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 (described below), United Kingdom, Canada and Denmark to evaluate the impacts of the recalls due to nitrosamine impurities.
This analysis was conducted utilizing the Sentinel Distributed Database (SDD), and includes four reports summarizing data obtained from the SDD. The study period for Report 1 includes data from January 1, 2014, to May 31, 2021. The study period for Reports 2-4 include data from May 1, 2012, to November 30, 2021:
- 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 six Sentinel Data Partners (DPs) on December 22, 2021.
- Report 2: We estimated the incident utilization for all, branded, impurity identified, no impurity identified, recalled, and unclassified valsartan, and recalled ARBs over time. We distributed this request to six Sentinel DPs on July 28, 2022.
- Report 3: We estimated the prevalent utilization for all, branded, impurity identified, no impurity identified, recalled, and unclassified valsartan, and recalled ARBs. We distributed this request to six Sentinel DPs on July 28, 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 six Sentinel DPs on July 28, 2022.
Analyses were also conducted in the Canadian Network for Observational Drug Effect Studies (CNODES), Clinical Practice Research Datalink (CPRD), and Danish National Prescription Registry (DNPR). A list of the results by country can be found in the Additional Information tab.