies, Hertz said.

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.

To avoid risk of overdose in patients who haven’t already been exposed to the drug, OxyContin will only be prescribed to children who can already tolerate a minimum dose of 20 milligrams of oxycodone, its drug ingredient.

With OxyContin becoming harder to abuse, intense studies being done, and regulations being set, the FDA decided that it was officially safe to allow for children with severe pain. Because OxyContin is an extended-release form of oxycodone, it requires fewer and less frequent doses to effectively manage pain-a function that Hertz sees as “useful” for its new pediatric use. The approval was made after reviewing safety data from the drug’s manufacturer.

An FDA spokesman said as a condition of the new approval, the agency is requiring Purdue to submit data in the coming years characterizing how OxyContin is being used in children aged 17 and younger. Widespread use of opioids in recent decades has helped spark what public-health officials call an epidemic of painkiller abuse in the U.S., including soaring rates of overdose deaths. However, some experts voiced their concerns about potential drug abuse of teenagers.

“Among adolescents who are prescribed OxyContin, a small but significant number are going to become addicted”, said Scottt Hadland from Boston Children’s Hospital and Harvard Medical School.

While opiates are very addicting, Little said prescriptions have to be given out by doctors on a particular kind of form that displays their name and bar codes printed for security – in addition to other measures.

Children will not be often prescribed with opioids; therefore, Hertz stated their…

The FDA notes that the Duragesic patch, which releases fentanyl, is the only other opioid approved for children. “There was so little that was evaluated in children that physicians were using medication that wasn’t studied”, she said.