Comparative safety profiling of sodium zirconate cyclosilicate and patiromer using real-world FAERS data: A...

This study aimed to detect and contrast the adverse drug event (ADE) signals associated with sodium zirconate cyclosilicate (SZC) and Patiromer by leveraging the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS), thereby informing safer clinical decision-making and optimizing therapeutic selection in hyperkalemic patients. We utilized multiple signal detection algorithms, including the reporting odds ratio (ROR), the UK Medicines and Healthcare products Regulatory Agency method, Bayesian confidence propagation neural networks, and the multi-item gamma Poisson shrinker, to extract adverse reaction signals for SZC (from Q2 2018 to Q3 2024) and Patiromer (from Q4 2015 to Q3 2024) from the FAERS database. Our analysis encompassed 8586,052 reports for SZC and 11,937,823 for Patiromer, with 1559 and 12,715 reports, respectively, flagged as primary suspect drugs. The most reports originated from the United States (SZC: 74.21%, Patiromer: 96.02%). The primary reporters were consumers for SZC (34.38%), physicians (31.50%), and consumers for Patiromer (68.16%). Both medications were predominantly prescribed for hyperkalemia management (SZC: 74.93%, Patiromer: 57.84%). We detected 51 significant signals for SZC and 122 for Patiromer. Key signals for SZC involved mortality, increased blood potassium, constipation, hypokalemia, and edema. For Patiromer, prominent signals comprised constipation, death, product leakage issues, and diarrhea. SZC primarily influenced systemic disorders and gastrointestinal complications, whereas Patiromer was associated with gastrointestinal conditions, systemic effects, and reactions at the administration site. Healthcare providers should consider adverse drug events not documented in the prescribing information for SZC (such as hypernatremia, mortality, and congestive heart failure) and Patiromer (such as Individuals undergoing dialysis or using pacemakers might encounter complications like arteriovenous fistula disorders and pacemaker modifications). Positive signals for Patiromer also indicate concerns regarding product solubility, color, taste, and texture, potentially impacting patient compliance. Due to the high frequency of death reports associated with both drugs (SZC: 573, Patiromer: 1656), clinicians should exercise heightened vigilance.