This article is more than 5 years old. Information may no longer be current.
FDA approves OxyContin for use in adolescents
Click Here to Manage Email Alerts
The FDA has approved the use of OxyContin for pain management in adolescents aged 11 to 16 years, according to a recent release from the Center for Drug Evaluation and Research.
The new approval is intended for children needing long-term pain management, such as cancer and extensive trauma or surgeries that require round-the-clock care.
“In pediatric patients who require opioid treatment to manage pain, extended-release opioids may be a useful alternative because they are taken only once or twice per day rather than every 4 to 6 hours,” Sharon Hertz, MD, director of division of anesthesia, analgesia and addiction products, office of new drugs, center for drug evaluation and research, FDA, wrote in an interview published on the FDA’s website. “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 from pain. So from that perspective, it’s very useful.”
The FDA’s decision came after the Center for Drug Evaluation and Research (CDER) requested Purdue Pharma, the manufacturers of OxyContin (oxycodone), to evaluate the drug in pediatric patients.
According to the CDER, children prescribed OxyContin face the same warnings and precautions as adults who are prescribed the drug, adding that the decision to start and stop the medication should be discussed thoroughly between the health care team, parents and patient.
Hertz noted that OxyContin should only be prescribed to pediatric patients who have previously been prescribed, and tolerated, at least 20 mg/day of oxycodone.
“Prior to this action, doctors had had to rely on adult clinical data to shape their decision-making in treating pediatric patients. This program is 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,” Hertz concluded.
Reference:
Hertz S. CDER conversation: Pediatric pain management options. Available at: http://www.fda.gov/Drugs/NewsEvents/ucm456973.htm. Accessed August 17, 2015.