The Alliance for Patient Access / IfPA’s Patient Access Policy Blog / FDA’s Oxycodone Decision Offers New Prescribing Information for Treating Kids

FDA’s Oxycodone Decision Offers New Prescribing Information for Treating Kids

by Amanda Conschafter, blog editor

Physicians who prescribe opioid analgesics for kids with severe pain will now have the benefit of FDA guidance on pediatric dosing and safety. The FDA recently approved an extended-release form of the prescription pain reliever oxycodone for children age 11 and older.

Physicians sometimes prescribe the medication for children with pain that cannot be tempered by other medications – for instance, to treat car accident injuries, or chronic or migraine headaches. But in the past physicians have prescribed the medication off-label, relying upon prescribing information designed for adult patients.

The FDA’s approval came after the medication’s manufacturer submitted safety and efficacy data from clinical trials conducted with children. Regulators stress that the decision is “not intended to expand or otherwise change” prescribing patterns, but to better inform the prescribing that already occurs.

That information may be well timed. New data suggests that heading back to school corresponds to a spike in headaches among the estimated 10.3 million American children who suffer from them. The Nationwide Children’s Hospital recently reported that emergency room visits by children with headaches spiked 31 percent in the fall.

Though parents can help ward off some headaches by ensuring adequate sleep and fluid intake, the National Headache Foundation reports that five percent of kids face migraine headaches. These can be accompanied by nausea and vomiting and may require treatment with medication.

For families whose children need prescription pain medication for headaches or other conditions, the FDA reiterates the importance of safe storage and proper disposal. It has also requested additional data in the coming years on extended-release oxycodone’s use among pediatric patients and any related adverse events.

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