Fluindione and drug reaction with eosinophilia and systemic symptoms: an unrecognised adverse effect?

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  • Additional Information
    • Corporate Authors:
      French Pharmacovigilance Centres Network and The Toxidermia Group of the French Society of Dermatology
    • Source:
      Publisher: Springer Country of Publication: Germany NLM ID: 1256165 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1432-1041 (Electronic) Linking ISSN: 00316970 NLM ISO Abbreviation: Eur J Clin Pharmacol Subsets: MEDLINE
    • Publication Information:
      Original Publication: Berlin, New York, Springer.
    • Subject Terms:
      Pharmacovigilance*; Anticoagulants/*adverse effects ; Drug Eruptions/*etiology ; Drug Hypersensitivity/*physiopathology ; Eosinophilia/*etiology ; Phenindione/*analogs & derivatives ; Vitamin K/*antagonists & inhibitors; Administration, Oral ; Adult ; Adverse Drug Reaction Reporting Systems ; Aged ; Aged, 80 and over ; Anticoagulants/administration & dosage ; Drug Eruptions/therapy ; Drug Hypersensitivity/diagnosis ; Drug Hypersensitivity/therapy ; Eosinophilia/chemically induced ; Eosinophilia/therapy ; Female ; France ; Humans ; Male ; Middle Aged ; Phenindione/administration & dosage ; Phenindione/adverse effects ; Retrospective Studies ; Severity of Illness Index ; Skin Tests
    • Abstract:
      Purpose: Fluindione is an oral vitamin K antagonist (indanedione derivative) exclusively marketed in France and Luxembourg, known to have immuno-allergic adverse effects such as hepatitis, fever or interstitial nephritis. A few cases of drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with fluindione. The aim of the present study was to investigate fluindione-induced DRESS cases reported in France and to describe their characteristics.
      Methods: We searched for potential cases of DRESS with fluindione reported in the French pharmacovigilance database since 2000.
      Results: Thirty-six cases of DRESS were included and concerned 17 women and 19 men. The mean age was 65 years (median: 68 years, range: 28-95 years). Kidneys and liver were the most frequent organs involved. Thirty-five cases were serious. In 5 cases, the effect was life-threatening. Most of the patients recovered. Fluindione was the only medicine suspected in 26 cases. Skin patch tests, performed in 10 cases, were positive with fluindione in 9 cases.
      Conclusions: Fluindione is not known to be a frequent cause of DRESS. However, the number of reports found is probably underestimated. The seriousness of DRESS, as all immuno-allergic adverse effects, contraindicates fluindione reintroduction. Coumarinic derivatives are the alternatives in patients who need oral anticoagulant treatment.
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    • Accession Number:
      0 (Anticoagulants)
      12001-79-5 (Vitamin K)
      5M7Y6274ZE (Phenindione)
      EQ35YMS20Q (fluindione)
    • Publication Date:
      Date Created: 20110728 Date Completed: 20120504 Latest Revision: 20220419
    • Publication Date:
      20240829
    • Accession Number:
      10.1007/s00228-011-1101-9
    • Accession Number:
      21792562