The U.S. Food and Drug Administration has finally approved OxyContin(oxycodone) for children on Thursday, August 13.
The use of OxyContin among children is not something new. It has already been prescribed by doctors for patients whose pain level remains the same or has become worse despite other medications. The problem is since there's no standard or guideline specifically meant for children's use, doctors have to rely on FDA-approved adult regulations for the drug. With this approval, therefore, doctors will be more guided as to how much should be provided to children.
The FDA largely based its approval on the successful clinical trial conducted by Purdue Pharma LP, which has proven that the medication, under strict supervision and accurate dosage, can be considered both safe and effective to children between the ages of 11 and 16.
However, with the approval comes the biggest concern among doctors and parents alike: addiction. OxyContin, in particular, and painkillers in general, are some of the most abused medications in the United States, causing a sharp increase of related deaths and overdose.
OxyContin contains oxycodone, which is a semi-synthetic type of opiod. It binds with certain receptors in the central nervous system, altering a person's perception and sensation of pain.
Over the years, the formulations of OxyContin have been changed in order to curb abuse. For example, the newer types are more difficult to break down or dissolve to prevent IV administration. (As a slow-releasing tablet, the effect builds up over time. Taking it through the veins will speed up the effect.)
To significantly reduce the possible abuse among children, the FDA issues terms and conditions. Children should be in a very severe pain the only option left is OxyContin. Further, the patient should already be in 20 mg oxycodone or more per day before OxyContin can be provided. The drug's use should be immediately stopped once the patient no longer needs it. Parents and caregivers are also strongly advised to store and dispose the drugs properly.
Purdue would also have to submit reports to the FDA including data on drug use among the targeted patients. Every 3 years, the company has to report any adverse side effects or events resulting from children's intake.