|
 The long-acting drug already treats adults suffering from
around-the-clock pain, and has been reformulated over the years to
combat rising prescription drug abuse in the United States.
Unlike adults, doctors are to prescribe the medicine only for
children who can already tolerate a minimum dose of 20 milligrams of
oxycodone, the active drug ingredient in OxyContin.
The warnings and precautions for pediatric patients are the same as
those for adults, the agency said on its website on Thursday.
OxyContin maker Purdue Pharma LP, which had been asked by the FDA to
evaluate the drug's use in children, will also conduct postmarketing
studies.
[to top of second column] |
The duragesic patch, which releases fentanyl, is the other
long-acting opioid option for pediatric pain management.
The original formulation of OxyContin, which was first approved
nearly two decades ago, was withdrawn due to its potential for
abuse.
(Corrects dateline to Aug 14 from Aug 13)
(Reporting by Natalie Grover in Bengaluru; Editing by Sriraj
Kalluvila)
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