FDA to Review Vicodin and other Hydrocodone Painkillers

FDA to Review Vicodin and other Hydrocodone Painkillers

The Food and Drug Administration (FDA) in October is set to consider the reclassification of Vicodin and other hydrocodone-based painkillers from Schedule III to Schedule II substances.

It is about time.

Hydrocodone, just like oxycodone, is a pure opioid agonist (that is, it is a pure narcotic) and is classified as a Schedule II medication.  But when combined with acetaminophen or a non-steroidal anti-inflammatory drug (NSAID) to make Vicodin and other pain relievers, it is considered a Schedule III drug.

Reclassification of hydrocodone combinations to Schedule II will put more barriers in place to reduce their availability. To obtain these drugs a person will need a physical prescription from their physician (no more “calling in” of the medication).  By employing this more restrictive classification, it will cause “pause” by a physician prior to writing, and will necessitate closer tracking of the prescriptions written for hydrocodone. Currently prescription drug monitoring programs (PDMP’s) are in place in 40 states.

Why is this necessary?  Well, for starters, the United States utilizes approximately 99 percent of the world’s supply of hydrocodone. We also utilize 90 percent of the world’s supply of narcotics.

I personally do not believe that is because we have more pain in this country.  I believe it is because pharmaceutical companies have been very successful in their marketing, while operating in an academic void — namely that of a sound education for physicians about pain and its treatment.

Don’t misunderstand me. There is nothing wrong with marketing narcotics or any other legal product. What is wrong is that the majority of physicians in the United States have not learned their pharmacology from a medical school professor, but rather from a pharmaceutical representative (this is true for many medications, not just narcotics).  This, compounded with the minuscule importance of “pain” in the medical curriculum, has led to an explosion of inappropriate prescribing. This has caused harm. While certainly not the intention of the vast majority of physicians, we are now in a crisis of misappropriate use of these very good medications.

Hats off to the FDA if they prove to have the fortitude (against very strong lobby groups) to reclassify hydrocodone combinations as Schedule II medications.

Dan Bennett, MD, DABPM

There is 1 comment for this article
  1. Bob Sherman at 6:35 am

    By doing this many locations would not have any pain relief thats not OTC. Currently many places have quit carrying and quit shipping C2’s to pharmacies. C3’s are all thats left. Take away percoset and, vicoden and tylox and whats C3? Excedrin? Do you want a prescription for that.