Is uveitis associated with topiramate use? A cumulative review

Jeffrey L Goldberg,1 Amy G Lau,2 Bo Fan,2 Lisa Ford,3 Howard E Greenberg3 1Byers Eye Institute, Stanford University, Palo Alto, CA, 2Janssen Research & Development, LLC, Horsham, PA, 3Janssen Research & Development, LLC, Titusville, NJ, USA Abstract: Occasional reports of uveitis f...

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Autores principales:	Goldberg JL, Lau AG, Fan B, Ford L, Greenberg HE
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2016
Materias:	topiramate uveitis acute angle-closure glaucoma drug safety Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/d58fed092bc24d6c89128bd3352e8491
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spelling	oai:doaj.org-article:d58fed092bc24d6c89128bd3352e84912021-12-02T00:22:02ZIs uveitis associated with topiramate use? A cumulative review1177-5483https://doaj.org/article/d58fed092bc24d6c89128bd3352e84912016-08-01T00:00:00Zhttps://www.dovepress.com/is-uveitis-associated-with-topiramate-use-a-cumulative-review-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Jeffrey L Goldberg,1 Amy G Lau,2 Bo Fan,2 Lisa Ford,3 Howard E Greenberg3 1Byers Eye Institute, Stanford University, Palo Alto, CA, 2Janssen Research & Development, LLC, Horsham, PA, 3Janssen Research & Development, LLC, Titusville, NJ, USA Abstract: Occasional reports of uveitis following topiramate use necessitated an investigation of relevant cases from safety databases and published biomedical literature. Data mining of the Food and Drug Administration Adverse Event Reporting System and cumulative review of cases from the global safety database (sponsor database) and published literature were conducted to assess association between topiramate use and uveitis. The Food and Drug Administration Adverse Event Reporting System search identified disproportional reporting of uveitis (n=23) and related terms (choroidal detachment, n=25; iridocyclitis, n=17). The postmarketing reporting frequency of uveitis and related events from the global safety database and based on an estimated topiramate exposure of 11,185,740 person-years from launch to April 2015 was 0.38 per 100,000 person-years and assigned as very rare. A total of 14 potential uveitis cases were identified from the cumulative review. Seven of these 14 cases were complicated by inadequate documentation, appearance of uveitic signs following drug withdrawal, or concurrent use of other sulfonamides. In acute angle-closure glaucoma and uveal effusions cases, insufficient evidence for underlying inflammation suggested that uveitis was not a component. Only seven of 14 cases were well documented, potentially topiramate-associated uveitis cases. Uveitis may occur in the setting of topiramate use only in very rare instances. Current evidence did not reveal a dose- or duration-dependent relationship between uveitis and topiramate use. Keywords: topiramate, uveitis, acute angle-closure glaucoma, drug safety, Food and Drug Administration Adverse Event Reporting System, postmarketing Goldberg JLLau AGFan BFord LGreenberg HEDove Medical Pressarticletopiramateuveitisacute angle-closure glaucomadrug safetyOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2016, Iss Issue 1, Pp 1467-1470 (2016)
institution	DOAJ
collection	DOAJ
language	EN
topic	topiramate uveitis acute angle-closure glaucoma drug safety Ophthalmology RE1-994
spellingShingle	topiramate uveitis acute angle-closure glaucoma drug safety Ophthalmology RE1-994 Goldberg JL Lau AG Fan B Ford L Greenberg HE Is uveitis associated with topiramate use? A cumulative review
description	Jeffrey L Goldberg,1 Amy G Lau,2 Bo Fan,2 Lisa Ford,3 Howard E Greenberg3 1Byers Eye Institute, Stanford University, Palo Alto, CA, 2Janssen Research & Development, LLC, Horsham, PA, 3Janssen Research & Development, LLC, Titusville, NJ, USA Abstract: Occasional reports of uveitis following topiramate use necessitated an investigation of relevant cases from safety databases and published biomedical literature. Data mining of the Food and Drug Administration Adverse Event Reporting System and cumulative review of cases from the global safety database (sponsor database) and published literature were conducted to assess association between topiramate use and uveitis. The Food and Drug Administration Adverse Event Reporting System search identified disproportional reporting of uveitis (n=23) and related terms (choroidal detachment, n=25; iridocyclitis, n=17). The postmarketing reporting frequency of uveitis and related events from the global safety database and based on an estimated topiramate exposure of 11,185,740 person-years from launch to April 2015 was 0.38 per 100,000 person-years and assigned as very rare. A total of 14 potential uveitis cases were identified from the cumulative review. Seven of these 14 cases were complicated by inadequate documentation, appearance of uveitic signs following drug withdrawal, or concurrent use of other sulfonamides. In acute angle-closure glaucoma and uveal effusions cases, insufficient evidence for underlying inflammation suggested that uveitis was not a component. Only seven of 14 cases were well documented, potentially topiramate-associated uveitis cases. Uveitis may occur in the setting of topiramate use only in very rare instances. Current evidence did not reveal a dose- or duration-dependent relationship between uveitis and topiramate use. Keywords: topiramate, uveitis, acute angle-closure glaucoma, drug safety, Food and Drug Administration Adverse Event Reporting System, postmarketing
format	article
author	Goldberg JL Lau AG Fan B Ford L Greenberg HE
author_facet	Goldberg JL Lau AG Fan B Ford L Greenberg HE
author_sort	Goldberg JL
title	Is uveitis associated with topiramate use? A cumulative review
title_short	Is uveitis associated with topiramate use? A cumulative review
title_full	Is uveitis associated with topiramate use? A cumulative review
title_fullStr	Is uveitis associated with topiramate use? A cumulative review
title_full_unstemmed	Is uveitis associated with topiramate use? A cumulative review
title_sort	is uveitis associated with topiramate use? a cumulative review
publisher	Dove Medical Press
publishDate	2016
url	https://doaj.org/article/d58fed092bc24d6c89128bd3352e8491
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Is uveitis associated with topiramate use? A cumulative review

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