By Pat Anson, Editor

In a controversial move, the U.S. Food and Drug Administration has approved OxyContin for use by children aged 11 to 16 who suffer from severe, long-term pain.

OxyContin is a potent, extended release opioid painkiller that has been blamed for fueling an “epidemic” of prescription drug abuse and addiction in the U.S.

One critic, whose teenage daughter died after a single dose of OxyContin, called the FDA’s decision “beyond disgusting.”

The agency did not make a formal announcement about its decision, issue a news release, or consult with an outside advisory panel about the risks and benefits of making OxyContin available to pediatric patients.

Instead, the news was revealed in an FDA blog posting, an interview with Sharon Hertz, MD, a Director in the FDA’s Center for Drug Evaluation and Research.

“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,” Hertz said.

“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. 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.”

Hertz said the FDA decision was a "team effort" involving physicians, pediatricians, clinical pharmacologists, statisticians, ethicists and opioid experts. It came after the safety and efficacy of OxyContin was studied in children who were prescribed the drug after extensive trauma or major surgery. 

“Prior to this action, doctors had to rely on adult clinical data to shape their decision-making in treating pediatric patients. This program was intended to fill a knowledge gap and provide experienced health care practitioners with the specific information they need to use OxyContin safely in pediatric patients,” said Hertz.

She said OxyContin should only be prescribed to pediatric patients when they have shown they can tolerate a 20 mg daily dose of oxycodone, an immediate release opioid.  

The Duragesic patch, which contains fentanyl, is the only other extended release opioid product approved for use by children.

Hertz hinted the FDA would be approving more opioids for pediatric patients in the future.

“Quite a few of the newer opioid drugs have pediatric studies underway to gather the data that will help prescribers use them safely. I expect that our teams will be working together a lot more in future to make sure that new pediatric pain management options continue to be safe for children in the U.S.,” Hertz said.

OxyContin has a controversial history. It was introduced to the U.S. in 1996 and soon became a blockbuster drug for Purdue Pharma, reportedly generating profits in excess of $10 billion.

In 2007, Purdue and three of its top executives pleaded guilty to felony criminal charges for the off-label marketing of OxyContin – falsely telling doctors it had low potential for addiction.

Critics, who blame Purdue for thousands of fatal OxyContin overdoses, are angry about the FDA's decision to approve the drug for children.

“We've known for a long time how immoral this company is.  As far as Purdue's role, this comes as no surprise; they have had this idea for some time now, as it represents a very lucrative market for them,” said Pete Jackson, president of Advocates for the Reform of Prescription Opioids.

Jackson lost his 18-year-old daughter Emily to a single dose of OxyContin in 2006.

“We've also known for a long time how unethical the FDA is,” Jackson said in an email to Pain News Network.  “This brings both truths out in the open.  This is the pinnacle of dysfunction in our federal government: that a federal agency would openly sanction the use of a deadly narcotic on kids without even an advisory committee meeting to hear from the experts and the public is beyond disgusting.”

By 2010, nearly half the patients entering drug treatment facilities for opioid abuse said they had used OxyContin to get high at least once in the previous 30 days. That same year Purdue introduced a reformulated version of OxyContin to discourage patients from crushing the tablets for snorting or injection.

As a condition of its approval for use in pediatric patients, Purdue is required to conduct a follow-up study examining rates of injury, overdose, accidents and medication errors involving OxyContin in pediatric patients.