Despite theoretical concerns that impurities with N-nitrosodimethylamine (NMDA) identified in samples of ranitidine (trade name: Zantac) could increase the risk of cancer, a recent study (N Mohyuddin et al. DDW 2020; Abstract#152. RISK OF CANCER WITH USE OF RANITIDINE: RESULTS OF A COHORT STUDY OF 65 MILLION US ADULTS) did not find any evidence of this.

Methods: The authors utilized the Explorys database (IBM, New York) which is a source of longitudinal real world deidentified data collected from electronic medical records from over 40 health systems nationwide (65 million) from 1999-2019.

Key findings:

• 1.62 million users of ranitidine were identified, 3.37 million users of famotidine, and 59.63 million individuals who did not use either H2 blocker.
• Users of ranitidine and famotidine when compared to the general population, and users of famotidine when compared to ranitidine, were older (p<0.001), smokers (p<0.001), obese (p<0.001), had liver cirrhosis (p<0.001), a history of alcohol use (p<0.001), and a family history of cancer (p<0.001).
• Ranitidine users had a numerically lower risk for GI cancers (liver, stomach, esophageal, colorectal, and pancreatic cancers) compared to famotidine. Among subjects without risk factors including smoking, obesity, alcohol use, family history, cirrhosis and GERD, the risk of all cancers (excluding non-melanoma skin cancers) was identical for ranitidine and famotidine (OR=1, CI=1.01-1.02, p=0.001).

My take: This large database did NOT identify an increased risk of malignancy with ranitidine over a 20 year span.  Despite this, I don’t expect that the FDA will reverse its recall.

Related blog posts:

• What to Tell Patients About Ranitidine from AGA
• Preliminary Recommendations from NASPGHAN on Ranitidine Warnings

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