| The medical impact of emergent banning of N-nitrosodimethylamine: contaminated antihypertensive drug |
Juhee Ahn1,2,3, Sungho Won2,3,4,5, Jong-Heon Park6,7, and Hae-Young Lee8,9
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1Division of Data Science, College of Intelligent Software Convergence, University of Suwon, Suwon, Korea
2Department of Public Health Sciences, Seoul National University, Seoul, Korea
3Institute of Health and Environment, Seoul National University, Seoul, Korea
4RexSoft Inc., Seoul, Korea
5Interdisciplinary Program for Bioinformatics, College of Natural Sciences, Seoul National University, Seoul, Korea
6National Health Insurance Service, Wonju, Korea
7Department of Benefits Strategy, National Health Insurance Service, Wonju, Korea
8Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea
9Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea |
Corresponding Author:
Hae-Young Lee , Tel: +82-2-2072-0698, Fax: +82-2-3674-0805, Email: hylee612@snu.ac.kr
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Received: January 14, 2026; Revised: March 1, 2026; Accepted: March 10, 2026. |
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| Abstract |
Background/Aims: Concerns exist regarding the potential carcinogenic effect of N-nitrosodimethylamine (NDMA) as a contaminant of the antihypertensive medication, valsartan. This study evaluated the association of NDMA-contaminated valsartan with cancer incidence.
Methods: Nationwide longitudinal observational cohort of 3,231,212 participants from the National Health Insurance Service of South Korea consisted and was followed up more than 7 years. We performed 1:1:1 pairwise propensity score matching (PSM) of NDMA-uncontaminated, NDMA-contaminated, and initially-suspended-but-finally confirmed as NDMA-uncontaminated valsartan user-groups. The primary outcome was any primary cancer incidence. The secondary outcome was the incidences of 12 organ-specific cancers. The risks of all-cause and cardiovascular deaths were estimated before and after the withdrawal of valsartan.
Results: Among participants (59.5 ± 13.1 yr; male, 53.5%), valsartan new users had adjusted hazard ratios and 95% confidence intervals of 1.069 (1.054–1.085) and 1.172 (1.128–1.216) for any cancer in the NDMA-exposed period (versus NDMA-unexposed) before and after PSM, respectively. Regardless of PSM, prostate cancer risk increased significantly. All-cause and cardiovascular mortality did not differ significantly with NDMA exposure before and after emergent banning.
Conclusions: Use of valsartan products contaminated with NDMA was associated with a modestly increased risk of overall cancer compared with uncontaminated products, a finding that requires confirmation in further studies. |
| Keywords:
Valsartan ; N-nitrosodimethylamine ; Death ; Cancer |
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