dc.contributor.author | Schifano, Nicolo | |
dc.contributor.author | Chiappini, Stefania | |
dc.contributor.author | Castiglione, Fabio | |
dc.contributor.author | Salonia, Andrea | |
dc.contributor.author | Schifano, Fabrizio | |
dc.date.accessioned | 2021-01-22T15:25:20Z | |
dc.date.available | 2021-01-22T15:25:20Z | |
dc.date.issued | 2020-10-09 | |
dc.identifier.citation | Schifano , 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 , vol. 13 , no. 2 , pp. 230-237 . https://doi.org/10.1111/luts.12355 | |
dc.identifier.issn | 1757-5672 | |
dc.identifier.uri | http://hdl.handle.net/2299/23734 | |
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. Volume & Issue number allocated April 2021. | |
dc.description.abstract | Objective: A range of ketamine-induced uropathy (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 KIU 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 (eg, all categories) of 11 632 EMA ketamine-related adverse drug reaction (ADR) reports were here identified. Out of these, some 9971 ADRs (eg, 85.7% of the total) were judged as “suspect” and were here analyzed. Some 1758 ADRs (17.7% of 9971, 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 (79/1758; 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.format.extent | 350138 | |
dc.language.iso | eng | |
dc.relation.ispartof | LUTS: Lower Urinary Tract Symptoms | |
dc.subject | LUTS | |
dc.subject | drug abuse | |
dc.subject | ketamine | |
dc.subject | ketamine uropathy | |
dc.subject | lower urinary tract dysfunction | |
dc.subject | Neurology | |
dc.subject | Urology | |
dc.title | 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 | 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 | Department of Clinical, Pharmaceutical and Biological Science | |
dc.description.status | Peer reviewed | |
dc.date.embargoedUntil | 2021-09-10 | |
dc.identifier.url | http://www.scopus.com/inward/record.url?scp=85092481339&partnerID=8YFLogxK | |
rioxxterms.versionofrecord | 10.1111/luts.12355 | |
rioxxterms.type | Journal Article/Review | |
herts.preservation.rarelyaccessed | true | |