Cross-database intersection analysis found 54.6% of 2,021,522 unique SDRs exclusive to one database; only 0.1% appeared in all four . The authors state these differences reflect reporting-system characteristics, not true clinical differences, and that no sensitivity analysis of deduplication thresholds was performed .
Region-specific drug enrichment was not directly tested. VigiBase rivaroxaban reports were 55.3% US-origin , and 94.2% of FAERS ixekizumab reports were US-origin , consistent with regional reporting skew — but the enrichment hypothesis requires a dedicated drug-region classification of the 1.1 million exclusive SDRs.
If exclusive signals persist for globally marketed drugs across all four databases, regional drug availability alone cannot explain exclusivity; conversely, strong regional enrichment would imply deduplication-driven exclusivity inflates perceived database-specific toxicities. Confidence: moderate — inference, not directly tested.
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