dc.contributor.author | Chiappini, Stephania | |
dc.contributor.author | Schifano, Fabrizio | |
dc.contributor.author | Corkery, John Martin | |
dc.contributor.author | Guirguis, Amira | |
dc.date.accessioned | 2020-02-19T01:18:15Z | |
dc.date.available | 2020-02-19T01:18:15Z | |
dc.date.issued | 2020-02-16 | |
dc.identifier.citation | Chiappini , 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.issn | 2076-3425 | |
dc.identifier.uri | http://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.abstract | Background: 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.extent | 18 | |
dc.format.extent | 357783 | |
dc.language.iso | eng | |
dc.relation.ispartof | Brain Sciences | |
dc.subject | Adverse drug reactions | |
dc.subject | Clozapine | |
dc.subject | Dependence | |
dc.subject | Misuse | |
dc.subject | Overdose | |
dc.subject | Withdrawal | |
dc.subject | General Neuroscience | |
dc.title | Focus on clozapine withdrawal- and misuse-related cases, as reported to the European Medicines Agency (EMA) pharmacovigilance database | en |
dc.contributor.institution | Department of Clinical and Pharmaceutical Sciences | |
dc.contributor.institution | Centre for Health Services and Clinical Research | |
dc.contributor.institution | Psychopharmacology, Drug Misuse and Novel Psychoactive Substances Unit | |
dc.contributor.institution | School of Life and Medical Sciences | |
dc.contributor.institution | Centre for Clinical Practice, Safe Medicines and Drug Misuse Research | |
dc.contributor.institution | Department of Clinical, Pharmaceutical and Biological Science | |
dc.description.status | Peer reviewed | |
dc.identifier.url | http://www.scopus.com/inward/record.url?scp=85079641748&partnerID=8YFLogxK | |
rioxxterms.versionofrecord | 10.3390/brainsci10020105 | |
rioxxterms.type | Journal Article/Review | |
herts.preservation.rarelyaccessed | true | |