FDA: OxyContin OK For Kids As Young as 11

The U.S. Food and Drug Administration announced on Thursday that it has given the green light for doctors to prescribe OxyContin to kids as young as 11 in need of a painkiller.

OxyContin is an extended-release version of the prescription drug oxycodone. Both are opioids; powerful drugs that mimic heroin’s effects on the brain. They can help with pain management when used properly, the agency noted on its website. Both drugs, however, are often misused and are known to be highly addictive.

The FDA’s limited-use approval in children was based on studies conducted by the drug’s manufacturer, Purdue Pharma of Stamford, Conn.

“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,” Dr. Sharon Hertz, an FDA director, said in the announcement. “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.”

The drug, Hertz noted, should only be prescribed to children who have shown they can tolerate other opioid drugs over the course of five consecutive days.

What are your thoughts on the FDA’s decision? Share them by commenting below.

Opioid drugs, such as OyxContin, oyxcodone and Vicodin, are heavily regulated and have been linked to America’s “prescription pill epidemic,” which had a reported epicenter right here in Florida.

“Florida’s dubious distinction as the ‘epicenter’ of the nation’s ‘pill mill’ epidemic was solidified in 2010” when a federal law enforcement report noted that 98 of the Top 100 oxycodone dispensing doctors practiced in the Sunshine State, Florida Attorney General Pam Bondi said on her agency’s website. “Today, none of the top 100 dispensing physicians reside in Florida.”

Florida created a statewide Prescription Drug Monitoring Program in 2009 to crackdown on the epidemic.

Opioids are connected to an average of 44 deaths in the United States each day, the U.S. Centers for Disease Control and Prevention reports.

Despite the potential dangers of opioid use, Hertz said these drugs can prove beneficial for children who are in need of pain management assistance.

“In pediatric patients who require opioid treatment to manage pain, extended-release opioids may be a useful alternative because they are taken only once or twice per day rather than every 4 to 6 hours,” she said. “Fewer daily doses may free patients for physical therapy appointments, allow them to go home from the hospital sooner, and may help them to sleep through the night without waking up from pain. So from that perspective it’s very useful.”

A full question-and-answer session with Dr. Hertz is available on the FDA’s website.

Image via Shutterstock