• Willy Gomm, Christoph Röthlein, Katrin Schüssel, Gabriela Brückner, Helmut Schröder, Steffen Heß, Roland Frötschl, Karl Broich, and Britta Haenisch.
• German Center for Neurodegenerative Diseases (DZNE) e. V., Bonn; AOK Research Institute (WIdO), Berlin; Federal Institute for Drugs and Medical Devices (BfArM), Bonn; Center for Translational Medicine, University Hospital Bonn.
• Dtsch Arztebl Int. 2021 May 28; 118 (21): 357-362.

BackgroundN-Nitrosodimethylamine (NDMA), classified as a probable human carcinogen, has been found as a contaminant in the antihypertensive drug valsartan. Potentially carcinogenic effects associated with the consumption of NDMAcontaminated valsartan have not yet been analyzed in large-scale cohort studies. We therefore carried out the study reported here to explore the association between NDMA-contaminated valsartan and the risk of cancer.MethodsThis cohort study was based on longitudinal routine data obtained from a large German statutory health insurance provider serving approximately 25 million insurees. The cohort comprised patients who had filled a prescription for valsartan in the period 2012-2017. The endpoint was an incident diagnosis of cancer. Hazard ratios (HR) for cancer in general and for certain specific types of cancer were calculated by means of Cox regression models with time-dependent variables and adjustment for potential confounders.ResultsA total of 780 871 persons who had filled a prescription for valsartan between 2012 and 2017 were included in the study. There was no association between exposure to NDMA-contaminated valsartan and the overall risk of cancer. A statistically significant association was found, however, between exposure to NDMA-contaminated valsartan and hepatic cancer (adjusted HR 1.16; 95% confidence interval [1.03; 1.31]).ConclusionThese findings suggest that the consumption of NDMA-contaminated valsartan is associated with a slightly increased risk of hepatic cancer; no association was found with the risk of cancer overall. Close observation of the potential long-term effects of NDMA-contaminated valsartan seems advisable.

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