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FDA Approves Use of OxyContin in Children Aged 11 to 16 Years
The FDA has approved the use of the opioid painkiller OxyContin (Purdue Pharma) in children 11 to 16 years of age who have not benefited from alternative therapies, according to a Reuters report.
The long-acting drug was previously approved for adults with around-the-clock pain, and has been reformulated over the years to combat rising prescription drug abuse in the U.S.
Doctors are to prescribe the painkiller only for children who can already tolerate a minimum dose of 20 mg of oxycodone, the active ingredient in OxyContin. The warnings and precautions for pediatric patients are the same as those for adults.
Purdue Pharma, which had been asked by the FDA to evaluate the drug’s use in children, will also conduct postmarketing studies.
The Duragesic patch (Janssen Pharmaceuticals), which releases fentanyl, is the only other long-acting opioid option for the management of pediatric pain.
The original formulation of OxyContin, which was first approved nearly 20 years ago, was withdrawn because of its potential for abuse.
Source: Reuters; August 14, 2015.