The U.S. Food and Drug Administration has approved the use of the opioid painkiller OxyContin for children and adolescents aged 11 to 16 who have chronic and around-the-clock pain that has not been helped by other methods of pain relief. OxyContin is a controlled-release formulation of the opioid drug oxycodone.
OxyContin has been used by adults who have moderate to severe chronic pain, especially pain that occurs around the clock, for about 20 years. However, OxyContin has had to be reformulated over the years because it has become a major prescription drug of abuse in the United States. Drug abusers discovered that the first formulation of the drug could be ground up and snorted or injected for a powerful high. The tablets were reformulated to make this more difficult.
"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," said Sharon Hertz, MD, an official in the FDA's Center for Drug Evaluation and Research (CDER).
The warnings and precautions for the use of OxyContin in patients in this age range are the same as those for adults, the FDA said on its website. However, unlike with adults, doctors are to prescribe OxyContin only for children who already been treated with a minimum dose of 20 milligrams of a non-controlled version of oxycodone. This requirement is to ensure that the patient can tolerate the drug and the dosage before the controlled-release form is used.
Purdue Pharma LP, the maker of OxyContin, will also conduct postmarketing studies of the drug. This means that the company will collect data to determine if the drug is being safely used in this age group.
The other long-acting opioid option for children in chronic pain is a patch containing the pain reliever fentanyl.
