Apixaban Causing Leukocytoclastic Vasculitis

Nasir, Usama; Kumar, Aswini; Easwar, Arti

doi:10.1016/j.jaip.2017.12.007

Cited by 23 publications

(30 citation statements)

References 3 publications

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“…22 During routine postmarketing surveillance, the U.S. Food and Drug Administration (FDA) Division of Pharmacovigilance identified postmarketing cases of CSVV reported after DOAC exposure. [23][24][25][26] This prompted a review of all CSVV cases submitted to the U.S. FDA Adverse Event Reporting System (FAERS) database and published in the medical literature. Furthermore, we characterized this signal in the Sentinel System to relate the clinical data from the individual FAERS cases to population-based electronic healthcare data.…”

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confidence: 99%

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Complementary Use of U.S. FDA’s Adverse Event Reporting System and Sentinel System to Characterize Direct Oral Anticoagulants‐Associated Cutaneous Small Vessel Vasculitis

Mohamoud

Horgan²,

Eworuke

et al. 2020

Pharmacotherapy

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BACKGROUND Cutaneous small vessel vasculitis (CSVV) has been reported after exposure to direct oral anticoagulants (DOACs), such as dabigatran, rivaroxaban, apixaban, and edoxaban. OBJECTIVE We used the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) to describe clinical characteristics associated with CSVV among DOAC-exposed patients. Furthermore, we characterized this signal in the Sentinel System to relate the clinical data from the individual FAERS cases to population-based electronic healthcare data. METHODS We queried FAERS for all cases of CSVV associated with DOACs from U.S. approval date of each DOAC through March 16, 2018. Within the Sentinel System, we identified incident CSVV cases using ICD-9 and ICD-10 diagnosis codes among adults aged ≥ 30 years who received a DOAC in the prior 90 days between January 1, 2010, and June 30, 2018. We excluded patients with evidence of select autoimmune diagnoses in the 183 days prior to their CSVV diagnoses and reported patient characteristics in the 183-day period prior to CSVV diagnoses. RESULTS In FAERS, we identified 50 cases of CSVV reported with rivaroxaban (n=26), apixaban (n=14), dabigatran (n=9), and edoxaban (n=1). Approximately 50% of the cases reported time to onset within 10 days after DOAC exposure. When specified, the predominant type of CSVV

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confidence: 99%

“…During routine postmarketing surveillance, the U.S. Food and Drug Administration (FDA) Division of Pharmacovigilance identified postmarketing cases of CSVV reported after DOAC exposure 23–26 . This prompted a review of all CSVV cases submitted to the U.S. FDA Adverse Event Reporting System (FAERS) database and published in the medical literature.…”

mentioning

confidence: 99%

Complementary Use of U.S. FDA’s Adverse Event Reporting System and Sentinel System to Characterize Direct Oral Anticoagulants‐Associated Cutaneous Small Vessel Vasculitis

Mohamoud

Horgan²,

Eworuke

et al. 2020

Pharmacotherapy

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“…The patient was successfully switched to rivaroxaban. One case of leukocytoclastic vasculitis was described after 10 days of apixaban (28), appearing as an erythematous rash of lower limbs quickly evolving into purpuric itchy and burning rash. On biopsy evaluation IgA and C3 stained positive at a perivascular level; infiltration of neutrophils was described around and inside the superficial vascular plexus together with focal fibrinoid vessel wall necrosis and in association with erythrocyte extravasation.…”

Section: Hypersensitivity Reactions To Rivaroxabanmentioning

confidence: 99%

Hypersensitivity reactions to non-vitamin K oral anticoagulants - a review of literature and diagnostic work-up proposal

Carli

Farsi

Chiarini

et al. 2019

Eur Ann Allergy Clin Immunol

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Non-vitamin K antagonist oral anticoagulants (NOACs) are increasingly being used in hospital and outpatient settings as safe alternatives to warfarin. Hypersensitivity reactions have been described for NOACs and can be classified according to Gell and Coombs. We reviewed case reports of possible drug hypersensitivity reactions, noticing a predominance of delayed reactions (both mild and severe) and the absence of cross-reactions to warfarin and low molecular weight heparins. International experience on diagnostic tests is lacking. The vast majority of authors refer to probability scores and rely on biopsy to classify vasculitis and rule out differential diagnoses. We propose to adapt available tests to confirm the patient's reactivity to new anticoagulants. Among in vivo tests, patch testing revealed promising in delayed reactions.

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“…8 Availability of case reports describing apixaban-induced hypersensitivity reactions are limited, and very few, if any, describe experience on diagnostic or biopsy tests. 9 – 11 In addition, the cross reactivity across DOACs as a class is also unknown. To the best of our knowledge, there is currently no reported case of lichenoid eruption induced by apixaban.…”

Section: Introductionmentioning

confidence: 99%

A rare case report of apixaban-induced lichenoid eruption

Patil

Hanna

Torre

2020

Therapeutic Advances in Drug Safety

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With recent increase in the use of direct oral anticoagulants (DOACs), several new cases of adverse drug reactions (ADRs) have been identified in pharmacovigilance surveys. These ADRs can result in significant mortality and morbidity if not identified and treated promptly. It is important for physicians to recognize that immunologically mediated delayed hypersensitivity reactions, although rare in occurrence, can have significant impact on patient’s quality of life. To the best of our knowledge, we report the first case of lichenoid eruption associated with apixaban. We further provide evidence of tolerance to rivaroxaban in the same patient. Plain language summary Apixaban-induced lichenoid eruption Well documented case reports, although providing evidence of probable causal relationship between a drug and specific adverse drug reactions (ADRs), can increase awareness amongst clinicians treating patients with direct oral anticoagulants (DOACs), especially with its rapid utilization. Rare ADRs are difficult to detect as clinical trials of DOACs lacked enough patient sample, making post-marketing reporting of such events important so both patients and clinicians can be vigilant to help with prompt recognition of such symptoms. We report the first case of lichenoid eruption hypersensitivity reaction associated with apixaban in patient with tolerance to rivaroxaban.

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Apixaban Causing Leukocytoclastic Vasculitis

Cited by 23 publications

References 3 publications

Complementary Use of U.S. FDA’s Adverse Event Reporting System and Sentinel System to Characterize Direct Oral Anticoagulants‐Associated Cutaneous Small Vessel Vasculitis

Complementary Use of U.S. FDA’s Adverse Event Reporting System and Sentinel System to Characterize Direct Oral Anticoagulants‐Associated Cutaneous Small Vessel Vasculitis

Hypersensitivity reactions to non-vitamin K oral anticoagulants - a review of literature and diagnostic work-up proposal

A rare case report of apixaban-induced lichenoid eruption

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