US regulators have approved the use of Purdue Pharma’s powerful opioid painkiller OxyContin in children aged 11 years and older.
The US Food and Drug Administration has cleared the drug’s use in patients aged 11-16 years old experiencing pain severe enough to require daily, around-the-clock, long-term opioid treatment, when alternatives are inadequate.
The regulator had requested that Purdue carry out studies to assess the safety of OxyContin (oxycodone) in paediatric patients, which supported its use in the younger age group.
“Prior to this action, doctors had to rely on adult clinical data to shape their decision-making in treating pediatric patients,” said Sharon Hertz from the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research.
“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 paediatric patients,” she explained.
Addiction and abuse
OxyContin has been in the headlines for years because of abuse, addiction and death, but was re-formulated in 2010 to make it more difficult for addicts to crush the tablets for snorting or injection. And, as Hertz stressed, “children are not treated with opioids very often and usually it's only for a limited period of time with close supervision by healthcare professionals”.
However, as a condition of the drug’s paediatric approval, Purdue has been ordered to carry out a follow-up study to investigate injury, overdose, accidents and medication errors in children, results from which are expected in April 2019, the Wall Street Journal reports.
Johnson and Johnson’s fentanyl patch Duragesic and OxyContin are currently the only extended-release opioid products with FDA-approved labelling on paediatric use.