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

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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https://hal-unilim.archives-ouvertes.fr/hal-00713311
Contributeur : Jean-Christophe Daviet <>
Soumis le : vendredi 29 juin 2012 - 18:26:47
Dernière modification le : vendredi 23 mars 2018 - 14:04:04

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Amélie Daveluy, Brigitte Milpied, Annick Barbaud, Bénédicte Lebrun-Vignes, Aurore Gouraud, et al.. Fluindione and drug reaction with eosinophilia and systemic symptoms: an unrecognised adverse effect?. European Journal of Clinical Pharmacology, Springer Verlag, 2012, 68 (1), pp.101-5. ⟨10.1007/s00228-011-1101-9⟩. ⟨hal-00713311⟩

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