Adverse Event Reports for Nafamostat Mesylate and Sodium Citrate from WHO-VigiAccess

1,572 reports for nafamostat mesylate and 485 for sodium citrate were mined from the WHO-VigiAccess database up to December 2024. Mengting Xu authored this analysis, which uses disproportionality methods like ROR and PRR to identify safety signals. The study highlights severe immune-related AEs for nafamostat and metabolic complications for sodium citrate.

Use Cases

• Compare adverse event profiles between two anticoagulants based on reported system organ classes.
• Identify disproportionality signals for severe reactions like thrombosis in devices or anaphylactoid shock based on ROR values.
• Analyze demographic and geographic distribution patterns of adverse events mentioned in the results.
• Investigate adverse events not listed in drug instructions, such as citrate toxicity or spinal muscular atrophy.

Strengths

• Includes 1,572 adverse event reports for nafamostat mesylate and 485 for sodium citrate.
• Applies multiple statistical signal detection methods (ROR, PRR, BCPNN, EBGM).
• Reports specific disproportionality signals with high ROR values, such as 264.71 for thrombosis in devices.
• Uses standardized MedDRA coding for adverse event classification.

Limitations

• Row count for the underlying data is unknown, which may limit suitability assessment.
• Column-level documentation is absent; field semantics must be inferred after download.
• Data may reflect reporting bias inherent to spontaneous reporting systems like VigiAccess.

Provenance

Source

World Health Organization Adverse Drug Reaction Reporting Database (WHO-VigiAccess).

Collection Method

Data mining and statistical analysis using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM).

Time Range

Reports collected until 29 December 2024.

Freshness

Data collected until 29 December 2024; dataset last updated 2026-05-20.

Geography

Global reporting data.