Proposed Hydrocodone Combination Products Reclassification

Fda (Photo credit: Wikipedia)

FDA to submit formal recommendation to HHS regarding reclassifying hydrocodone

This heading seems straightforward. Don’t you think? It might surprise you to learn more about the steps involved in reclassifying a drug. On October 24, 2013, Janet Woodcock, M.D., Director of the Center for Drug Evaluation and Research issued a formal statement on the U.S. Food and Drug Administration (FDA)’s website regarding reclassifying hydrocodone. Dr. Woodcock wrote:

In 2009, the U.S. Drug Enforcement Administration (DEA) asked the U.S. Department of Health and Human Services (HHS) for a recommendation regarding whether to change the schedule for hydrocodone combination products, such as Vicodin. The proposed change was from Schedule III to Schedule II, which would increase the controls on these products. Due to the unique history of this issue and the tremendous amount of public interest, we are announcing the agency’s intent to recommend to HHS that hydrocodone combination products should be reclassified to a different and more restrictive schedule.

This proposed reclassification is expected affect millions of citizens, pharmacists and prescribing medical professionals. It is an involved process; the reclassification steps will go something like this:

  • In December the FDA plans to submit a formal reclassification recommendation to the U.S. Department of Health & Human Services (HHS) asking that hydrocodone combination products be changed to Schedule II 
  • The FDA is hopeful that the National Institute on Drug Abuse (NIDA) will agree with the recommendation
  • The final decision will be made by the DEA

Other examples of Schedule II drugs are Adderall, Ritalin, OxyContin, morphine, opium and codeine. Pure hydrocodone is a Schedule II drug; however, when combined with Acetaminophen it is currently a Schedule III drug. It is these hydrocodone combination products that are being reviewed for reclassification.

Reviewing the statistics…again

You may remember it was just about one year ago that we published a post regarding CNN’s Chief Medical  Correspondent Dr. Sanjay Gupta’s special documentary “Deadly Dose.”   At the time we offered the following statistics:

  • Every 19 minutes someone dies from a drug overdose in the United States. 
  • This number includes those dying from both legal and illegal drugs; however, most are due to legal prescription drugs. 
  • Accidental overdoses from prescription drugs now exceed the combined total of deaths from heroin, crack and methamphetamines. 
  • Accidental deaths from overdoses resulting from legal prescription drugs now exceed deaths by car accidents. 
  • 80% of the world’s pain pills are consumed in the United States, according to 2011 congressional testimony from the American Society of Interventional Pain Physicians. 

Adding to these, CBS News reports: “Deaths from prescription painkiller overdoses in women increased more than 400 percent since 1999, compared to 265 percent among men.

In 2010, 2 million people reported using prescription painkillers non-medically — which includes without a prescription or taking them for the feeling they cause — for the first time within the last year.”

NBC’s Dr. Nancy Snyderman reports on the proposed reclassification


If you are having trouble viewing the video, you can see it here.

It is important to remember when a person has been abusing several dependence-causing drugs; the detoxification process can become complicated. At Cottonwood Tucson, our medical providers have years of experience in safely managing complex detoxification and are able to help our patients to negotiate the withdrawal process safely and with a minimum of discomfort. Once this is done, our treatment team will work with the patient to explore root causes of physical and emotional pain and help them find more adaptive ways of managing distress.

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