Pharmacovigilance study of the association between proton pump inhibitors and musculoskeletal and connective tissue disorders based on the FAERS database
Abstract
Background: To investigate adverse event (AE) signals associated with six proton pump inhibitors (PPIs), enhance drug labeling information, and provide guidance for their safe clinical use. Methods: Adverse reaction data for musculoskeletal and connective tissue disorders related to six PPI formulations—omeprazole, pantoprazole, lansoprazole, esomeprazole, rabeprazole, and dexlansoprazole—from Q1 2004 to Q4 2023 were collected from the FDA Adverse Event Reporting System (FAERS). Signal detection was performed using the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM). Data processing and statistical analysis were conducted using R Studio 4.40. Results: A total of 6,635, 3,853, 1,792, 15,731, 483, and 534 adverse events were identified for the six PPIs, respectively. The four algorithms (ROR, PRR, BCPNN, and EBGM) generated 17, 19, 8, 27, 5, and 2 positive signals. Notably, signals for renal osteodystrophy and osteoporosis were more frequent, with stronger signals for lumbar flexion syndrome and renal osteodystrophy. Conclusion: Patients with chronic kidney disease, a high risk of osteoporosis and fractures, or those using statins should select PPIs with a lower risk of adverse musculoskeletal and connective tissue reactions to minimize these adverse effects and ensure standardized clinical use of PPIs.
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