FDA approves the use of OxyContin for young patients

In a prior post, we highlighted the practice, as well as the dangers of off-label marketing. For those unfamiliar with the practice, off-label marketing (or use) is when doctors prescribe medications for uses that they were not intended for, or approved of by the U.S. Food and Drug Administration. Because of the long and arduous process of gaining approval through the FDA, off-label marketing and uses has become commonplace. A prime example of a successful off-label use is Viagra, which was initially intended as a drug to lower blood pressure, but is now the most famous erectile dysfunction drug in the world.

Another example of off-label use is OxyContin for juveniles. OyxContin is a version of oxycodone, which is a powerful, opiod-based painkiller. Because OxyContin is so powerful and highly addictive, the FDA had not previously approved it for use in young people under the age of 18.

However, the drug’s manufacturer, Purdue Pharma LP, conducted clinical trials and submitted data to FDA regarding its findings on OxyContin use in young people. Essentially, since the drug has been reformatted, it is less likely for it to be abused by being crushed or dissolved so that it may be taken through the nasal passages or intravenously. As such, the FDA has approved it for young people.

Moreover, the approval and the corresponding information supporting it, would fill a knowledge gap that would give practitioners the information they need to properly prescribe the drug. Despite the FDA’s approval, OxyContin should still not be prescribed to children without proper research and diagnosis. Failing to do so could put a young patient in serious danger.