Oxycontin has been approved by FDA for kids with severe chronic pain

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Oxycontin has been approved by FDA for kids with severe chronic pain

The Food and Drug Administration has approved the painkiller OxyContin for a new use in children 11 to 16 suffering from severe, long-term pain.

OxyContin is an extended-release opioid used to treat around-the-clock pain in adults, but most painkillers are not approved for children. Drug maker Purdue Pharma was asked to study the safe use of OxyContin in children. “This program was intended to fill a knowledge gap and provide experienced health care practitioners with specific information they need to use OxyContin safely in pediatric patients,” Sharon Hertz, an FDA drug division director.

Under the new approval, doctors are directed to only prescribe OxyContin to children who can tolerate a minimum dose of 20 mg of oxycodone, drug ingredient in OxyContin. Sudden dose of an opioid can cause overdose and death. Duragesic patch, releasing fentanyl, is the only other FDA approved opioid for children.

OxyContin was re-formulated in 2010 to discourage patients from crushing the tablets for snorting or injection. Purdue Pharma discontinued the older version of its blockbuster drug, due to problems of addiction, overdose and death. The same health warnings apply to adults and children taking OxyContin. The drug should not be combined with any other medications that add to its sedating effects, causing breathing difficulties.

As a condition of approval, the FDA is requiring Stamford, Connecticut-based Purdue to conduct a follow-up study examining rates of injury, overdose, accidents and medication errors in patients ages 11 to 17. The final study is due April 2019. Doctors prescribe opioids for various ailments, from post-surgical pain to arthritis and migraines. Medical experts disagree over the appropriate role of the drugs. Some argue that they should be reserved for most severe cases, like cancer pain or end-of-life care. FDA mentions severe pain due to trauma, surgery or cancer as potential uses for opioids in children.

OxyContin was the first class of long-acting opioids designed to deliver powerful, around-the-clock pain relief. The pills and tablets are formulated to slowly release drug over 12 or more hours. But abusers get heroin-like high by releasing the entire dose at once via chewing, snorting or injecting crushed tablet contents.

U.S. Food and Drug Administration
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