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dc.contributor.authorChiappini, Stephania
dc.contributor.authorSchifano, Fabrizio
dc.contributor.authorCorkery, John Martin
dc.contributor.authorGuirguis, Amira
dc.date.accessioned2020-02-19T01:18:15Z
dc.date.available2020-02-19T01:18:15Z
dc.date.issued2020-02-16
dc.identifier.citationChiappini , S , Schifano , F , Corkery , J M & Guirguis , A 2020 , ' Focus on clozapine withdrawal- and misuse-related cases, as reported to the European Medicines Agency (EMA) pharmacovigilance database ' , Brain Sciences , vol. 10 , no. 2 , 105 . https://doi.org/10.3390/brainsci10020105
dc.identifier.issn2076-3425
dc.identifier.otherPURE: 19562801
dc.identifier.otherPURE UUID: 6be6498d-45e1-4697-9a48-45f7d67a005e
dc.identifier.otherScopus: 85079641748
dc.identifier.urihttp://hdl.handle.net/2299/22306
dc.description© 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
dc.description.abstractBackground: Clozapine is of high clinical relevance for the management of both treatment-resistant schizophrenia and psychotic disturbances with concurrent drug misuse. Although the molecule presents with a range of well-known side-effects, its discontinuation/withdrawal syndrome has been only anecdotally described. Aims: the 2005–2018 European Medicines Agency (EMA) dataset of Adverse Drug Reactions (ADRs) was analyzed to identify and describe possible clozapine withdrawal-and misuse-/abuse-/dependence-related issues. Method: A descriptive analysis of clozapine-related ADRs was performed when available, data on ADRs’ outcome, dosage, and possible concomitant drug(s) were considered. Results: Out of 11,847 clozapine-related ADRs, some 599 (5.05%) were related to misuse/abuse/dependence/withdrawal issues, including 258 withdrawal-related (43.1%); 241 abuse-related (40.2%); and 80 intentional product misuse-related (13.3%) ADRs. A small number of overdose-and suicide-related ADRs were reported as well. Clozapine was typically (69.2%) identified alone, and most (84.7%) fatalities/high-dosage intake instances were reported in association with a history of substance abuse. Conclusions: Previous suggestions about the possibility of a clozapine discontinuation/withdrawal occurrence are here supported, but further studies are needed. However, the misuse/abuse cases here identified might be difficult to interpret, given the lack of studies highlighting the possible recreational use of clozapine. The high-dosage intake, fatal outcomes and clozapine/polydrug abuse issues reported here may, however, be a reason for concern.en
dc.format.extent18
dc.language.isoeng
dc.relation.ispartofBrain Sciences
dc.rightsOpen
dc.subjectAdverse drug reactions
dc.subjectClozapine
dc.subjectDependence
dc.subjectMisuse
dc.subjectOverdose
dc.subjectWithdrawal
dc.subjectNeuroscience(all)
dc.titleFocus on clozapine withdrawal- and misuse-related cases, as reported to the European Medicines Agency (EMA) pharmacovigilance databaseen
dc.contributor.institutionDepartment of Clinical and Pharmaceutical Sciences
dc.contributor.institutionCentre for Health Services and Clinical Research
dc.contributor.institutionPsychopharmacology, Drug Misuse and Novel Psychoactive Substances Unit
dc.contributor.institutionSchool of Life and Medical Sciences
dc.contributor.institutionCentre for Clinical Practice, Safe Medicines and Drug Misuse Research
dc.contributor.institutionDepartment of Clinical, Pharmaceutical and Biological Science
dc.description.statusPeer reviewed
dc.identifier.urlhttp://www.scopus.com/inward/record.url?scp=85079641748&partnerID=8YFLogxK
dc.relation.schoolSchool of Life and Medical Sciences
dc.description.versiontypeFinal Published version
dcterms.dateAccepted2020-02-16
rioxxterms.versionVoR
rioxxterms.versionofrecordhttps://doi.org/10.3390/brainsci10020105
rioxxterms.licenseref.urihttp://creativecommons.org/licenses/by/4.0/
rioxxterms.typeJournal Article/Review
herts.preservation.rarelyaccessedtrue
herts.rights.accesstypeOpen


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