No excess risk of gastrointestinal malignancies with ranitidine vs other reflux drugs

27 Jul 2021

Use of the histamine-2 receptor antagonist (H2RA) ranitidine does not appear to increase the likelihood of developing gastrointestinal malignancies as compared with omeprazole or famotidine, as shown in a study.

The study used data from the nationwide database IBM Explorys and included patients treated with ranitidine, famotidine, or omeprazole. Data on the incidence of new malignancies of the oesophagus, stomach, liver, pancreas, and colon/rectum were collected in 1-year intervals for up to 10 years.

Researchers applied two multivariable logistic regression models to estimate the risk of gastrointestinal malignancies. One model controlled for common risk factors for each cancer studied, while the other model adjusted for demographic factors.

According to results, ranitidine treatment did not contribute to an increase in the risk of malignancies. Compared with patients on famotidine, those on ranitidine did not show a higher likelihood of developing oesophageal (odds ratio [OR], 0.51, 95 percent confidence interval [CI], 0.43–0.60), gastric (OR, 0.43, 95 percent CI, 0.36–0.51), hepatocellular (OR, 0.39, 95 percent CI, 0.36–0.41), pancreatic (OR, 0.54, 95 percent CI, 0.49–0.62), and colorectal (OR, 0.46, 95 percent CI, 0.43–0.49) cancers (p<0.001).

The same was true when compared with patients on omeprazole. There were no increased risks of oesophageal (OR, 0.62, 95 percent CI, 0.52–0.72), gastric (OR, 0.58, 95 percent CI, 0.49–0.68), hepatocellular (OR, 0.81, 95 percent CI, 0.76–0.86), pancreatic (OR, 0.68, 95 percent CI, 0.60–0.76), and colorectal (OR, 0.66, 95 percent CI, 0.62–0.70) cancers seen with ranitidine (p<0.001).

In 2019, ranitidine was completely removed from the market as a result of the United States Food and Drug Administration detecting above-regulation levels of the human carcinogen N-nitrosodimethylamine, a compound that causes gastrointestinal malignancies in animals.

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