Rash Associated with Dabigatran Etexilate

Abstract

Patients experiencing atrial fibrillation are at an increased risk for thromboembolic events. Therefore, anticoagulation therapy is imperative to prevent thrombus formation and stroke. Dabigatran etexilate was approved by the Food and Drug Administration in 2010 as anticoagulant prophylaxis for patients with nonvalvular atrial fibrillation. The frequency of dermatologic reactions to dabigatran etexilate is estimated in the product labeling to be less than 0.1%. To date, five cases of dabigatran etexilate-associated rash have reported, including three published cases. We describe the sixth reported case of dabigatran etexilate-associated rash, in a 59-year-old man with a history of atrial fibrillation who received dabigatran etexilate 150 mg twice/day for atrial flutter before cardioversion. The patient had taken dabigatran etexilate for 5 days before the rash was noted on hospital admission. He had no known previous drug allergies, and his platelet count, serum creatinine concentration, and hepatic function were normal. The rash resolved 7 days after the discontinuation of dabigatran etexilate, and the patient was stabilized on warfarin therapy. Use of the Naranjo Adverse Drug Reaction Probability Scale indicated a probable relationship (score of 5) between the patient's development of the rash and dabigatran etexilate therapy. Clinicians should be aware of this adverse effect of dabigatran etexilate and monitor for dermatologic reactions during follow-up visits.

A rare side effect seen due to the use of apixaban: Palmoplantar psoriasiform drug eruption

“…In contrast, anticoagulant drugs are rarely associated. Although adverse skin effects of dabigatran (8) and rivaroxaban (9) have been reported, there is no reported case report related to apixaban.…”

Probable Rivaroxaban-Induced Full Body Rash: A Case Report

“…The 3 published cases involving dabigatran describe maculopapular exanthemas, a pruritic rash, and toxic epidermal necrosis. 7 –9 There are not any reported cases for edoxaban at this time. According to the apixaban package insert, hypersensitivity reactions (including drug hypersensitivity, such as skin rash, and anaphylactic reactions, such as allergic edema) and syncope were reported in <1% of patients.…”

Hypersensitivity reactions to modern antiplatelet and anticoagulant drugs

“…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.…”