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, Canada and Denmark (described below) to evaluate the impacts of the recalls due to nitrosamine impurities.
This analysis was conducted utilizing the Danish National Prescription Registry (DNPR) and includes four reports summarizing data obtained from the DNPR. The study period for Report 1 includes dispensing data from January 1, 2014, to May 1, 2020, and medical data from January 1, 2014, to December 31, 2018. The study period for Reports 2-4 includes dispensing data from May 1, 2012, to May 1, 2020, and medical data from January 1, 2014, to December 31, 2018:
- Report 1: We estimated the proportion of individual ARB-containing product use and the proportion of patients who switched from a primary ARB to another individual ARB over time. We distributed this request to the DNPR on January 27, 2022.
- Report 2: We estimated the incident utilization for all, branded, recalled, unclassified valsartan products, valsartan products with nitrosamine impurities or without nitrosamine impurities, and recalled ARBs over time. We distributed this request to the DNPR on July 29, 2022.
- Report 3: We estimated the prevalent utilization for all, branded, impurity identified, no impurity identified, recalled, and unclassified valsartan and recalled Angiotensin Receptor Blockers (ARBs) over time. We distributed this request to the DNPR on July 29, 2022.
- Report 4: We estimated the proportion of switching between categories of branded valsartan products and valsartan products with nitrosamine impurities or without nitrosamine impurities among prevalent users of branded valsartan products and valsartan products with nitrosamine impurities or without nitrosamine impurities. Switching is defined as the detection of a valsartan dispensing of another category within the exposure valsartan episode. We distributed this request to the DNPR on July 29, 2022.
Analyses were also conducted in the Sentinel Distributed Database (SDD), Canadian Network for Observational Drug Effect Studies (CNODES), and Clinical Practice Research Datalink (CPRD). A list of the results by country can be found in the Additional Information tab.