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No association between chronic use of ranitidine, compared with omeprazole or famotidine, and gastrointestinal malignancies
Author(s) -
Kim Yeseong D.,
Wang Jiasheng,
Shibli Fahmi,
Poels Kamrine E.,
Ganocy Stephen J.,
Fass Ronnie
Publication year - 2021
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.16464
Subject(s) - medicine , ranitidine , famotidine , gastroenterology , omeprazole , odds ratio , confidence interval
Summary Background In 2019, the United States Food and Drug Administration detected above‐regulation levels of the human carcinogen N‐nitrosodimethylamine (NDMA) in ranitidine, resulting in a complete removal of the medication from the market. NDMA is known to cause gastrointestinal malignancies in animal models. Aim To determine if patients who were receiving ranitidine have a higher risk of developing cancers of the digestive tract compared to patients taking other anti‐reflux medications. Methods Using the nationwide database IBM Explorys, patients taking ranitidine were compared to patients on either famotidine or omeprazole. Incidence data of new malignancies of the oesophagus, stomach, liver, pancreas, and colon/rectum were obtained in 1‐year intervals for up to 10 years. Two multivariable logistic regression models were used to calculate odds ratios (ORs), one adjusting for common risk factors for each cancer studied, and the other for demographic factors. Results Patients on ranitidine who were compared to patients on famotidine had ORs of 0.51(95% CI 0.43‐0.60), 0.43(95% CI 0.36‐0.51), 0.39(95% CI 0.36‐0.41), 0.54(95% CI 0.49‐0.62), and 0.46(95% CI 0.43‐0.49) of developing oesophageal, gastric, hepatocellular, pancreatic, and colorectal cancers, respectively ( P < 0.001). Patients on ranitidine compared to omeprazole had ORs of 0.62(95% CI 0.52‐0.72), 0.58(95% CI 0.49‐0.68), 0.81 (95% CI 0.76‐0.86), 0.68(95% CI 0.60‐0.76), and 0.66(95% CI 0.62‐0.70) of developing oesophageal, gastric, hepatocellular, pancreatic, and colorectal cancers respectively ( P < 0.001). Conclusions Use of ranitidine was not associated with an increased odds of developing gastrointestinal malignancies compared to omeprazole or famotidine use.