Details
In 2018, North American and European drug regulatory agencies notified the public about recalls of valsartan and certain other angiotensin II receptor blocker (ARB) products after discovering the presence of potential carcinogenic nitrosamine impurities, N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), in the products. Collaborating with international institutions, we examined valsartan and other angiotensin receptor blocker (ARB) utilization and switching patterns in the United States, United Kingdom (described below), Canada, and Denmark to evaluate the impacts of the recalls due to nitrosamine impurities.
This analysis was conducted utilizing the Clinical Practice Research Datalink (CPRD). We estimated the proportion of individual angiotensin receptor blocker (ARB)-containing product use and the proportion of patients who switched from a primary ARB to another individual ARB over time in the CPRD. The study period includes data from January 1, 2014, to August 25, 2020. We distributed this request to the CPRD on January 14, 2022.
Analyses were also conducted in the Sentinel Distributed Database (SDD), Canadian Network for Observational Drug Effect Studies (CNODES), and Danish National Prescription Registry (DNPR). A list of the results by country can be found in the Additional Information tab.