FDA Approves Painkiller OxyContin for Children 11 and Older

FDA Approves Painkiller OxyContin for Children 11 and Older
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August 17, 2015

The U.S. Food and Drug Administration (FDA) last week approved the painkiller OxyContin for use by children as young as 11 years old.

With minimal research on the effects of opioid treatment in pediatric patients, the approval comes after studies showing how OxyContin could be used safely by children between 11 and 16 years old. Due to the lack of pediatric data, doctors often have to use adult clinical data to make prescribing decisions.

"This program was intended to fill a knowledge gap and provide experienced health care practitioners with the specific information they need to use OxyContin safely in pediatric patients," wrote the FDA on its website.

OxyContin is the extended-release version of the opioid medicine, oxycodone. Oxycodone is an immediate-release drug that is taken every four to six hours to treat severe pain. Long-term or chronic pain can be treated with OxyContin, which is instead taken every 12 hours.

Children suffering long-term pain must already be taking and tolerating another opioid that is the equivalent of 20mg of oxycodone before they can be prescribed the powerful painkiller.

Fortunately, children are less likely than adults to need long-term pain management, but those that might include children with cancer, those who experienced extensive trauma, and those that underwent major surgery.

Fentanyl is the only other extended-release opioid that has FDA-approved labeling for pediatric use. Some immediate-release medicines also have pediatric information on their labels.

Keeping Your Family Safe from Abuse

OxyContin is a highly addictive drug and with that comes the risk for abuse by the patient or anyone else that could have access to the patient's medication.

Like many extended-release painkillers, the chemical composition of OxyContin is such that abusers trying to crush or dissolve the medication won't achieve the high that they're looking for. This, however, doesn't stop an addicted person from taking the medication as directed.

Because of its addictive properties, OxyContin shouldn't be stored in a medicine cabinet next to the Tylenol. It should be stored in a secure location that can't be accessed by other children, siblings, friends, or other visitors.

Children who no longer need to take the drug should be weaned off the medication slowly so they don't experience withdrawal symptoms. If additional medications are added, parents, doctors, and pharmacists should take care to ensure that new medications won't add to OxyContin's sedating effects or have any other adverse reactions.

More information can be found on the FDA website.