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dc.contributor.authorSchifano, Nicolo
dc.contributor.authorChiappini, Stefania
dc.contributor.authorCastiglione, Fabio
dc.contributor.authorSalonia, Andrea
dc.contributor.authorSchifano, Fabrizio
dc.date.accessioned2021-01-21T10:30:02Z
dc.date.available2021-01-21T10:30:02Z
dc.date.issued2020-10-09
dc.identifier.citationSchifano , N , Chiappini , S , Castiglione , F , Salonia , A & Schifano , F 2020 , ' Is medicinal ketamine associated with urinary dysfunction issues? Assessment of both the European Medicines Agency (EMA) and the UK Yellow Card Scheme pharmacovigilance database-related reports ' , LUTS: Lower Urinary Tract Symptoms . https://doi.org/10.1111/luts.12355
dc.identifier.issn1757-5672
dc.identifier.otherPURE: 22674302
dc.identifier.otherPURE UUID: 57454a14-6705-4752-a699-050fa2f28453
dc.identifier.urihttp://hdl.handle.net/2299/23721
dc.description© John Wiley & Sons Australia, Ltd. This is the accepted version of the article published in final form at https://doi.org/10.1111/luts.12355
dc.description.abstractObjective - A range of associated urinary dysfunction (KIU) issues have been typically described in ketamine misusers. Conversely, more knowledge is needed in terms of medicinal ketamine-related urological disturbances. since ketamine prescribing is being increasingly considered for a range of medical and psychopathological conditions. Methods - To assess medicinal ketamine-induced uropathy issues, we aimed at analyzing both the 2005-2017 European Medicines Agency (EMA) and the 2006-2018 UK Yellow Card Scheme (YCS) pharmacovigilance databases. Results - A total number (e.g., all categories) of 11,632 EMA ketamine-related adverse drug reaction (ADR) reports were here identified. Out of these, some 9,971 ADRs (e.g., 85.7% of the total) were judged as ‘suspect’ and were here analyzed. Some 1,758 ADRs (17.7% of 9,971, corresponding to 194 individual patients) referred to urological issues, relating to either kidney/ureter (922 ADRs) or bladder/urethra (837 ADRs). Ketamine was the sole drug administered in 156/194 (80.4%) cases/patients. Although most cases occurred in the 1 month-1 year time frame following the start of ketamine prescribing, in 30 cases the ADR occurred within 48 hours. Most ADR-related cases resolved, although both sequelae (18 cases) and fatalities (79/1,758; 4.5%) were recorded. Overall, YCS data were consistent with EMA findings, with some 50/217 (23%) ADRs referring to renal/urinary disorders. Conclusions - Current data may only represent a gross underestimate of the KIU real prevalence issues. It is here suggested that chronic treatment involving higher doses/repeated exposure to ketamine be restricted to the context of controlled trials or clinical audits.en
dc.language.isoeng
dc.relation.ispartofLUTS: Lower Urinary Tract Symptoms
dc.subjectLUTS
dc.subjectdrug abuse
dc.subjectKetamine
dc.subjectketamine uropathy
dc.subjectlower urinary tract dysfunction
dc.titleIs medicinal ketamine associated with urinary dysfunction issues? Assessment of both the European Medicines Agency (EMA) and the UK Yellow Card Scheme pharmacovigilance database-related reportsen
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.institutionDepartment of Clinical, Pharmaceutical and Biological Science
dc.description.statusPeer reviewed
dc.date.embargoedUntil2021-09-10
rioxxterms.versionAM
rioxxterms.versionofrecordhttps://doi.org/10.1111/luts.12355
rioxxterms.typeJournal Article/Review


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