On Thursday, the FDA approved the powerful painkiller OxyContin for use in children ages 11 to 16 who have severe, long-term pain.
The extended-release opioid has been used for years to treat constant pain in adults, but it is one of the few prescription painkillers approved for children. The only other known opioid drug approved for use in children is Duragesic, or the fentanyl patch. [1]
Drug maker Purdue Pharma was approached by the FDA to study how to safely use OxyContin in youngsters. The agency sought to make the drug an option for children who suffer severe pain due to trauma, surgery, or cancer. Purdue had been working on OxyContin for child-use for years. [1]
“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,” Sharon Hertz, an FDA drug division director, wrote in an online post. [1]
The new approval means that doctors may only prescribe OxyContin to children who have already shown they can tolerate a minimum dose of 20 mg of oxycodone, the main ingredient in the painkiller. Patients who have never before been exposed to opioid drugs can overdose and die if they suddenly take one. [1]
“Children are not treated with opioids very often and usually it’s only for a limited period of time with close supervision by health care professionals,” said Sharon Hertz, a physician with the FDA’s Center for Drug Evaluation and Research. “Fewer daily doses may free patients for physical therapy appointments, allow them to go home from the hospital sooner and may help them to sleep through the night without waking up.” [2]
Justin Baker, a pediatric oncologist and hospice and palliative medicine doctor at St. Jude Children’s Research Hospital, agrees. He says having additional long-acting painkillers “is going to be tremendously helpful for treating children with cancer pain or pain at the end of life.” Long-acting and slow-release medications prevent breakthrough pain, allowing children to feel comfortable and “focus their energy on being a kid instead of fighting their pain,” Baker told USA Today. [2]
