Dabigatran-Induced Acute Hepatitis

Rochwerg, Bram; Xenodemetropoulos, Ted; Crowther, Mark; Spyropoulos, Alex C.

doi:10.1177/1076029611435840

Cited by 18 publications

(14 citation statements)

References 4 publications

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“…Though seemingly rare, case reports and case series have described hepatotoxicity linked to the use of vitamin K antagonists,[20] dabigatran,[9] rivaroxaban,[10] and apixaban. [21] These isolated reports, as well as analysis of pharmacovigilance databases, are unsuitable to compare the risk of liver injury across different oral anticoagulants since they lack well-defined denominators.…”

Section: Discussionmentioning

confidence: 99%

“…[8] More recently, isolated cases of liver injury associated with the use of dabigatran and rivaroxaban have been published. [9, 10] Though the available results from published randomized trials do not support a higher risk of hepatotoxicity or liver injury in patients using approved DOACs compared to those using warfarin,[11] no data from large, real-world populations of DOAC users with AF are available. Moreover, identifying predictors of liver toxicity among users of oral anticoagulants may inform prescribing decisions and help flag patients at higher risk of this complication, who could require more frequent liver function monitoring.…”

Section: Introductionmentioning

confidence: 99%

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Prospective study of oral anticoagulants and risk of liver injury in patients with atrial fibrillation

Alonso

MacLehose

Chen

et al. 2017

Heart

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Objective To assess the risk of liver injury hospitalization in patients with atrial fibrillation (AF) after initiation of direct oral anticoagulants (DOACs) or warfarin and to determine predictors of liver injury hospitalization in this population. Methods We studied 113,717 patients (mean age 70, 39% women) with AF included in the MarketScan® Commercial and Medicare Supplemental databases with a first prescription for oral anticoagulation after November 4, 2011, followed through December 31, 2014. Of these, 56,879 initiated warfarin, 17,286 initiated dabigatran, 30,347 initiated rivaroxaban, and 9,205 initiated apixaban. Liver injury hospitalization and comorbidities were identified from healthcare claims. Results During a median follow-up of 12 months, 960 hospitalizations with liver injury were identified. Rates of liver injury hospitalization (per 1000 person-years) by oral anticoagulant were 9.0 (warfarin), 4.0 (dabigatran), 6.6 (rivaroxaban), and 5.6 (apixaban). After multivariable adjustment, liver injury hospitalization rates were lower in initiators of DOACs compared to warfarin: hazard ratios (HR) [95% confidence interval (95%CI)] of 0.57 (0.46, 0.71), 0.88 (0.75, 1.03) and 0.70 (0.50, 0.97) for initiators of dabigatran, rivaroxaban, and apixaban, respectively (vs. warfarin). Compared to dabigatran initiators, rivaroxaban initiators had a 56% increased risk of liver injury hospitalization (HR 1.56, 95%CI: 1.22, 1.99). In addition to type of anticoagulant, prior liver, gallbladder, and kidney disease, cancer, anemia, heart failure, and alcoholism significantly predicted liver injury hospitalization. A predictive model including these variables had adequate discriminative ability (C-statistic 0.67, 95%CI 0.64, 0.70). Conclusion Among patients with non-valvular AF, DOACs were associated with lower risk of liver injury hospitalization compared to warfarin, with dabigatran showing the lowest risk.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Prospective study of oral anticoagulants and risk of liver injury in patients with atrial fibrillation

Alonso

MacLehose

Chen

et al. 2017

Heart

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“…For ximelagatran, HLA-dependent allergic toxicity is a likely mechanism [6,7]. In the only case report about dabigatran-associated hepatotoxicity, no allergic features were reported [34]. This does not support, but does also not exclude, an allergic mechanism.…”

Section: Potential Mechanisms Of Noac-associated Liver Toxicitymentioning

confidence: 92%

“…A 71-year-old man with AF was treated with dabigatran for stroke prevention [34]. After 1 month of treatment, he presented with jaundice and malaise.…”

Section: Case Reports and Case Seriesmentioning

confidence: 99%

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Hepatotoxicity of New Oral Anticoagulants (NOACs)

2015

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Case reports and analyses of clinical studies and of pharmacovigilance data suggest that new oral anticoagulants (NOACs) are associated with a small risk for hepatotoxicity. The objective of this publication is to summarize the current data about this subject, with a special emphasis on pharmacovigilance data in the World Health Organization (WHO) Global Individual Case Safety Reports (ICSR) database and on potential mechanisms of hepatotoxicity. For that, all available case reports as well as published analyses of clinical studies were obtained with a detailed search in PubMed. In addition, pharmacovigilance data from VigiBase(®), the WHO Global ICRS database, were extracted and analyzed. The data show that liver injury associated with NOACs was reported in clinical studies and in pharmacovigilance databases. Several case reports described potentially life-threatening hepatotoxicity in patients treated with rivaroxaban or dabigatran. For rivaroxaban, most affected patients were symptomatic and liver injury was most often hepatocellular or mixed. The frequency was between 0.1 and 1 % in clinical studies and was by trend lower than for comparators (mostly enoxaparin or warfarin). Comparing the pharmacovigilance reports for the individual NOACs, more hepatic adverse events were reported for rivaroxaban than for dabigatran or apixaban. With the exception of edoxaban, for which only few reports are available, patients with acute liver failure have been reported for every NOAC, but most patients had concomitant drugs or diseases. So far, there are no clear mechanisms explaining the hepatotoxicity of these drugs. We conclude that hepatotoxicity appears to be associated with all NOACs currently on the market. Hepatotoxicity associated with NOACs is idiosyncratic; it appears at therapeutic doses, is rare and the mechanism is not related to the pharmacological action of these drugs. Prescribers should inform patients about possible symptoms of hepatotoxicity and stop these drugs in patients presenting with severe liver injury.

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Neurological Complications of Anticoagulation

Giraldo

Botero

2022

Transfusion Practice in Clinical Neurosciences

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Dabigatran-Induced Acute Hepatitis

Cited by 18 publications

References 4 publications

Prospective study of oral anticoagulants and risk of liver injury in patients with atrial fibrillation

Prospective study of oral anticoagulants and risk of liver injury in patients with atrial fibrillation

Hepatotoxicity of New Oral Anticoagulants (NOACs)

Neurological Complications of Anticoagulation

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