Antipsychotic-Related DRESS Syndrome: Analysis of Individual Case Safety Reports of the WHO Pharmacovigilance Database

Renato de Filippis (), John M. Kane (), Elena Arzenton (), Ugo Moretti (), Emanuel Raschi (), Gianluca Trifirò (), Corrado Barbui (), Pasquale De Fazio (), Chiara Gastaldon () and Georgios Schoretsanitis ()
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Renato de Filippis: University Magna Graecia of Catanzaro
John M. Kane: The Zucker Hillside Hospital, Psychiatry Research, Northwell Health
Elena Arzenton: University of Verona
Ugo Moretti: University of Verona
Emanuel Raschi: University of Bologna
Gianluca Trifirò: University of Verona
Corrado Barbui: University of Verona
Pasquale De Fazio: University Magna Graecia of Catanzaro
Chiara Gastaldon: University of Verona
Georgios Schoretsanitis: The Zucker Hillside Hospital, Psychiatry Research, Northwell Health

Drug Safety, 2024, vol. 47, issue 8, No 3, 745-757

Abstract: Abstract Introduction Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome is gaining attention in pharmacovigilance, but its association with antipsychotics, other than clozapine, is still unclear. Methods We conducted a case/non-case study with disproportionality analysis based on the World Health Organization (WHO) global spontaneous reporting database, VigiBase®. We analyzed individual case safety reports of DRESS syndrome related to antipsychotics compared to (1) all other medications in VigiBase®, (2) carbamazepine (a known positive control), and (3) within classes (typical/atypical) of antipsychotics. We calculated reporting odds ratio (ROR) and Bayesian information component (IC), with 95% confidence intervals (CIs). Disproportionate reporting was prioritized based on clinical importance, according to predefined criteria. Additionally, we compared characteristics of patients reporting with serious/non-serious reactions. Results A total of 1534 reports describing DRESS syndrome for 19 antipsychotics were identified. The ROR for antipsychotics as a class as compared to all other medications was 1.0 (95% CI 0.9–1.1). We found disproportionate reporting for clozapine (ROR 2.3, 95% CI 2.1–2.5; IC 1.2, 95% CI 1.1–1.3), cyamemazine (ROR 2.3, 95% CI 1.5–3.5; IC 1.2, 95% CI 0.5–1.7), and chlorpromazine (ROR 1.5, 95% CI 1.1–2.1; IC 0.6, 95% CI 0.1–1.0). We found 35.7% of cases with co-reported anticonvulsants, and 25% with multiple concurrent antipsychotics in serious compared to 8.6% in non-serious cases (p = 0.03). Fatal cases were 164 (10.7%). Conclusions Apart from the expected association with clozapine, chlorpromazine and cyamemazine (sharing an aromatic heteropolycyclic molecular structure) emerged with a higher-than-expected reporting of DRESS. Better knowledge of the antipsychotic-related DRESS syndrome should increase clinicians’ awareness leading to safer prescribing of antipsychotics.

Date: 2024
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DOI: 10.1007/s40264-024-01431-7

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