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Pharmacovigilance01:19

Pharmacovigilance

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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
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Anticoagulant Drugs: Vitamin K Antagonists and Direct Oral Anticoagulants01:18

Anticoagulant Drugs: Vitamin K Antagonists and Direct Oral Anticoagulants

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Oral anticoagulants are vital tools in preventing and treating blood clotting disorders. This diverse class of medications can be categorized as vitamin K antagonists, exemplified by warfarin, and direct thrombin inhibitors (DTIs), such as dabigatran, as well as factor Xa inhibitors, including rivaroxaban.
Warfarin, a prominent vitamin K antagonist family member, exerts its effect by inhibiting the enzyme VKORC1 (vitamin K epoxide reductase complex 1). By hindering this enzyme, warfarin...
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Venous Thrombosis III: Interprofessional Care01:29

Venous Thrombosis III: Interprofessional Care

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Venous thrombosis requires effective prevention and treatment strategies to improve patient outcomes and reduce potential complications.Prevention StrategiesHealthcare providers must prioritize preventing venous thromboembolism (VTE) for all adult patients upon admission. Interventions depend on bleeding and thrombosis risk, medical history, current medications, diagnoses, planned procedures, and patient preferences. Patients on bed rest should change positions every two hours and, if not...
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Anticoagulant Drugs: Low-Molecular-Weight Heparins01:30

Anticoagulant Drugs: Low-Molecular-Weight Heparins

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Hemostasis is a crucial process that prevents excessive blood loss from damaged blood vessels. It involves various mechanisms such as vasoconstriction, platelet adhesion and activation, and fibrin formation. The importance of each mechanism depends on the type of vessel injury. In contrast, thrombosis is the abnormal formation of a blood clot within the blood vessels, leading to potential complications if the clot obstructs blood flow. Thrombosis can be caused by increased coagulability of the...
919
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

180
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
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Venous Thrombosis IV: Nursing Management01:30

Venous Thrombosis IV: Nursing Management

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Nursing management begins with a thorough assessment of the patient's health history. Key factors include trauma to veins, peripherally inserted central catheters, varicose veins, recent pregnancy or childbirth, surgery, bacteremia, prolonged bed rest, atrial fibrillation, COPD, heart failure, cancer, coagulation disorders, myocardial infarction, spinal cord injury, stroke, prolonged travel, recent bone fractures, and dehydration. Review medication intake, particularly oral contraceptives,...
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Related Experiment Video

Updated: Sep 16, 2025

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
23:33

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation

Published on: February 28, 2012

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Apixaban- and Rivaroxaban-Associated Bleeding: A Retrospective Analysis Using the FDA Adverse Event Reporting System.

Ilana K Logvinsky1, Christian Sanchez2, Claudiu Ciuciureanu1

  • 1Internal Medicine, Florida State University College of Medicine, Cape Coral, USA.

Cureus
|July 8, 2025
PubMed
Summary

Apixaban and rivaroxaban are anticoagulants for atrial fibrillation (AF). Rivaroxaban showed a higher risk of bleeding in multiple organ systems, suggesting apixaban may be a safer choice for certain patients.

Keywords:
anticoagulationapixabanbleedingfaersrivaroxaban

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Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
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Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
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Area of Science:

  • Pharmacology and Therapeutics
  • Clinical Medicine
  • Drug Safety

Background:

  • Atrial fibrillation (AF) necessitates anticoagulation to prevent thromboembolic events.
  • Apixaban and rivaroxaban are widely prescribed direct oral anticoagulants (DOACs).
  • Understanding comparative bleeding risks is crucial for patient management.

Purpose of the Study:

  • To compare the risk profiles of apixaban and rivaroxaban regarding various hemorrhagic events.
  • To evaluate bleeding frequencies using real-world data from the FDA Adverse Event Reporting System (FAERS).

Main Methods:

  • Data extraction from the FAERS database (January 2012 - March 2024).
  • Analysis of reported ocular, cerebral, gastrointestinal (GI), rectal, and renal hemorrhage, epistaxis, and hemoptysis.
  • Calculation of relative odds ratios (RORs) with 95% confidence intervals (CIs) for risk comparison.

Main Results:

  • No statistically significant difference in ocular hemorrhage reporting between apixaban and rivaroxaban.
  • Rivaroxaban demonstrated a significantly higher risk of cerebral, GI, rectal, and renal hemorrhage.
  • Rivaroxaban also showed increased risk for epistaxis and hemoptysis compared to apixaban.

Conclusions:

  • Apixaban may present a safer bleeding risk profile than rivaroxaban, particularly for patients with a history of specific hemorrhagic complications.
  • The findings support individualized anticoagulant selection based on patient risk factors.