Reporting on Adverse Clinical Events

Abstract

A retrospective review of reports from the Food and Drug Administration Adverse Event Reporting System database was performed to evaluate the potential associations between the syndrome of inappropriate antidiuretic hormone secretion (SIADH) and various proton pump inhibitors (PPIs). Reports were extracted from the database from January 2004 to March 2020. The study identified a total of 273 reports of PPI-associated SIADH. The majority of cases were in elderly patients (71.1%). Women were more affected than men (48.7% vs. 41.8%). The highest reporting odds ratio (ROR) were reported with rabeprazole (ROR: 13.3, 95% CI = 7.2-24.9). The median time to SIADH onset was 22 (interquartile range: 6-692) days after PPI administration. PPI-associated SIADH was associated with a 2.95% fatality rate and a 79.7% hospitalization rate. The highest hospitalization death rate occurred in esomeprazole reports (91.2%). Based on the results of this retrospective review of reports received by the FDA database, the authors suggested that monitoring for SIADH in PPI users within the first months. IN addition, they suggested that larger epidemiological studies are warranted. Proton Pump Inhibitors [PPIs] Wang M et al (Jian Gong: Research Group of Jian Gong on Pharmacoepidemiology and Clinical Drug Evaluation, School of Life Science and Biopharmaceutics, Shenyang Pharmaceutical University, P.O. Box 88, No. 103 Wenhua Road, Shenyang 110016, P.R. China; e-mail: gongjian_1979@163.com) Syndrome of inappropriate antidiuretic hormone secretion is associated with different proton pump inhibitor use: a pharmacovigilance study. BMC Nephrol 23:191 (May) 2022