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Oral anticoagulant drugs and CNS-related hematomas: a pharmacovigilance analysis from the FAERS database
1Department of Pharmacy, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, School of Clinical Medicine, Henan University, Zhengzhou, Henan, 450003, China.
Insights
Oral anticoagulant (OAC) therapy is linked to central nervous system (CNS) hematoma adverse events (hAEs). Warfarin showed the highest risk, while advanced age and low weight increased mortality risk for these early-onset events.
Area of Science:
- Pharmacovigilance
- Neurology
- Cardiology
Background:
- Central nervous system (CNS) hematoma adverse events (hAEs) are severe complications in patients on oral anticoagulant (OAC) therapy.
- Understanding the comparative risk of different OACs for CNS-hAEs is crucial for patient safety.
Purpose of the Study:
- To analyze and characterize the risk of CNS-related hAEs across various OACs.
- To identify risk factors for mortality and temporal patterns of CNS-hAEs.
Main Methods:
- Analysis of CNS-hAEs from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database.
- Disproportionality analysis (reporting odds ratio) to identify OAC-specific signals.
- Logistic regression for mortality risk factors and time-to-onset analysis for temporal patterns.
Main Results:
- All OACs showed positive signals for CNS-hAEs, with warfarin having the highest association (ROR=38.31).
- Subdural hematoma was the most common type (74.0%).
- Independent mortality predictors included advanced age (≥75 years), low body weight (<60 kg), multiple adverse events, and antidepressant use. Warfarin had a longer median onset time (435.5 days) compared to NOACs (158.5-228.0 days).
Conclusions:
- OACs are associated with CNS-hAEs, with varying risks among agents.
- Advanced age, low body weight, multiple AEs, and antidepressant use are key mortality risk factors.
- CNS-hAEs generally occur early in treatment, necessitating optimized risk management strategies.
Objective:
Central nervous system (CNS)-related hematoma adverse events (hAEs) are serious and devastating complications in patients receiving oral anticoagulant (OAC) therapy. We aimed to analyze and characterize the risk of CNS-related hAEs across different OACs.
Methods:
We analyzed CNS-related hAEs from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database. Disproportionality analysis was conducted to identify signals for each OAC. Logistic regression was used to assess mortality risk factors, while time-to-onset analysis characterized temporal patterns.
Results:
A total of 5501 patients and 5641 CNS-related hAE reports were associated with OACs. Disproportionality analysis identified positive signals for all OACs, with warfarin showing the highest association (reporting odds ratio [ROR] = 38.31), followed by dabigatran (ROR = 22.76), rivaroxaban (ROR = 20.51), edoxaban (ROR = 16.81), and apixaban (ROR = 12.53). Subdural hematoma was the most frequently reported type (74.0 %). In multivariate analysis, age ≥75 years, weight <60 kg, multiple adverse events (AEs), and concomitant antidepressant use were independent predictors of mortality. All OACs exhibited early failure-type temporal profiles, with warfarin demonstrating a significantly longer median onset time (435.5 days) compared to non-vitamin K antagonist oral anticoagulants (NOACs, 158.5-228.0 days; P < 0.001).
Conclusion:
OACs are associated with CNS-related hematomas, with varying risk profiles among agents. Advanced age, low body weight, multiple AEs, and concomitant antidepressant use are crucial mortality risk factors. CNS-related hAEs typically occur early during treatment. These findings provide insights for optimizing risk management and support appropriate anticoagulation when clinically indicated.
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