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The medical impact of emergent banning of N-nitrosodimethylamine: contaminated antihypertensive drug

Juhee Ahn, Sungho Won, Jong Heon Park, Hae‐Young Lee

The Korean Journal of Internal Medicine | Jul 1, 2026

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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.

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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.

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Juhee Ahn

first | Seoul National University

Sungho Won

middle | Seoul National University | ORCID 0000-0001-5751-5089

Jong Heon Park

middle | National Health Insurance Service | ORCID 0000-0002-4749-5878

Hae‐Young Lee

last | Seoul National University | ORCID 0000-0002-9521-4102

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@article{Ahn2026medical,
  title = {The medical impact of emergent banning of N-nitrosodimethylamine: contaminated antihypertensive drug},
  author = {Juhee Ahn and Sungho Won and Jong Heon Park and Hae‐Young Lee},
  journal = {The Korean Journal of Internal Medicine},
  year = {2026},
  doi = {10.3904/kjim.2026.023},
  url = {https://doi.org/10.3904/kjim.2026.023}
}

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