The Medical Impact of Emergent Banning of N-nitrosodimethylamine (NDMA)- contaminated Antihypertensive Drug: A nationwide longitudinal cohort study: Oncology – Prostate Cancer

Disease Prevention Daily

2023 NOV 20 (NewsRx) -- By a News Reporter-Staff News Editor at Disease Prevention Daily -- According to news reporting based on a preprint abstract, our journalists obtained the following quote sourced from medrxiv.org:

“OBJECTIVE: To study the association of NDMA-contaminated generic valsartan with cancer incidence. DESIGN: Nationwide longitudinal observational cohort study. SETTING: Claims data from the National Health Insurance Service of South Korea was analyzed using 1:1:1 pairwise propensity score matching (PSM) of NDMA-uncontaminated original, NDMA-contaminated generic, and initially-suspended-but-finally confirmed as NDMA-uncontaminated generic valsartan user-groups. Time-dependent Cox models and dose-response evaluation were used to evaluate carcinogenicity. PARTICIPANTS: A total of 3,231,212 participants with satisfactory minimal adherence, followed up from January 1, 2013 until December 31, 2020. INTERVENTIONS: At least one tablet of valsartan. MAIN OUTCOME MEASURES: The primary outcome was primary cancer incidence and secondary outcome was 12 prevalent organ-specific cancer incidences. All-cause and cardiovascular mortality risks were estimated before and after valsartan withdrawal.

“RESULTS: Among participants (mean [standard deviation] age 59.5 [13.1] years; male, 53.5%), new users had adjusted hazard ratios and 95% confidence intervals (CI) of 1.069 (1.054 to 1.085) and 1.142 (1.100 to 1.186) for any cancer in the NDMA-exposed period (versus NDMA-unexposed) before and after 1:1:1 PSM, respectively. Regardless of PSM, lung and prostate cancer risks increased significantly during the NDMA-exposed period whereas, post-PSM, cancer risk did not increase in the eventually-NDMA-uncontaminated group, even in new users. All-cause and cardiovascular mortality did not differ significantly with NDMA exposure before and after emergent banning.

“CONCLUSIONS: NDMA-contaminated valsartan increased cancer risk, especially of lung and prostate cancers. All-cause and cardiovascular mortality did not evidently increase following banning.

“This supports emergent health-policy action against potentially carcinogenic drugs.”

This preprint has not been peer-reviewed.