ArticleInternational journal of surgery (London, England)2026
Antiplatelet therapy and central nervous system hematomas: a cohort study using real-world data from the FAERS and VigiAccess databases.
Article in International journal of surgery (London, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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2 citing papers in PubMed.
- Potential risk signals for drug-related osteomyelitis: a comprehensive disproportionality analysis based on the FDA Adverse Event Reporting System (FAERS) database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Adverse events associated with ustekinumab in Crohn's disease treatment: an analysis based on the FAERS database.Frontiers in medicine · 2025Article
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Abstract
backgroundAntiplatelet therapy is a cornerstone in the management of atherosclerotic cardiovascular disease. However, the risk profile of central nervous system (CNS) hematomas associated with antiplatelet agents remains incompletely characterized.
methodsWe analyzed CNS-related hematoma adverse event (hAE) reports across the four antiplatelet drugs, using data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) and the World Health Organization's VigiAccess databases. Disproportionality analysis was conducted to identify positive signals. Stratified analysis assessed risk differentials by age and gender, time-to-onset analysis characterized temporal patterns, and a global assessment of the evidence was established.
resultsA total of 2274 CNS-related hAE reports were identified in FAERS and 7229 in VigiAccess. All four antiplatelet drugs demonstrated significant disproportionality signals, with clopidogrel [FAERS: reporting odds ratio (ROR), 26.79; VigiAccess: ROR: 36.69] and aspirin (FAERS: ROR, 22.06; VigiAccess: ROR, 40.13) showing the strongest associations, followed by prasugrel (FAERS: ROR, 16.91; VigiAccess: ROR, 24.02), and ticagrelor (FAERS: ROR, 8.07; VigiAccess: ROR, 9.80). Subdural hematomas were the most frequently reported subtype (FAERS: 63.11%; VigiAccess: 62.72%). Female patients exhibited stronger signals than males across all drugs. All antiplatelet drugs revealed early failure-type temporal profiles, with median onset times ranging from 12.0 days for ticagrelor to 442.5 days for aspirin ( P < 0.001).
conclusionsWe found a disproportionately significant association between antiplatelet therapy and CNS-related hematomas, with distinct patterns observed across drug types, patient demographics, and temporal profiles. These findings provide critical insights to inform risk stratification, clinical decision-making, and safety monitoring in patients undergoing antiplatelet therapy.
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