Doctors are now allowed to prescribe oxycodone — trade name OxyContin — for children in severe pain.
Dr. Sharon Hertz, FDA director of new anesthesia, analgesia and addiction products, made remarks published on FDA’s website that 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.”
The FDA asked the manufacturer of OxyContin, Purdue Pharmaceuticals, to conduct the studies, Hertz said. The FDA can use its authority to request studies on pediatric uses of prescription drugs.
“To manage pain in pediatric patients, physicians often have to rely on their own experience to interpret and translate adult data into dosing information for pediatric patients,” Hertz said.
Public information on the studies, available at ClinicalTrials.gov, said that OxyContin was tested for safety and how the drug acted in the body. Children, ages six to 16, were enrolled in the studies over a four-year period. Unspecified “severe adverse events” were reported among 17.4 percent of children enrolled in the study.
OxyContin is an extended-release version of oxycodone, an opioid that acts on the brain like heroin and is intended to treat moderate-to-severe pain over a long period of time. Children in severe pain may be prescribed the drug. Hertz cites surgery and trauma as the type of serious health problems that may warrant prescribing the medication.
The advantage of OxyContin is its twice-daily dosing and parents don’t have to give medications as frequently. Doctors who prescribe shorter-acting pain medications now have another option for young patients.
Oxycodone and other opioids are extremely powerful and highly addictive. Even patients using the exactly as prescribed can become dependent. “When the decision is made to stop the medication, it should be done slowly and carefully to avoid withdrawal symptoms,” said Hertz.
The FDA says that doctors should prescribe OxyContin to children already on a faster-acting opioid drug for five days. The dose would be lower at 20 mg per day, twice daily than what adults take, said Hertz.
“We are always concerned about the safety of our children, particularly when they are ill and require medications and when they are in pain,” she said. “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.”
While Hertz recommends close supervision, parents and caregivers will give this drug to their kids at home.
The FDA says parents should lock up their drugs to prevent children from eating the drugs and teens from stealing them. Thousands of children are poisoned by swallowing drugs not meant for them.
Purdue remade OxyContin five years ago to make it harder for patients to crush the pills for a fast high, but the powerful narcotic can still be abused.
Roughly 15,000 people die from prescription drug overdoses in the U.S. each year, said the Centers for Disease Control and Prevention. Deaths from prescription pills are greater than from heroin and cocaine combined.
The official prescription label information says: “Safety and effectiveness of OXYCONTIN in pediatric patients below the age of 18 years have not been established.”
Purdue Pharma will conduct post-marketing studies to monitor the safety of the drug in children.
