Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Dec 23;13(1):24.
doi: 10.3390/cancers13010024.

The Association between Ranitidine Use and Gastrointestinal Cancers

Affiliations

The Association between Ranitidine Use and Gastrointestinal Cancers

Gerald McGwin. Cancers (Basel). .

Abstract

N-nitrosodimethylamine (NDMA) is a carcinogen in experimental animals. It has been classified a probable human carcinogen and has been found in ranitidine. This study sought to evaluate the association between ranitidine use and cancer of the gastrointestinal system. Events reported to the FDA Adverse Events Reporting System that were associated with the use of proton pump inhibitors (PPIs) and H2 antagonists were selected. Proportionate reporting ratios (PRRs) and associated 95% confidence intervals (CIs) were calculated to compare the proportion of all reported adverse events that were for gastrointestinal system cancers among adverse event reports for ranitidine to adverse event reports for other H2 antagonists. The proportion of adverse events for any gastrointestinal system cancer relative to all other events was elevated for ranitidine compared to PPIs and other H2 antagonists (PRR 3.66, 95% CI 3.19-4.20). Elevated and significant PRRs were observed for pharyngeal (PRR 9.24), esophageal (PRR 3.56), stomach (PRR 1.48), colorectal (PRR 16.31), liver (PRR 2.64), and pancreatic (PRR 2.18) cancers. The PRRs for anal (PRR 4.62) and gallbladder (PRR 4.62) cancer were also elevated though not statistically significant. In conjunction with a large body of epidemiologic and human and animal basic science research, the study results support the hypothesis that NDMA-contaminated ranitidine increases the risk of cancer and supports the withdrawal of these medications from the market.

Keywords: N-nitrosodimethylamine (NDMA); gastrointestinal cancers; ranitidine.

PubMed Disclaimer

Conflict of interest statement

The author declares no conflict of interest.

References

    1. Timeline: Population Heartburn Medicine Zantac Pulled off Store Shelves. Reuters. October 2019. [(accessed on 21 December 2020)]; Available online: https://www.reuters.com/article/us-health-fda-heartburn-timeline-idUSKBN....
    1. FDA Updates and Press Announcements on NDMA in Zantac (Ranitidine). U.S. Food & Drug Administration. April 2020. [(accessed on 21 December 2020)]; Available online: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-p....
    1. Control of Nitrosamine Impurities in Human Drugs: Guidance for Industry. U.S. Food & Drug Administration. September 2020. [(accessed on 21 December 2020)]; Available online: https://www.fda.gov/media/141720/download.
    1. Concise International Chemical Assessment Document 38. World Health Organization. [(accessed on 21 December 2020)];2002 Available online: https://www.who.int/ipcs/publications/cicad/en/cicad38.pdf?ua=1.
    1. Technical Fact Sheet—N-Nitroso-Dimethylamine (NDMA). United States Environmental Protection Agency. November 2017. [(accessed on 21 December 2020)]; Available online: https://www.epa.gov/sites/production/files/2017-10/documents/ndma_fact_s....

LinkOut - more resources