Urinary Tract Infections and Urosepsis in Multiple Sclerosis: Insights from FDA Pharmacovigilance Data
Alexandra Balshi1, Madelyn Esser2, Tamara Kaplan3
1Harvard Medical School, 2Boston College, 3Brigham and Women's Hospital
Objective:
To evaluate the risks of urinary tract infections (UTI) and urosepsis across multiple sclerosis (MS) disease-modifying therapies (DMTs) using publicly available pharmacovigilance data.
Background:
UTIs and resulting urosepsis are a common cause of morbidity and mortality among people with MS. These risks are amplified by neurogenic bladder dysfunction and immunomodulation from MS DMTs. However, the relative contribution of specific DMTs to UTI and urosepsis risk remains underexplored.
Design/Methods:
The FDA Adverse Event Reporting System (FAERS) was analyzed using the OpenVigil 2.1 platform to identify disproportionally high reporting of UTI and urosepsis among DMTs compared with other FAERS medications. Reports from October 2003 to December 2024 were included and stratified by sex and age (≤50 and ≥51 years). Disproportionality was assessed using reporting odds ratios (RORs), 95% confidence intervals, and chi-square testing with Yates correction. Only reports where a DMT was the primary suspect drug were included.
Results:
Across DMTs, 12,997 reports of UTI and 651 of urosepsis were identified in people with MS. Ocrelizumab had the greatest association with UTI, and natalizumab, alemtuzumab, and interferon-beta-1a exhibited safety signals for both outcomes across all sex and age subgroups. Hospitalization occurred in nearly 7,000 cases, and more than 500 deaths were reported.
Conclusions:
This real-world pharmacovigilance analysis identifies disproportionate reporting of UTI and urosepsis across several MS DMTs, underscoring their contribution to morbidity and mortality. These associations likely reflect both therapy-related immunologic effects and disease-intrinsic factors, particularly neurogenic bladder dysfunction. These findings highlight the need for vigilant infection surveillance, proactive bladder management, and individualized risk assessment in MS care.
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