A paper written by Ravi J. Desai PharmD Candidate 2020 of PittPharmacy was recently published in JAMA Open.
The purpose of the article, Varenicline and Nicotine Replacement Use Associated With US Food and Drug Administration Drug Safety Communications, was to examine the impact of early FDA drug safety communications on drug utilization. These warnings are often released prematurely or in very early stages of study in response to public outcry or negative media attention. Thus, they may not always be accurate or truthful about risks associated with the medication in question.
Desai's study in particular looked at a very effective smoking cessation agent, varenicline, commonly known as Chantix. The study was done using prescribing data from Department of Veteran’s Affairs and Medicaid patients. Research found that there were marked decreases in varenicline utilization in close correlation with the release of FDA and other media/agency warnings. This was then compared to an observed increase in the alternative treatment of traditional nicotine replacement therapy, which is known to be less effective than varenicline for helping people quit smoking. The data was extrapolated to estimate a possible number of deaths that were not prevented due to the decreased use of varenicline.
