The Food and Drug Administration announced Thursday it has approved the use of the powerful and frequently abused opioid painkiller OxyContin for children ages 11 to 16 who suffer from severe long-term pain.
The decision came after the FDA asked drugmaker Purdue Pharma to study if and how OxyContin could be safely used by children, reported the Associated Press. Those studies "supported a new pediatric indication for OxyContin in patients 11 to 16 years old and provided prescribers with helpful information about the use of OxyContin in pediatric patients," Dr. Sharon Hertz, an FDA director of new anesthesia, wrote in an online post.
"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," she said.
OxyContin is a controversial extended-release version of the painkiller oxycodone, acting on the brain like heroin, and intended only for the most severe cases of pain. It's gained notoriety in recent years due to its frequent abuse, with addicts sometimes crushing the pills so they can be snorted or even injected to produce a more powerful high, explained USA Today. Most pain medications are not approved for use in children, the only other opioid approved for children being the Duragesic patch, which releases fentanyl.
The FDA said children with pain due to trauma, surgery or cancer could potentially qualify to receive the drug.
The new approval stipulates that doctors can only prescribe OxyContin to children who can already tolerate 20 milligrams of oxycodone, an ingredient in OxyContin. Without such a tolerance, taking a sudden dose of an opioid can result in overdose and death, according to the AP.
The Centers for Disease Control and Prevention said the U.S. is currently in the midst of a prescription drug overdose epidemic, largely due to painkillers being prescribed and sold at rates quadruple what they were in 1999. Each day, 44 people in the United States die from an overdose of prescription drugs, according to the CDC.
"We are always concerned about the safety of our children, particularly when they are ill and require medications and when they are in pain," said Hertz. "OxyContin is not intended to be the first opioid drug used in pediatric patients, but the data show that changing from another opioid drug to OxyContin is safe if done properly."
The FDA said Purdue must conduct a follow-up study to examine the rates of injury, overdose, accidents and medication errors in children taking the drug, with the report due in April 2019.
