ArticleBritish journal of clinical pharmacology2017
Safety profile of the direct oral anticoagulants: an analysis of the WHO database of adverse drug reactions.
Article in British journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
26 citing papers in PubMed, 1 synthesis or guideline pooled it, 41 citations in OpenAlex.
- Drug interactions with apixaban: A systematic review of the literature and an analysis of VigiBase, the World Health Organization database of spontaneous safety reports.Pharmacology research & perspectives · 2020Pooled it
- When Atrial Fibrillation Meets Alcoholic Liver Cirrhosis: Can Direct Oral Anticoagulants Bridge the Therapeutic Gap?Biomedicines · 2026Review
- Post-marketing safety profile of dengue vaccines CYD-TDV and TAK-003: analysis of adverse event reports from a European database.Frontiers in pharmacology · 2026Article
- Vitamin K Antagonists (VKAs) and Novel Oral Anticoagulants (NOACs) Safety Comparison Based on Data from EudraVigilance Database.Hematology reports · 2025Article
- Safety of Inclisiran: A Disproportionality Analysis from the EudraVigilance Database.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Risks of oral anticoagulants: Analysis of adverse drug reactions reported to the Portuguese National Pharmacovigilance System.Pharmacology research & perspectives · 2024Article
- Drug-related problems associated with direct oral anticoagulants: an observational cross-sectional study of medical record review by pharmacists in a large teaching hospital.Research and practice in thrombosis and haemostasis · 2024Article
- Retrospective analysis of gastrointestinal bleedings with direct oral anticoagulants reported to EudraVigilance.Naunyn-Schmiedeberg's archives of pharmacology · 2023Article
- Use of SAMe-TTJournal of thrombosis and thrombolysis · 2023Article
- Relationship Amongst Vitamin K Status, Vitamin K Antagonist Use and Osteoarthritis: A Review.Drugs & aging · 2022Review
- Five Years of Direct Oral Anticoagulants Use in Italy: Adverse Drug Reactions from the Italian National Pharmacovigilance Network.Journal of clinical medicine · 2022Article
- Cutaneous Ulcer Caused by Apixaban Treatment Is Resolved after Replacement with Dabigatran.Medicina (Kaunas, Lithuania) · 2022Article
- Safety profile of tyrosine kinase inhibitors used in non-small-cell lung cancer: An analysis from the Italian pharmacovigilance database.Frontiers in oncology · 2022Article
- Vascular Brain Damage in Thalassemia Syndrome: An Emerging Challenge.Iranian journal of child neurology · 2022Review
- Risk of Bleeding Associated with Antidepressant Drugs: The Competitive Impact of Antithrombotics in Quantitative Signal Detection.Drugs - real world outcomes · 2021Article
- Spontaneous reports of adverse drug reactions related to oral anticoagulants in the Czech Republic.International journal of clinical pharmacy · 2021Article
- Comparative study of adverse drug reactions among direct-acting oral anticoagulants and vitamin K antagonists using the EudraVigilance database.Naunyn-Schmiedeberg's archives of pharmacology · 2021Article
- Drug-Drug Interactions Leading to Adverse Drug Reactions with Rivaroxaban: A Systematic Review of the Literature and Analysis of VigiBase.Journal of personalized medicine · 2021Review
- Association of Direct Oral Anticoagulants (DOACs) and Warfarin With Haemorrhagic Risk by Applying Correspondence Analysis to Data From the Italian Pharmacovigilance Database - A Case Study.Frontiers in pharmacology · 2021Article
- Drug-induced disseminated intravascular coagulation: a pharmacovigilance study on World Health Organization's database.Journal of thrombosis and thrombolysis · 2020Article
Corrections and comments
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Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimDirect oral anticoagulants (DOACs) have shown noninferiority to warfarin for stroke prevention in nonvalvular atrial fibrillation (AF) and a more promising safety profile. Unanswered safety aspects remain to be addressed and available evidence on the risk associated with these drugs are conflicting. In order to contribute to the debate on their safety profile, we conducted a comparative analysis of the reports of suspected adverse drug reactions (ADRs) associated with DOACs in VigiBase.
methodsStudy based on reports of suspected ADRs held in VigiBase as at December 2014, in which a DOAC or warfarin were administered in patients with nonvalvular AF and listed as suspected/interacting drugs. Medical Dictionary for Regulatory Activities was used to classify ADRs. Reporting odds ratio (ROR) with 95% confidence interval were calculated. Results with P ≤ 0.05 were statistically significant.
resultsWe retrieved 32 972 reports. We identified 204 ADRs with a ROR >1 (P ≤ 0.05) and we focused on 105 reactions. Positive ROR emerged for DOACs and gastrointestinal haemorrhage compared with warfarin [(1.6 (1.47-1.75)], but no disproportionality with cerebral haemorrhage was found [0.31 (0.28-0.34)]. We identified other potential signals that have not been associated with DOACs previously.
conclusionsAs well as premarketing authorization clinical trial studies, we found a reduced risk of intracranial haemorrhage, but an increased risk of gastrointestinal haemorrhage in patients treated with DOACs compared to warfarin. We provide new data and we highlight several differences between the three novel oral anticoagulants, in the rate and type of ADRs occurred.
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