The Food and Drug Administration on Thursday approved the powerful painkiller OxyContin for a new use in children 11 to 16 who are suffering from severe, long-term pain.
OxyContin is an extended-release opioid that has long been used to treat around-the-clock pain in adults. But most pain medications are not approved for use in children.
The FDA says it asked drugmaker Purdue Pharma to study how to safely use OxyContin in children.
"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," Sharon Hertz, an FDA drug division director, wrote in an online post.
Under the new approval, doctors are directed to only prescribe OxyContin to children who can already tolerate a minimum dose of 20 milligrams of oxycodone, the drug ingredient in OxyContin. Taking a sudden dose of an opioid can lead to overdose and death if patients haven't previously been exposed to the drug type.
The FDA notes that the Duragesic patch, which releases fentanyl, is the only other opioid approved for children.
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OxyContin was re-formulated in 2010 to discourage patients from crushing the tablets for snorting or injection. Purdue Pharma discontinued the older version of its blockbuster drug, which was long associated with problems of addiction, overdose and death.