In August of this year, the FDA approved the use of OxyContin (oxycodone) for pain management in certain pediatric patients, a move that has generated both support and powerful criticism from various quarters. Although the medication has been prescribed off-label for pediatric pain for many years, concern has been widespread that the FDA action will exacerbate the opioid abuse epidemic and that the decision was taken without the input of an independent advisory committee. On the other side of the argument, pediatric oncologists and other providers have pointed to the special pain management needs of their patients that OxyContin effectively addresses. An article in last week’s New York Times summarizes the major points of the debate so far.
Under the provisions of the Best Pharmaceuticals for Children Act (BPCA) of 2002, FDA issued a Pediatric Written Request to OxyContin manufacturer Perdue Pharma to evaluate the safety of the medication and its pharmacokinetic profile in pediatric patients likely to receive OxyContin from their doctors. According to information on the FDA website, the studies supported the addition of a pediatric indication to the OxyContin label for patients 11 to 16 years old, and provided the much needed data to healthcare providers. The new study data and resulting pediatric indication for OxyContin give doctors more specific information on how to safely manage pain in their pediatric patients following these types of surgery or traumas.
Read more about oxycodone abuse, here.
Read the New York Times article discussing the issue here.
Further discussion of the decision, from the FDA’s Center for Drug Evaluation and Research, may be read here.