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]
Read: How Painkillers Kill more than Heroin and Cocaine Combined
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]
But, inevitably, some children will become addicted to OxyContin, and the older the child, the greater the risk becomes. Andrew Kolodny, director of Physicians for Responsible Opioid Prescribing, warns that putting children on the painkiller for short-term medical needs, in particular, could increase their risk of dependence on the drug. The human brain doesn’t fully mature until about the age of 25, which puts teens at a higher risk of addiction than adults. [2]
Scott Hadland, a specialist in adolescent medicine and substance abuse treatment at Boston’s Children’s Hospital and Harvard Medical School, says that studies show that about one in 25 high school seniors has abused OxyContin.
“Among adolescents who are prescribed OxyContin, a small but significant number are going to become addicted,” Hadland said. [2]
OxyContin is a highly addictive drug that was once a favorite among addicts for its ability to be crushed and snorted or injected, earning it the nickname “Hillbilly Heroin.” In 2010, the drug was reformulated to make the process more difficult. [2]
The FDA says the health warnings associated with OxyContin are the same for adults and children. Doctors are instructed not to combine the drug with any other medications that could enhance its sedating effects, which could lead to breathing difficulties. [2]
In agreeing to approve OxyContin, the FDA says it will require Purdue to conduct a follow-up study examining rates of injury, overdose, accidents, and medication errors in patients ages 11 to 17. The results of the study are due April 2019. [2]
What do you think about the recent approval?
[1] WCVB 5
[2] USA Today