| アブストラクト | Clozapine-related drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome is a rare adverse reaction. We aimed to screen a large pharmacovigilance database to identify clozapine-related DRESS cases, even if otherwise reported and provide a clinical overview. We screened spontaneous reports of clozapine-related DRESS syndrome in EudraVigilance database applying the European Registry on Severe Cutaneous Adverse Drug Reactions (RegiSCAR) criteria and scores to identify probable/definite DRESS syndrome cases. Clinical and demographic characteristics of included cases were provided and associations between RegiSCAR scores, and time to develop/recover DRESS were assessed. In a total of 262,146 adverse drug reactions reports for 75,190 clozapine-treated patients, 596 cases fulfilled RegiSCAR criteria; ultimately, 51 cases were rated as probable/definite DRESS according to RegiSCAR scores, of which 4 were previously published as case reports. The mean age of patients was 41.06 years (43.1% females), with 13 patients (25.5%) receiving reported co-medication with other DRESS culprit drugs. Median time between clozapine initiation and DRESS symptoms was 25 days. Clozapine dose was associated with days to develop symptoms (Spearman's rho 0.40, p = 0.03). Organ involvement was reported in all cases followed by fever (n = 49; 96.1%) and eosinophilia (n = 47; 92.2%). Treatment involved clozapine discontinuation for 37 patients (72.5%), while 3.9% (n = 2) of cases ended fatally. Clozapine rechallenge was undertaken in 25 patients (49.0%). The screening of the EudraVigilance database revealed 47 novel clozapine-related DRESS cases, and only one was originally reported as DRESS. Clozapine-related DRESS may occur with clozapine monotherapy not only during dose titration, but also during maintenance treatment. |
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| 組織名 | Psychiatry Unit, Department of Health Sciences, University Magna Graecia of;Catanzaro, Catanzaro, 88100, Italy; Department of Psychiatry, Psychotherapy and;Psychosomatics, Hospital of Psychiatry, University of Zurich, Zurich,;Switzerland. Electronic address: defilippisrenato@gmail.com.;The Zucker Hillside Hospital, Psychiatry Research, Northwell Health, Glen Oaks,;New York, USA; Department of Psychiatry, Zucker School of Medicine at;Northwell/Hofstra, Hempstead, NY, USA; Center for Psychiatric Neuroscience,;Feinstein Institute for Medical Research, Manhasset, NY, USA.;Department of Psychiatry, Psychotherapy and Psychosomatics, Hospital of;Psychiatry, University of Zurich, Zurich, Switzerland.;Department of Clinical and Experimental Medicine, University of Messina, 98125,;Messina, Italy.;Department of Health Sciences, University Magna Graecia of Catanzaro, Catanzaro,;Italyh.;Mental Health Research Center, Eastern State Hospital, Lexington, KY, USA;;Biomedical Research Centre in Mental Health Net (CIBERSAM), Santiago Apostol;Hospital, University of the Basque Country, Vitoria, Spain.;Catanzaro, Catanzaro, 88100, Italy.;Psychiatry, University of Zurich, Zurich, Switzerland; The Zucker Hillside;Hospital, Psychiatry Research, Northwell Health, Glen Oaks, New York, USA;;Department of Psychiatry, Zucker School of Medicine at Northwell/Hofstra,;Hempstead, NY, USA. |
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