Apixaban-induced hepatotoxicity

Cordeanu, Elena-Mihaela; Lambert, Aude; Gærtner, S.; Nouri, Saeed; Mirea, C.; Alt-Tebacher, Martine; Stephan, Dominique

doi:10.1016/j.ijcard.2015.11.147

Cited by 14 publications

(15 citation statements)

References 8 publications

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“…Although all the three anticoagulants (warfarin, enoxaparin, and apixaban) might lead to hepatotoxicity [7,11], enoxaparin was given after warfarin-induced cholestasis [13] and apixaban-induced cholestasis [11]. However, this is a unique case report that combined warfarin, and apixaban-related liver injury occurred in the same patient.…”

Section: Discussionmentioning

confidence: 87%

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Effectiveness of apixaban in warfarin hepatotoxicity: A case report

Alaklabi¹,

Alotaibi²,

Alotaibi³

et al. 2017

IJMDC

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Background: Apixaban is a direct and competitive inhibitor of factor Xa. It has been shown to be effective and safe to Prevent Stroke in Atrial Fibrillation Patients. This study is a case report of warfarin-induced cholestasis that occurred one week after starting warfarin for deep venous thrombosis, in which the cholestasis improved after the offending drug was stopped but worsened after beginning apixaban.

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Section: Discussionmentioning

confidence: 87%

“…The mechanisms of warfarin and apixaban induced liver damage is unknown but has been suggested to be an idiosyncratic reaction [11,12].…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of apixaban in warfarin hepatotoxicity: A case report

Alaklabi¹,

Alotaibi²,

Alotaibi³

et al. 2017

IJMDC

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“…It is suggested that patients with prior liver injury may be at a higher risk of apixaban-induced hepatotoxicity 8. Also, concomitant administration of CYP3A4 inhibitors (like certain antimicrobials) may precipitate apixaban-induced liver injury 9…”

Section: Discussionmentioning

confidence: 99%

“…Few case reports have described drug-induced hepatotoxicity in patients receiving DOACs such as apixaban and rivaroxaban 2 8. A meta-analysis of 152 116 patients in 29 stage III clinical trials concluded that there was no increased risk of hepatotoxicity with DOACs 10.…”

Section: Discussionmentioning

confidence: 99%

“…A meta-analysis of 152 116 patients in 29 stage III clinical trials concluded that there was no increased risk of hepatotoxicity with DOACs 10. However, case reports, pharmacovigilance data and patient series reveal hepatotoxicity associated with DOACs in patients with normal and impaired liver function 2 8 10 11. Of all available DOACs, apixaban is less frequently associated with hepatotoxicity 12 13.…”

Section: Discussionmentioning

confidence: 99%

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Apixaban-induced liver injury

Clarke

Alsaad²,

Mack

et al. 2016

BMJ Case Reports

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An 81-year-old woman with well-controlled hypertension presented to the emergency department with new-onset atrial fibrillation with rapid ventricular response. Treatment for atrial fibrillation was initiated, including rate control and anticoagulation with 5 mg of apixaban two times per day for primary stroke prophylaxis. Three days after initiation of apixaban, the patient noted new-onset abdominal pain, worsening shortness of breath and weakness. Laboratory results showed elevated liver enzymes. Workup for elevated transaminase did not reveal any underlying infectious or autoimmune process. Apixaban, a probable cause for the hepatocellular injury, was discontinued and replaced with intravenous unfractionated heparin to bridge anticoagulation with warfarin. The patient's symptoms resolved as her transaminases improved by discontinuation of apixaban. We illustrate this case of drug-induced hepatotoxicity secondary to treatment with apixaban. It is important for physicians to be aware of this rare adverse effect caused by a widely used novel oral anticoagulant.

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Non-bleeding Adverse Events with the Use of Direct Oral Anticoagulants: A Sequence Symmetry Analysis

et al. 2018

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IntroductionPostmarketing pharmacovigilance reports have raised concerns about non-bleeding adverse events associated with direct oral anticoagulants (DOACs), but only limited results are available from large claims databases.ObjectiveThe aim of this study was to assess the potential association between DOAC initiation and the onset of four types of non-bleeding adverse events by sequence symmetry analysis (SSA).MethodsSSA was performed using nationwide data from the French National Healthcare databases (Régime Général, 50 million beneficiaries) to assess a cohort of 386,081 DOAC new users for the first occurrence of four types of non-bleeding outcomes: renal, hepatic, skin outcomes identified by using hospitalization discharge diagnoses, and gastrointestinal outcomes by using medication reimbursement. Asymmetry in the distribution of each investigated outcome occurring before and after initiation of DOAC therapy was used to test the association between DOAC therapy and these outcomes. SSA inherently controls for time-constant confounders, and adjusted sequence ratios were computed after correcting for temporal trends. Negative (glaucoma) and positive (bleeding, depressive disorders) control outcomes were used and analyses were replicated on a cohort of 310,195 patients initiating a vitamin K antagonist (VKA).ResultsThis study demonstrated the expected positive association between either DOAC or VKA therapy and hospitalised bleeding and initiation of antidepressant therapy, while no association was observed between either DOAC or VKA therapy and initiation of antiglaucoma medications. For DOAC therapy, signals were the associations with hepatic outcomes, including acute liver injury [for the 3-month time window, aSR3 = 2.71, 95% confidence interval (CI) 1.79–4.52]; gastrointestinal outcomes, including initiation of drugs for constipation and antiemetic drugs (aSR3 = 1.31, 95% CI 1.27–1.36; and 1.17, 95% CI 1.12–1.22, respectively); and kidney diseases (aSR3 = 1.33, 95% CI 1.29–1.37).ConclusionResults of this nationwide study suggest that DOACs are associated with rare but severe liver injury and more frequent gastrointestinal disorders. A low risk of kidney injury with DOAC therapy can also not be excluded.Electronic supplementary materialThe online version of this article (10.1007/s40264-018-0668-9) contains supplementary material, which is available to authorized users.

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Apixaban-induced hepatotoxicity

Cited by 14 publications

References 8 publications

Effectiveness of apixaban in warfarin hepatotoxicity: A case report

Effectiveness of apixaban in warfarin hepatotoxicity: A case report

Apixaban-induced liver injury

Non-bleeding Adverse Events with the Use of Direct Oral Anticoagulants: A Sequence Symmetry Analysis

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