ArticleBritish journal of clinical pharmacology2015
Liver injury with novel oral anticoagulants: assessing post-marketing reports in the US Food and Drug Administration adverse event reporting system.
Article in British journal of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 2 of them syntheses that pooled it.
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Who cites it
32 citing papers in PubMed, 2 syntheses or guidelines pooled it, 82 citations in OpenAlex.
- Real-world use of nonvitamin K antagonist oral anticoagulant in atrial fibrillation patients with liver disease: A meta-analysis.Clinical cardiology · 2020Pooled it
- Comparative Effectiveness and Safety of Direct Oral Anticoagulants: Overview of Systematic Reviews.Drug safety · 2019Pooled it
- Comparators in Pharmacovigilance: A Quasi-Quantification Bias Analysis.Drug safety · 2024Article
- Machine Learning to Predict Drug-Induced Liver Injury and Its Validation on Failed Drug Candidates in Development.Toxics · 2024Article
- The Challenge of Anticoagulation in Liver Cirrhosis.Visceral medicine · 2024Review
- Case report: Severe hepatopathy following rivaroxaban administration in a dog.Frontiers in veterinary science · 2024Article
- Liver injury in children: signal analysis of suspected drugs based on the food and drug administration adverse event reporting system.BMC pediatrics · 2023Article
- Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems.Frontiers in drug safety and regulation · 2023Review
- Systemic quinolones and risk of retinal detachment III: a nested case-control study using a US electronic health records database.European journal of clinical pharmacology · 2022Article
- Drug-Drug Interactions of Direct Oral Anticoagulants (DOACs): From Pharmacological to Clinical Practice.Pharmaceutics · 2022Review
- Liver Injury Among Japanese Patients Treated Using Prophylactic Enoxaparin After Colorectal Surgery.Digestive diseases and sciences · 2021Article
- Systemic quinolones and risk of acute liver failure I: Analysis of data from the US FDA adverse event reporting system.JGH open : an open access journal of gastroenterology and hepatology · 2021Article
- Acute liver failure after changing oral anticoagulant from apixaban to rivaroxaban.BMJ case reports · 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
- Drug interactions of direct oral anticoagulants in elderly patients with cardiometabolic diseases.Current research in pharmacology and drug discovery · 2021Review
- Nontumoral Portal Vein Thrombosis: A Challenging Consequence of Liver Cirrhosis.Journal of clinical and translational hepatology · 2020Review
- Anticoagulants and Their Monitoring.Clinical liver disease · 2020Review
- Association between oral anticoagulants and osteoporosis: Real-world data mining using a multi-methodological approach.International journal of medical sciences · 2020Article
- Comparison of Safety Profiles of New Oral Anticoagulants with Warfarin Using the Japanese Spontaneous Reporting Database.Clinical drug investigation · 2019Article
- Non-bleeding Adverse Events with the Use of Direct Oral Anticoagulants: A Sequence Symmetry Analysis.Drug safety · 2018Article
Corrections and comments
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Authors and funding
9 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimWe assessed the hepatic safety of novel oral anticoagulants (NOACs) analyzing the publicly available US-FDA adverse event reporting system (FAERS).
methodsWe extracted reports of drug-induced liver injury (DILI) associated with NOACs, including acute liver failure (ALF) events. Based on US marketing authorizations, we performed disproportionality analyses, calculating reporting odds ratios (RORs) with 95% confidence interval (CI), also to test for event- and drug-related competition bias, and case-by-case evaluation for concomitant medications.
resultsDILI reports represented 3.7% (n = 146) and 1.7% (n = 222) of all reports for rivaroxaban and dabigatran, respectively. No statistically significant association was found for dabigatran, in primary and secondary analyses. Disproportionality signals emerged for rivaroxaban in primary analysis (ALF: n = 25, ROR = 2.08, 95% CI 1.34, 3.08). In a large proportion of DILI reports concomitant hepatotoxic and/or interacting drugs were recorded: 42% and 37% (rivaroxaban and dabigatran, respectively), especially statins, paracetamol and amiodarone. Among ALF reports, fatal outcome occurred in 49% of cases (44% and 51%, rivaroxaban and dabigatran, respectively), whereas rapid onset of the event (<1 week) was detected in 46% of patients (47% and 44%, respectively).
conclusionsThe disproportionality signal for rivaroxaban calls for further comparative population-based studies to characterize and quantify the actual DILI risk of NOACs, taking into account drug- and patient-related risk factors. As DILI is unpredictable, our findings strengthen the role of (a) timely pharmacovigilance to detect post-marketing signals of DILI through FAERS and other data sources, (b) clinicians to assess early, on a case-by-case basis, the potential responsibility of NOACs when they diagnose a liver injury.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.