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FDA approves limited OxyContin use in children

Published on 17/08/15 at 09:49am

The FDA has approved the limited use of the strong painkiller Oxycontin for children in the US aged between 11 and 16.

OxyContin is an extended-release version of the opioid medicine oxycodone, which is used to manage chronic pain when other treatments have proven ineffective.

By extending its license to include children, Purdue Pharma, the manufacturer of OxyContin in the US, qualifies for an additional six months' of patent exclusivity. Some 17,000 paediatric prescriptions were written for OxyContin in 2011, less than 1% of the US market. However an extra six months of OxyContin monopoly could give Purdue an extra $1.4 billion in sales.

In an online post on the FDA website, Dr Sharon Hertz, director of the division of anesthesia, analgesia, and addiction Products in the FDA’s Center for Drug Evaluation and Research explained the Administration’s decision and reasoning.

OxyContin's is known to cause problems with addictive behaviours and abuse of the drug, prompting concerns about the drug’s availability 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 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.”

“To give health care providers more information on the safe use of drugs in pediatric patients… 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.”

OxyContin becomes only the second extended-release opioid approved for use in children, along with Duragesis (fentanyl).

Joel Levy

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