Drug-related proteinuria: a vigilance analysis based on the FAERS database

Area of Science:

• Pharmacovigilance
• Nephrology
• Drug Safety

Background:

• Proteinuria is a significant adverse drug reaction (ADR) linked to various pharmaceuticals.
• Investigating drug-induced proteinuria is crucial for patient safety and effective drug development.

Purpose of the Study:

• To identify and assess medications associated with proteinuria using the FDA Adverse Event Reporting System (FAERS) database.
• To analyze drug classes and onset times for proteinuria to inform clinical monitoring strategies.

Main Methods:

• Analysis of the FAERS database (2004-2024) using the keyword "proteinuria".
• Utilized Ratio-of-Reported-Ratio (ROR) and Proportional-Reported-Ratio (PRR) for statistical association.
• Multivariate logistic regression identified significant drug-proteinuria links.

Main Results:

• 16,355 proteinuria-related adverse event reports were identified.
• Voclosporin (ROR: 63.57) and Lenvatinib (ROR: 41.01) showed the strongest association.
• Anticancer, immunosuppressant, and antiviral drug classes were most implicated; onset times varied significantly by drug class.

Conclusions:

• Specific drugs like voclosporin and lenvatinib pose a high risk for drug-induced proteinuria.
• Renal monitoring should be tailored based on drug class and anticipated onset time.
• Early nephrotoxicity assessment is vital for drug screening and optimization.