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FDA approves OxyContin for kids 11 to 16

USA TODAY logo USA TODAY 8/14/2015 Liz Szabo
In this Feb. 19, 2013, file photo, OxyContin pills are arranged for a photo at a pharmacy in Montpelier, Vt. © AP Photo/Toby Talbot In this Feb. 19, 2013, file photo, OxyContin pills are arranged for a photo at a pharmacy in Montpelier, Vt.

Doctors can prescribe the powerful narcotic painkiller OxyContin for children as young as 11, the Food and Drug Administration said.

OxyContin, an extended-release version of the painkiller oxycodone, has gained notoriety in recent years because of its frequent abuse. People addicted to painkillers crush the pills so that they can be snorted or injected, producing a powerful high.

Children generally have fewer options for pain relief than adults. The FDA asked the manufacturer of OxyContin to perform studies to see if the drug could be used safely in children ages 11 to 16 suffering from pain caused by cancer, trauma or major surgery, said Sharon Hertz, a physician with the FDA's Center for Drug Evaluation and Research, in an interview on the agency's web site. The FDA approved OxyContin for children this age who need "daily, round-the-clock, long-term" pain relief. Doctors should only prescribe OxyContin in children who have already treated with opiate painkillers and who can tolerate at least 20 milligrams a day of oxycodone, Hertz said.

Children have few options for extended-release, long-acting pain relief, Hertz said. Other than OxyContin, the only other drug of this kind approved for children is Duragesic, also known as fentanyl. Fentanyl is also being increasingly abused and has led to a spike in fatal overdoses.

In 2010, Purdue Pharma reformulated OxyContin to make it more difficult to abuse. But health officials remain concerned about abuse of opiates, a class of morphine-like painkillers. The number of prescription painkillers sold in the USA has quadrupled since 1999, according to the Centers for Disease Control and Prevention. More than 44,000 Americans die of drug overdoses each year. Some people who become addicted to prescription painkillers switch to using heroin, which has become cheaper and easier to access than OxyContin.

"Children are not treated with opioids very often and usually it's only for a limited period of time with close supervision by health care professionals," Hertz 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."



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