Zee Media Bureau
Washington: The US Food and Drug Administration has approved limited use of powerful painkiller OxyContin for children as young as 11 years old.
The agency on Thursday said that studies by Purdue Pharma of Stamford, Connecticut, which manufactures the drug, supported a new pediatric indication for OxyContin in patients 11 to 16 years old, providing prescribers with helpful information about the use of OxyContin in pediatric patients.
OxyContin is a long-release version of oxycodone, an opioid that acts on the brain like heroin and is intended for only the most severe and chronic pain cases.
"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,” said Dr Sharon Hertz, director of new anesthesia, analgesia and addiction products for the FDA.
Putting strict limits on the use of OxyContin in children, the FDA directs doctors to only prescribe OxyContin to children who can already tolerate a minimum dose of 20 milligrams of oxycodone (the drug ingredient in OxyContin) for five consecutive days.
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 warnings and precautions for pediatric patients taking OxyContin are the same as for adults.