Proton pump inhibitors and increased risk of renal neoplasm notification: exploration and analysis of FAERS-based adverse event data

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Expert opinion Medicament Saf. December 17, 2021. doi: 10.1080 / 14740338.202.2020245. Online ahead of print.


BACKGROUND: Long-term use of proton pump inhibitors (PPIs) is associated with certain safety concerns. In this study, data mining was performed to uncover the potential association between renal neoplasms and PPIs.

DESIGN AND RESEARCH METHODS: Signals of PPI neoplasms were detected in the Food and Drug Administration Adverse Event Reporting System from 2014 to 2020 by examining the odds ratio. Adjusted odds ratios were analyzed by logistic regression.

RESULTS: Signals were detected for renal hemangioma, acquired or unspecified cystic kidney disease, and papillary and unspecified renal cell carcinoma, with intervals between onset of adverse reactions and medication 7.00 (3.33, 15.67) years, 5.00 (1.70, 10.25) years and 7.00 (4.72, 12.25) years respectively. Lansoprazole had the strongest signal. The adjusted odds ratios for PPI-associated renal carcinoma of cases with or without acquired cystic kidney disease or chronic kidney disease were 1.67. [95% confidence interval (CI) 1.46-1.91] and 1.62 (95% CI 1.41-1.87).

CONCLUSIONS: Exposure to PPIs was associated with an increased risk of renal neoplasms. Particular attention should be paid to the possibility of increased risk when administering PPI.

PMID: 34915780 | DOI: 10.1080 / 14740338.202.2020245

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