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dc.rights.licenseopenen_US
dc.contributor.authorDE LEON, Jose
dc.contributor.authorARROJO-ROMERO, Manuel
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorVERDOUX, Helene
dc.contributor.authorRUAN, Can-Jun
dc.contributor.authorSCHORETSANITIS, Georgios
dc.contributor.authorROHDE, Christopher
dc.contributor.authorCOHEN, Dan
dc.contributor.authorSCHULTE, Peter F. J.
dc.contributor.authorKIM, Se Hyun
dc.contributor.authorCOTES, Robert O.
dc.contributor.authorLEUNG, Jonathan G.
dc.contributor.authorOTSUKA, Yuji
dc.contributor.authorKIRILOCHEV, Oleg O.
dc.contributor.authorBAPTISTA, Trino
dc.contributor.authorGROVER, Sandeep
dc.contributor.authorEVERY-PALMER, Susanna
dc.contributor.authorCLARK, Scott R.
dc.contributor.authorMCGRANE, Ian R.
dc.contributor.authorMOTUCA, Mariano
dc.contributor.authorOLMOS, Ismael
dc.contributor.authorWILKOWSKA, Alina
dc.contributor.authorSAGUD, Marina
dc.contributor.authorANIL YAGCIOGLU, A. Elif
dc.contributor.authorRISTIC, Dragana Ignjatovic
dc.contributor.authorLAZARY, Judit
dc.contributor.authorSANZ, Emilio J.
dc.contributor.authorDE LAS CUEVAS, Carlos
dc.date.accessioned2023-06-22T13:32:14Z
dc.date.available2023-06-22T13:32:14Z
dc.date.issued2023-05
dc.identifier.issn1533-712X (Electronic) 0271-0749 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/182772
dc.description.abstractEnPURPOSE/BACKGROUND: A recent article in this journal presented a US perspective regarding the modernization of clozapine prescription and proposed an escape from the long shadow cast by agranulocytosis. METHODS: Here, an international group of collaborators discusses a point of view complementary to the US view by focusing on worldwide outcomes of clozapine usage that may be uneven in terms of frequency of clozapine adverse drug reactions. FINDINGS/RESULTS: Studies from the Scandinavian national registries (Finland and Denmark) did not find increased mortality in clozapine patients or any clear evidence of the alleged toxicity of clozapine. Data on clozapine-associated fatal outcomes were obtained from 2 recently published pharmacovigilance studies and from the UK pharmacovigilance database. A pharmacovigilance study focused on physician reports to assess worldwide lethality of drugs from 2010 to 2019 found 968 clozapine-associated fatal outcomes in the United Kingdom. Moreover, the United Kingdom accounted for 55% (968 of 1761) of worldwide and 90% (968 of 1073) of European fatal clozapine-associated outcomes. In a pharmacovigilance study from the UK database (from 2008 to 2017), clozapine was associated with 383 fatal outcomes/year including all reports from physicians and nonphysicians. From 2018 to 2021, UK clozapine-associated fatal outcomes increased to 440/year. IMPLICATIONS/CONCLUSIONS: The interpretation of fatal outcomes in each country using pharmacovigilance databases is limited and only allows gross comparisons; even with those limitations, the UK data seem concerning. Pneumonia and myocarditis may be more important than agranulocytosis in explaining the uneven distribution of fatal outcomes in clozapine patients across countries.
dc.language.isoENen_US
dc.subject.enClozapine/adverse effects
dc.subject.enClozapine/administration and dosage
dc.subject.enClozapine/metabolism
dc.subject.enClozapine/therapeutic use
dc.subject.enClozapine/toxicity
dc.subject.enCOVID-19
dc.subject.enDrug labeling
dc.subject.enInfection
dc.subject.enInflammation
dc.subject.enMortality/drug effects
dc.subject.enPneumonia
dc.subject.enSchizophrenia
dc.subject.enSex
dc.subject.enSmoking
dc.title.enEscaping the Long Shadow Cast by Agranulocytosis: Reflections on Clozapine Pharmacovigilance Focused on the United Kingdom
dc.title.alternativeJ Clin Psychopharmacolen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1097/jcp.0000000000001678en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed37068034en_US
bordeaux.journalJournal of Clinical Psychopharmacologyen_US
bordeaux.page239-245en_US
bordeaux.volume43en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue3en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamAHEAD_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-04137921
hal.version1
hal.date.transferred2023-06-22T13:32:34Z
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
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