Opioid Pain Rx Approved for Kids

OxyContin (oxycodone) approved for pain in children ages 11 to 16 by FDA

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) A powerful medication used for severe, chronic pain in adults just got the green light for use in kids.

On Thursday, the US Food and Drug Administration (FDA) approved oxycodone (brand name OxyContin) for use in children ages 11 to 16.

"Similar to adults, OxyContin is approved for use in these patients to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate," wrote Sharon Hertz, MD, director of the FDA's Division of Anesthesia, Analgesia, and Addiction, in a post on the FDA website.

While many painkilling drugs exist, few have been studied for managing pain in children, Dr. Hertz noted. That's why the FDA asked Purdue Pharma, the manufacturer of OxyContin, to study the drug in children. The studies Purdue conducted led the FDA to approve OxyContin to treat pain in children 11 to 16 years old.

OxyContin is a part of the class of drugs called opioids, which are used to treat pain from many conditions, such as cancer, surgeries and severe trauma, among others. This class of drugs is also well-known for its potential to spark opioid addiction and abuse, which can be deadly. What sets OxyContin apart, Dr. Hertz noted, is that the drug has recently been reformulated so that it is more difficult to crush or dissolve for illicit use.

Taking a sudden, first dose of a powerful opioid can lead to overdose, according to the Associated Press (AP). But doctors won't be prescribing OxyContin for kids right out of the gate.

"The major difference is that all pediatric patients that are considered for pain management with OxyContin should already have been treated with an opioid pain medicine," Dr. Hertz wrote. "This way, their health care providers know that these pediatric patients can be treated safely with OxyContin."

Other than OxyContin, the only other FDA-approved, extended-release opioid for kids is Duragesic (fentanyl), according to Dr. Hertz.

Although OxyContin was recently studied in children, the FDA is requiring Purdue to conduct further study in kids to assess safety and effectiveness. That study is due by April 2019, the AP reports.

Currently, the same health warnings about OxyContin use in adults apply to children, according to the FDA. For instance, the drug still should not be prescribed along with any drugs that also have a sedative effect.

Review Date: 
August 14, 2015
Last Updated:
August 19, 2015