Drug Rash with Eosinophilia and Systemic Symptoms Syndrome and Fluindione

Abstract

Background: Drug Rash with eosinophilia and systemic symptoms (DRESS) syndrome or drug-induced hypersensitivity syndrome is a severe drug reaction. First described in 1996, this syndrome is not included in adverse drug reaction thesaurus. It is thus particularly difficult to identify cases in a pharmacovigilance database. Through a recent performed search, we illustrate possible under-identification of spontaneous reports in a database. Methods: Using the French Pharmacovigilance database, we searched for possible DRESS syndrome cases reported since 2000 with fluindione. As no specific term exists for DRESS syndrome in WHO-ART or MedDRA thesaurus, the search was performed firstly with “hypersensitivity” and “fluindione”, then by analyzing the summary of all cutaneous reports of fluindione for which haematological abnormalities (eosinophilia or presence of atypical lymphocytes) and/or organ involvement were associated. The definition of DRESS syndrome varies according to authors.[1–3] Results: Sixty-five possible DRESS syndrome cases were identified in the database. Among these, DRESS syndrome was mentioned in the summary for 5 case reports and 4 others cases were later identified as published case reports.[4] Among these cases, 58 cases could be considered as DRESS syndrome with the criteria used by Peyriere,[1] 42 with those used by Roujeau[2] and 26 with those used by Boquet.[3] The search performed by using hypersensitivity and fluindione resulted in only 14 cases. Conclusion: Those results show that the number of cases of DRESS syndrome identified is varying with the criteria used. Moreover, we performed our search using the cutaneous system-organ as the term “rash” is a part of the acronym. But, although the most frequent sign, eruption is not present in all cases. As there is variable presentation encompassing a spectrum of clinical features, this syndrome is often neither recognised nor diagnosed. The definition proposed by Roujeau seems to be the most precise to define a drug-induced hypersensitivity. However, the acronym of DRESS is not suitable in cases eruption et/or eosinophilia is lacking. A clear and consensual definition is urgently needed, with a corresponding preferred term for coding: as the DRESS syndrome is a serious adverse drug reaction, with public health consequences, it is necessary to be able to identify spontaneous reports, to render decision-making appropriate when necessary.