WASHINGTON – The Food and Drug Administration has approved the powerful painkiller OxyContin for a new use in children 11 to 16 suffering from severe, chronic pain.
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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.
Under the approval announced Thursday, prescribers are directed to only prescribe OxyContin to children who can already tolerate another opioid. Taking a sudden dose of an opioid can lead to overdose and death if patients haven't previously been exposed to the drugs.
The FDA notes that the Duragesic patch is the only other opioid approved for children.