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FDA Requires Stronger Warning Labels for Benzodiazepines

October 05, 2020

cawleyBenzodiazepines (BZs) are one of the most heavily prescribed medications. Since chlordiazepoxide was first approved in 1960, statistics on their use are staggering. From 1996 to 2013 the percentage of adults who filled a BZs prescription per year increased 30%. 1 In 2008, approximately 5.2% of adults in the Unites States age 18-80 used BZs. 2 The overdose death rate more than quadrupled between 1999 to 2010.  In 2019, an estimated 92 million BZs prescriptions were dispensed from United States pharmacies. 3

As pharmacists we can relate to these statistics. We also know that they should only be prescribed for a short period of time but how often do we see refill after refill for the same patient. Unfortunately, many of us do not have the time, the medical history of the patient or cooperation of the prescriber to limit or stop the continued prescribing of these agents.  The FDA has issues new boxed warnings for the use of BZs including changes to the prescribing information and patient medication guides. 3

Although I do applaud the FDA for making this move, it has been a long time coming. These changes should have been implemented at least a decade ago based upon the alarming statistics on the use and misuse of BZs. This class of drugs have been overly prescribed for decades. A recent comment from an Emergency Room physician stated, "the FDA is hoping that by adding verbiage to the current warning that providers will be extra careful in not only prescribing these medications, but also to be mindful of the duration." 3

I agree this is a positive step forward, however, I do not believe many prescribers will change their BZs prescribing habits. Many prescribers will be unaware of the new warnings. I would recommend that pharmacists educate prescribers on the new warnings as they receive BZs prescriptions. Maybe through your interventions you may be able to prevent the next addicted patient or saving a life in preventing the next overdose.  

Michael J. Cawley, PharmD, RRT, CPFT, FCCM, has more than 25 years of experience practicing in the areas of medical, surgical, trauma, and burn intensive care as both a critical care clinical pharmacist and registered respiratory therapist.

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  1. Marcus A. Bachhuber, Sean Hennessy, Chinazo O. Cunningham, and Joanna L. Starrels.  Increasing Benzodiazepine Prescriptions and Overdose Mortality in the United States, 1996–2013. American Journal of Public Health: April 2016, Vol. 106, No. 4, pp. 686-688. doi: 10.2105/AJPH.2016.303061.
  2. Olfson M, King M, Schoenbaum M. Benzodiazepine use in the United States. JAMA Psychiatry. 2015;72(2):136-142. doi:10.1001/jamapsychiatry.2014.1763
  3. USA Today. FDA requires stronger warning label for Xanax, Valium and other similar benzodiazepine drugs. Accessed September 25,2020.

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