Observational studyThe Korean journal of internal medicine2026
The medical impact of emergent banning of N-nitrosodimethylamine: contaminated antihypertensive drug.
Observational study in The Korean journal of internal medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
BACKGROUND/
aimsConcerns 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.
methodsNationwide 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.
resultsAmong 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.
conclusionUse 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.
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