Drug-Induced Exanthem Following Dabigatran

Whitehead, Heather; Boyd, Jessica M.; Blais, Danielle; Hummel, John D.

doi:10.1345/aph.1q317

Cited by 14 publications

(13 citation statements)

References 6 publications

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“…The reaction resolved in 5 -7 days after dabigatran discontinuation. It is pertinent to note that in most of the cases, the drug reaction was not confirmed using serum biomarkers for allergic reactions or skin testing neither were the patients re-challenged [27,28]. Our case study provides an advantage over previously published case reports as we not only report rivaroxabaninduced urticarial and angioedema but also the evidence of cross-reactivity to dabigatran.…”

Section: Discussionmentioning

confidence: 78%

A Case Report of Rivaroxaban-Induced Urticaria and Angioedema With Possible Cross-Reaction to Dabigatran

Patil

Ikekwere

2019

J Med Cases

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Anticoagulants are commonly associated with hemorrhagic complications. However, rare hypersensitivity drug reactions associated with direct oral anticoagulants (DOACs) in form of cutaneous reactions such as urticaria as well as angioedema can have significant burden owing to increase in morbidity and mortality. Angioedema can be allergic, hereditary or idiopathic and can occur in isolation, in combination with urticaria as contributing component of anaphylaxis. With increase in the use of DOACs over warfarin as choice of anticoagulant in the treatment of atrial fibrillation (AF) as well as venous thromboembolism (VTE), recent post marketing surveillance has identified several reports of adverse drug reactions. This case report describes the clinical course of patient being treated for VTE, who experienced rivaroxaban-induced urticaria and angioedema. We further provide evidence for cross-reactivity to dabigatran manifested as significant cutaneous reaction. Patient was transitioned to warfarin with enoxaparin bridge and tolerated it well without any complications.

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Section: Discussionmentioning

confidence: 78%

A Case Report of Rivaroxaban-Induced Urticaria and Angioedema With Possible Cross-Reaction to Dabigatran

Patil

Ikekwere

2019

J Med Cases

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“…The number of patients being treated with dabigatran etexilate continues to rise, however, there is a growing body of evidence being reported in the postmarketing surveillance literature to suggest that the potential risks of this drug are not generally appreciated 13,14,15,16,17. From the pivotal Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) study, bleeding is an expected complication with dabigatran etexilate (the incidence of major bleeding depending on the dose administered was 2.7-3.1%) 18.…”

Section: Discussionmentioning

confidence: 99%

Adverse events in patients initiated on dabigatran etexilate therapy in a pharmacist-managed anticoagulation clinic

Donaldson

Norbeck

2013

Pharmacy Practice (Internet)

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BackgroundVitamin K antagonists have been the treatment of choice in preventing thromboembolic events, but problems such as frequent dose adjustment and monitoring of coagulation status, including multiple drug and food interactions, make their use difficult. Dabigatran etexilate is a new oral direct thrombin inhibitor not requiring routine monitoring and since its approval in the United States, many clinicians have been interested in utilizing this new therapy.ObjectiveThis study documented adverse drug events (ADEs) recorded in patients started on dabigatran therapy, including those who were previously controlled on warfarin and those who were anticoagulant naïve.MethodsIn an outpatient pharmacist-managed anticoagulation clinic, a total of 221 patients were initiated on dabigatran therapy over an 18-month period. 43.0% of these patients were previously controlled on warfarin.Results54 of the 221 patients (24.4%) developed an ADE while on dabigatran. The average time to event was 48.4 days. Nine of the fifty-four patients experienced a major bleeding ADE; six patients developed a serious non-bleeding ADE. Five of these fifteen patients died; one death was directly related to dabigatran therapy. The remaining thirty-nine of the fifty-four patients experienced a clinically relevant non-major ADE. Of the fifty-four patients who experienced an ADE, thirty were male. The average age was 73.8 years and the average weight was 92.8kg. Fifty-four percent of those who experienced an ADE were previously anticoagulant naïve.ConclusionsWhile many clinicians have been interested in utilizing the new direct thrombin inhibitor dabigatran etexilate, this new therapy is not without risks. This study documented adverse drug events in 24.4% of patients who were initiated on dabigatran etexilate therapy over an eighteen month period. ADEs were more common in patients who were anticoagulant naïve prior to dabigatran etexilate therapy and not those who were previously controlled on warfarin therapy.

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“…According to the approval trial RE-LY, as well as the post-marketing data, hypersensitivity reactions are rare [ 49 ]. Individual cases of sometimes pronounced maculopapular exanthemas, some involving pruritus, are described [ 45 , 50 ]. Although a possible association with TEN in an 86-year-old female patient was reported in one case [ 51 ], it was not possible to conclusively establish a causal link.…”

Section: Anticoagulantsmentioning

confidence: 99%

Hypersensitivity reactions to modern antiplatelet and anticoagulant drugs

Scherer

2015

Allergo J Int

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Anticoagulation and antiplatelet drugs are among the most commonly used medical drugs. In addition to the long-established heparins, hirudins, coumarins and antiplatelet drugs such as acetylsalicylic acid, numerous novel and predominantly synthetic pharmacologic agents have come onto the market in recent years. These new agents act at various sites in coagulation and have significantly broadened treatment options. Whilst immunological hypersensitivity reactions are on the whole rare, they have a considerable impact on patient management when they do occur. The present overview discusses the currently known hypersensitivity reactions to anticoagulant and antiplatelet agents, with particular attention to the newer substance classes including P2Y12 inhibitors, glycoprotein IIb/IIIb receptor antagonists, direct factor Xa inhibitors and direct thrombin inhibitors.

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Drug-Induced Exanthem Following Dabigatran

Abstract: Upon initiation of dabigatran therapy, surveillance for hyper-sensitivity reactions should be included as part of routine drug monitoring.

Cited by 14 publications

References 6 publications

A Case Report of Rivaroxaban-Induced Urticaria and Angioedema With Possible Cross-Reaction to Dabigatran

A Case Report of Rivaroxaban-Induced Urticaria and Angioedema With Possible Cross-Reaction to Dabigatran

Adverse events in patients initiated on dabigatran etexilate therapy in a pharmacist-managed anticoagulation clinic

Hypersensitivity reactions to modern antiplatelet and anticoagulant drugs

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