Children aged 11 to 16 suffering from severe, long-term pain can now be given OxyContin, a powerful painkiller, as it has been approved for kids' use by the U.S. Food and Drug Administration (FDA).
What is OxyContin? Sharon Hertz, M.D., Director of the Division of Anesthesia, Analgesia, and Addiction Products in the Center for Drug Evaluation and Research via the FDA's website.
"OxyContin is an extended-release version of the opioid medicine, oxycodone. Opioids are powerful medications that can help manage pain when they are prescribed and used properly," Hertz says.
OxyContin, as an extended-release opioid, is used to treat patients that require round-the-clock medical management to help them with their severe pain. Extended-release opioids are used to manage pain in adults, ranging from lower back pain, osteoarthritis to cancer-related pain.
However, this medicine hasn't been approved for use in children before. The Associated Press reports that the FDA asked OxyContin maker, Purdue Pharma, to study how to safely and effectively use the drug in kids.
"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," says Hertz via FDA.
According to the Associated Press, the study involves prescribing the medicine to child patients that are expected to require the use of opioids in managing pain for many weeks. Such kids have experienced trauma or surgeries (i.e., spinal surgery) to correct birth defects.
The results of the study gave data that would give doctors more information on how to safely manage pain in their pediatric patients and also supported the addition of a pediatric indication to the OxyContin label for patients 11 to 16 years old, providing much-needed data to health care practitioners.
Hertz, per the FDA website, adds that child patients to whom OxyContin will be administered to must, unlike adults, "already be responding to, and tolerating a minimum opioid dose equal to at least 20 mg of oxycodone per day before they can be prescribed an equivalent dose of OxyContin."
"This way, the doctor knows that their patient tolerates and responds appropriately to opioids and knows the amount of opioid treatment needed to manage the patient's pain," she adds.
Duragesic, which releases fentanyl, is another opioid that the FDA has approved for use by children.
According to USA Today, OxyContin has been widely abused, and people looking for a "high" from the medicine have been reportedly crushing the pills so that it can be snorted or taken intravenously.
Purdue Pharma made it difficult to abuse through a reformulation in 2010, replacing the old formulation that has been long associated with addiction, overdose, and death.
