FDA Approves Limited OxyContin use in Children

OxyContin is an extended-release version of the opioid medicine oxycodone, which is used to manage chronic pain when other treatments have proven ineffective. It has now been approved by the FDA for the use in children between 11-16 years within limited use.

OxyContin’s is known to cause problems with addictive behaviours and abuse of the drug, prompting concerns about prescribing the drug to younger children. To try and manage this risk, all children that are considered for pain management with OxyContin should already have been treated with another opioid pain medicine. Unlike adults, children who will be prescribed Oxycontin must already be responding to, and tolerating a dose of at least 20 milligrams of oxycodone a day before they can be prescribed an equivalent dose of OxyContin.

Dr Hertz, director of the division of anaesthesia, analgesia, and addiction Products, says that while few children experience the types of pain associated with requirement of drugs like OxyContin, in the cases where it was necessary, doctors were often forced to “rely on their own experience to interpret and translate adult data into dosing information for pediatric patients.”

She added “We requested the manufacturer of the pain management drug OxyContin perform studies evaluating safety and other important information about oxycodone and OxyContin when used in pediatric patients..These studies supported a new pediatric indication for OxyContin in patients 11 to 16 years old, and provided prescribers with helpful information about the use of OxyContin in pediatric patients.”


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