{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,28]],"date-time":"2026-02-28T12:21:26Z","timestamp":1772281286996,"version":"3.50.1"},"reference-count":56,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2024,12,18]],"date-time":"2024-12-18T00:00:00Z","timestamp":1734480000000},"content-version":"vor","delay-in-days":17,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Evidence Based Medicine"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>This study aims to investigate the occurrence of adverse events associated with topiramate by analyzing data from the FDA Adverse Event Reporting System. The goal is to provide a basis for the safe clinical use of topiramate.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Adverse event data from the FDA Adverse Event Reporting System, from its inception through the first quarter of 2024, were extracted. Signal detection was conducted using three methods: the reporting odds ratio, the medicines and healthcare products regulatory agency method, and the Bayesian confidence propagation neural network. Adverse events were statistically analyzed according to the preferred term and system organ class classifications from the Medical Dictionary for Regulatory Activities version 27.0. Positive signals were then compared against the drug label and the Important Medical Event list.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 12,168 adverse event reports involving topiramate as the primary suspect were analyzed, resulting in the extraction of 244 positive signals across 15 system organ classes. Among these, 21 signals were identified as serious adverse reactions not included in the drug label, encompassing 5 system organ classes. Notable signals included hypospadias, spina bifida, abortion spontaneous, renal tubular dysfunction, uveitis, retinal detachment, and choroidal effusion. Additionally, signals such as osmotic demyelination syndrome and Arnold\u2010Chiari malformation were identified as requiring further monitoring.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This study identified several unexpected and serious adverse reaction signals that align with previously reported cases. These findings underscore the need for ongoing study, focused attention, and vigilant monitoring during the clinical use of topiramate.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jebm.12667","type":"journal-article","created":{"date-parts":[[2024,12,18]],"date-time":"2024-12-18T11:34:53Z","timestamp":1734521693000},"page":"795-807","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Postmarketing Safety Surveillance of Topiramate: A Signal Detection and Analysis Study Based on the FDA Adverse Event Reporting System Database"],"prefix":"10.1111","volume":"17","author":[{"given":"Kai","family":"Lin","sequence":"first","affiliation":[{"name":"School of International Pharmaceutical Business China Pharmaceutical University  Nanjing Jiangsu China"},{"name":"Hainan Center for Drug and Medical Device Evaluation and Service Hainan Medical Products Administration  Haikou Hainan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mengjiao","family":"He","sequence":"additional","affiliation":[{"name":"School of International Pharmaceutical Business China Pharmaceutical University  Nanjing Jiangsu China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0957-4193","authenticated-orcid":false,"given":"Zuoqi","family":"Ding","sequence":"additional","affiliation":[{"name":"School of International Pharmaceutical Business China Pharmaceutical University  Nanjing Jiangsu China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,12,18]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"WHO.Epilepsy2024 https:\/\/www.who.int\/news\u2010room\/fact\u2010sheets\/detail\/epilepsy."},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/WCO.0000000000000803"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.neuropharm.2019.107790"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(20)30035-1"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.seizure.2022.03.024"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1167.2005.00326.x"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40263-023-01013-8"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-023-02586-y"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.1267"},{"issue":"11","key":"e_1_2_9_11_1","first-page":"84","article-title":"Comparison of the Efficacy and Adverse Effects of Topiramate and Levetiracetam Monotherapy in Children With Epilepsy","volume":"20","author":"Qi H. X.","year":"2017","journal-title":"Chinese Journal of Practical Neurology Diseases"},{"issue":"4","key":"e_1_2_9_12_1","first-page":"365","article-title":"A Comparative Study of the Efficacy of Topiramate and Levetiracetam in the Treatment of Epilepsy in Children With Epilepsy","volume":"42","author":"Yang L. N.","year":"2021","journal-title":"Medicine and Pharmacy of Yunnan"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1177\/03331024231156922"},{"issue":"4","key":"e_1_2_9_14_1","first-page":"872","article-title":"An Analysis of the Safety Evaluation of Topiramate in the Treatment of Epilepsy","volume":"35","author":"Liu L. F.","year":"2022","journal-title":"Heilongjiang Pharmaceutical"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40801-016-0078-1"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.3402\/jchimp.v6.30510"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2024.1333662"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1080\/14740338.2024.2410436"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/andr.13533"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2024.1338902"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.intimp.2020.106601"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.677"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.668"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1093\/bib\/bbab347"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2024.1251961"},{"key":"e_1_2_9_26_1","unstructured":"EMA.EudraVigilance system overview2016 https:\/\/www.ema.europa.eu\/en\/human\u2010regulatory\u2010overview\/research\u2010development\/pharmacovigilance\u2010research\u2010development\/eudravigilance."