Oxycontin Receives Pediatric Dosing Approval

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Oxycontin (oxycodone ER) is an extremely strong prescription pain medication, previously approved for adult use only. Now, the FDA has also approved it for use in children 11 to 16 years of age.

The approval has caused some outrage, and has many people questioning why the FDA would allow such a powerful and addictive medication to be prescribed for young children.

On the other hand—children usually don’t experience the chronic type of pain that adults do, so the use of Oxycontin will be limited to a few specific, medically necessary situations. For example, it may be used to treat pain following surgery, or cancer pain.

What is Oxycontin prescribed for?
Oxycontin is used to manage pain severe enough to require daily, around-the-clock, long-term treatment and where alternative options are not sufficient.

Who can be prescribed Oxycontin?

Now, Oxycontin may be prescribed for adults and opioid-tolerant pediatric patients 11 years and older who are already receiving (and have a tolerance for) a daily dose of at least 20 mg of another pain medication, like oxycodone.

How is Oxycontin available?
Oxycontin is available as a tablet in 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg strengths.

Can Oxycontin be addictive?

Yes. Oxycontin is classified by the DEA as a schedule II http://www.deadiversion.usdoj.gov/schedules/ controlled substance. Schedule II controlled substances have a high potential for abuse which may lead to severe psychological and physical dependence.

Why would the FDA approve a medication like this for children?

Many of the medications indicated for pain relief in adults don’t conduct clinical trials in children. This means that there just isn’t enough information for health care professionals to be able to determine dosing and side effect profiles in younger age groups, even if the medication may be needed.

In the past, if your child’s doctor felt a strong pain medication was necessary, they were often left to base the dose on interpretation of the adult recommendations. This recent FDA approval comes following recent data from clinical trial specifically studying the use of Oxycontin in children.

Oxycontin is still not meant to be prescribed for children the same way as it is for adults. It’s meant to be reserved for major surgery or trauma—and for pediatric patients who have already been taking opioid medications to manage that severe pain.

For more information on the approval, and pain management for children, please see this Q&A from the FDA.

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