title: Drug-induced exanthem following dabigatran.
abstract: OBJECTIVE
  To report an incident of a drug-induced exanthem during treatment with dabigatran in a patient without prior exposure to the drug.
  
  
  METHODS
  A 20-year-old white male was prescribed oral dabigatran 150 mg twice daily for thromboembolic prevention because of nonvalvular atrial fibrillation. After 2 weeks of dabigatran therapy, a raised, pruritic, erythematous rash developed on the patient's inner thigh and forearm. Upon discontinuation of dabigatran and initiation of oral corticosteroid treatment, the rash resolved. Dabigatran therapy was not readministered and thromboembolic prevention therapy with warfarin was instituted.
  
  
  CONCLUSIONS
  The clinical evidence for efficacy of dabigatran was derived largely from the RE-LY trial, which provided an open-label comparison with warfarin for the reduction of stroke and systemic embolism in nonvalvular atrial fibrillation. The most frequent adverse reactions leading to discontinuation of dabigatran were bleeding and gastrointestinal events. In the RE-LY study, drug hyper-sensitivity, allergic edema, anaphylactic reaction, and anaphylactic shock were reported in <0.1% of patients receiving dabigatran. Despite the low incidence of hypersensitivity reported in the RE-LY trial, the use of the Naranjo probability scale indicated a probable relationship between the rash and dabigatran therapy in this patient.
  
  
  CONCLUSIONS
  Upon initiation of dabigatran therapy, surveillance for hyper-sensitivity reactions should be included as part of routine drug monitoring.
authors: The Ohio State University School of Pharmacy, Columbus, OH, USA.
authors: Heather
authors: H
authors: Whitehead
authors: J Michael
authors: JM
authors: Boyd
authors: Danielle M
authors: DM
authors: Blais
authors: John
authors: J
authors: Hummel
mesh_terms: D000328:Adult; D000991:Antithrombins / Q000009:adverse effects* / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000503:physiopathology; D001562:Benzimidazoles / Q000009:adverse effects* / Q000627:therapeutic use; D000069604:Dabigatran; D004342:Drug Hypersensitivity / Q000503:physiopathology*; D016903:Drug Monitoring; D005076:Exanthema / Q000188:drug therapy / Q000209:etiology* / Q000276:immunology*; D006801:Humans; D008297:Male; D013923:Thromboembolism / Q000209:etiology / Q000517:prevention & control; D016896:Treatment Outcome; D055815:Young Adult; D015091:beta-Alanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000991:Antithrombins; D001562:Benzimidazoles; D015091:beta-Alanine; D000069604:Dabigatran