{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T23:27:55Z","timestamp":1763767675797,"version":"3.40.5"},"reference-count":31,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2023,8,26]],"date-time":"2023-08-26T00:00:00Z","timestamp":1693008000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Epileptic Disorders"],"published-print":{"date-parts":[[2023,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>Eslicarbazepine acetate (ESL) is a once\u2010daily oral antiseizure medication. Its safety and tolerability from clinical trials have been mostly confirmed by real\u2010world data. The main purpose of this report is to provide an overview of the safety profile of ESL in the United Kingdom (UK) and Republic of Ireland (ROI).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Safety data were obtained from the UK and ROI post\u2010marketing sources (October 2009\u2013April 2022) by the marketing authorization holder. All individual reports were included in the Argus Safety\u2122 database. All adverse events (AEs) were coded using MedDRA\u00ae version 24.1. Only valid cases (meeting the minimum pharmacovigilance reporting requirements) were included.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>During 13\u2009years of ESL marketing, with cumulative estimated exposure of 2\u2009210\u2009395 patients\u2010years, 183 reports were received. A total of 402 AEs were reported for the 155 valid reports. The most common reported AEs (\u22656% of total reported), per system organ class (SOC), were: nervous system disorders (23.4%), injury, poisoning, and procedural complications (18.9%), general disorders and administration site conditions (12.9%), psychiatric disorders (12.7%) and gastrointestinal disorders (6.7%). The most frequently reported (\u22652% of total reported) AEs were: seizure (4.5%), hyponatremia (4.2%), dizziness (2.7%), rash, fatigue (2.5% each), and somnolence (2.0%). Twenty\u2010six percent of events were classified as serious (including six fatal cases).<\/jats:p><\/jats:sec><jats:sec><jats:title>Significance<\/jats:title><jats:p>The current analysis supports the known safety profile of ESL, as generally well\u2010tolerated with most AEs being non\u2010serious. The most common AEs were considered either expected according to the disease itself or to the reference safety information. ESL continues to be a relevant medication in the treatment of partial (focal\u2010onset) epilepsy, as also confirmed by the 2022 NICE guidelines.<\/jats:p><\/jats:sec>","DOI":"10.1002\/epd2.20146","type":"journal-article","created":{"date-parts":[[2023,8,16]],"date-time":"2023-08-16T16:29:10Z","timestamp":1692203350000},"page":"803-814","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Thirteen\u2009years of experience with eslicarbazepine acetate in the United Kingdom and Republic of Ireland: A safety perspective"],"prefix":"10.1002","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0009-0002-4713-8579","authenticated-orcid":false,"given":"Lu\u00eds","family":"Guedes","sequence":"first","affiliation":[{"name":"BIAL\u2010Portela &amp; C\u00aa., S.A.  S\u00e3o Mamede do Coronado Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mariana","family":"Vieira","sequence":"additional","affiliation":[{"name":"BIAL\u2010Portela &amp; C\u00aa., S.A.  S\u00e3o Mamede do Coronado Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helena","family":"Gama","sequence":"additional","affiliation":[{"name":"BIAL\u2010Portela &amp; C\u00aa., S.A.  S\u00e3o Mamede do Coronado Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Magano","sequence":"additional","affiliation":[{"name":"BIAL\u2010Portela &amp; C\u00aa., S.A.  S\u00e3o Mamede do Coronado Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria","family":"Fernandes","sequence":"additional","affiliation":[{"name":"BIAL\u2010Portela &amp; C\u00aa., S.A.  S\u00e3o Mamede do Coronado Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patricia","family":"Calero","sequence":"additional","affiliation":[{"name":"Laboratorios Bial S.A.  Madrid Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-7242-5502","authenticated-orcid":false,"given":"Valentina","family":"Di\u00a0Foggia","sequence":"additional","affiliation":[{"name":"Bial UK Pharma Ltd  Windsor UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,8,26]]},"reference":[{"key":"e_1_2_10_2_1","unstructured":"European Medicines Agency.Zebinix (eslicarbazepine acetate): EU summary of product characteristics.2022[cited 2022 Sep 1]. Available from:https:\/\/www.ema.europa.eu\/en\/documents\/product\u2010information\/zebinix\u2010epar\u2010product\u2010information_en.pdf"},{"key":"e_1_2_10_3_1","unstructured":"Medicines and Healthcare Products Regulatory Agency.Zebinix (eslicarbazepine acetate): summary of product characteristics.2022[cited 2022 Sep 5]. 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