N-Nitrosodimethylamine-contaminated ranitidine and risk of cancer in South Korea: a nationwide cohort study
Abstract
Objective: On September 2019, the United States Food and Drug Administration announced that some ranitidine products were contaminated with unacceptable levels of N-nitrosodimethylamine (NDMA). We aimed to determine whether the use of ranitidine that was potentially contaminated with NDMA, rather than another histamine H2-receptor antagonist (H2 blocker), increased the risk of overall cancer. Methods: We performed a Korean population-based nationwide cohort study with propensity score matching of 95,656 adults (unmatched) and 55,584 adults (matched) who initiated treatment with H2 blockers between January 2005 and December 2014, and were followed until December 2015. Incident overall cancer was the primary outcome and all-cause mortality was the secondary outcome. http://www.elifecycle.org Ranitidine and risk of cancer https://doi.org/10.54724/lc.2021.e1 2 / 17 Results: The unweighted cohort had 30,335 new users of ranitidine and 65,321 new users of other H2 blockers. The weighted cohort had 27,792 new users of ranitidine and 27,792 new users of other H2 blockers (median age, 55.0 years [interquartile range, 45-63]; 21,186 men [38.3%]). During follow-up (median of 6.8 years for ranitidine vs. 6.6 years for other H2 blockers), there were 2,840 new diagnoses of cancers and 1,758 deaths among users of other H2 blockers, and 2,113 new diagnoses of cancers and 1,933 deaths among users of ranitidine. The adjusted hazard ratio (aHR) for overall cancer in ranitidine users was 1.01…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 95,656 participants or records.
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