},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2020.04.044"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1097\/ICB.0000000000001538"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.4103\/ijo.IJO_245_19"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pediatrneurol.2007.03.001"},{"key":"e_1_2_9_31_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2021.06.045"},{"key":"e_1_2_9_32_1","doi-asserted-by":"publisher","DOI":"10.1159\/000049841"},{"key":"e_1_2_9_33_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.yebeh.2023.109219"},{"issue":"9","key":"e_1_2_9_34_1","first-page":"457","article-title":"Diagnosis of Renal Tubular Dysfunction Diseases","volume":"20","author":"Zhang Q.","year":"1989","journal-title":"Journal of New Medicine"},{"issue":"11","key":"e_1_2_9_35_1","first-page":"1368","article-title":"Progress in the Study of the Etiology and Pathogenesis of Spina Bifida","volume":"35","author":"Zhu H.","year":"2021","journal-title":"Chinese Journal of Reparative and Reconstructive Surgery"},{"key":"e_1_2_9_36_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(13)70110-8"},{"key":"e_1_2_9_37_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200011303432204"},{"issue":"9","key":"e_1_2_9_38_1","first-page":"889","article-title":"Guidelines for the Management of Adverse Reactions to Antiepileptic Seizure Medications (2023)","volume":"25","author":"Peng J. C. C.","year":"2023","journal-title":"Chinese Journal of Contemporary Pediatrics"},{"issue":"7","key":"e_1_2_9_39_1","first-page":"1243","article-title":"Management of Spontaneous Abortion","volume":"72","author":"Griebel C. P.","year":"2005","journal-title":"American Family Physician"},{"key":"e_1_2_9_40_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.reprotox.2008.03.001"},{"key":"e_1_2_9_41_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eplepsyres.2018.07.016"},{"key":"e_1_2_9_42_1","doi-asserted-by":"publisher","DOI":"10.1503\/cmaj.191337"},{"key":"e_1_2_9_43_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajoc.2017.05.005"},{"key":"e_1_2_9_44_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.oftal.2019.07.014"},{"key":"e_1_2_9_45_1","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-199717030-00005"},{"issue":"2","key":"e_1_2_9_46_1","first-page":"314","article-title":"Review of Topiramate and Uveitis Induced by Topiramate","volume":"15","author":"Qi C.","year":"2020","journal-title":"Chinese Medicine"},{"key":"e_1_2_9_47_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0034-1368282"},{"key":"e_1_2_9_48_1","doi-asserted-by":"publisher","DOI":"10.2147\/OPTH.S104847"},{"key":"e_1_2_9_49_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12886-021-02050-x"},{"key":"e_1_2_9_50_1","doi-asserted-by":"publisher","DOI":"10.1111\/ene.12571"},{"issue":"8","key":"e_1_2_9_51_1","article-title":"Monotherapy Treatment of Epilepsy in Pregnancy: Congenital Malformation Outcomes in the Child","volume":"2023","author":"Bromley R.","year":"2023","journal-title":"The Cochrane Database of Systematic Reviews"},{"key":"e_1_2_9_52_1","unstructured":"F. D. A FDALabel2022 https:\/\/nctr\u2010crs.fda.gov\/fdalabel\/ui\/search."},{"issue":"3","key":"e_1_2_9_53_1","first-page":"183","article-title":"Oligohydramnios: Problems and Treatment","volume":"17","author":"McCurdy C. M.","year":"1993","journal-title":"Seminars in Perinatology"},{"key":"e_1_2_9_54_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2018.07.037"},{"key":"e_1_2_9_55_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.mjafi.2012.07.019"},{"issue":"8","key":"e_1_2_9_56_1","article-title":"The Ophthalmic Side Effects of Topiramate: A Review","volume":"14","author":"Mechrgui M.","year":"2022","journal-title":"Cureus"},{"key":"e_1_2_9_57_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2024.1290975"}],"container-title":["Journal of Evidence-Based Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jebm.12667","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,12,30]],"date-time":"2024-12-30T16:39:53Z","timestamp":1735576793000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jebm.12667"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,12]]},"references-count":56,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2024,12]]}},"alternative-id":["10.1111\/jebm.12667"],"URL":"https:\/\/doi.org\/10.1111\/jebm.12667","archive":["Portico"],"relation":{},"ISSN":["1756-5383","1756-5391"],"issn-type":[{"value":"1756-5383","type":"print"},{"value":"1756-5391","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,12]]},"assertion":[{"value":"2024-09-29","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-12-09","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-12-18","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}