{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,15]],"date-time":"2026-08-15T05:35:06Z","timestamp":1786772106338,"version":"build-2736575974"},"reference-count":28,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2026,7,31]],"date-time":"2026-07-31T00:00:00Z","timestamp":1785456000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,7,31]],"date-time":"2026-07-31T00:00:00Z","timestamp":1785456000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["bpspubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacology Res &amp;amp; Perspec"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    The FDA has mandated a Boxed Warning for glatiramer acetate (GA) due to the risk of serious anaphylactic reaction. This study aimed to characterize the reported features of GA\u2010associated anaphylaxis. Data mining was performed using the Reporting Odds Ratio (ROR) in the FDA Adverse Event Reporting System (FAERS) database (Q1 2004\u2013Q1 2025) and the Canadian Vigilance Adverse Reaction (CVAR) database (Q1 1996\u2013Q1 2025). Demographic characteristics, time\u2010to\u2010onset (TTO), and case seriousness were compared using the Mann\u2013Whitney\n                    <jats:italic>U<\/jats:italic>\n                    test or the Chi\u2010squared (\n                    <jats:italic>\u03c7<\/jats:italic>\n                    <jats:sup>2<\/jats:sup>\n                    ) test. In the FAERS database, 9816 reports were identified with 29 significant disproportionality signals. Younger age (\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.01) was significantly associated with a higher proportion of serious reports. The association between GA and anaphylactic AEs remained statistically significant after stratification by age, body weight, sex, and reporter types. Twenty AEs demonstrated significantly higher reporting rates in serious cases (\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.05). Clinical prioritization identified 9 moderate\u2010priority and 20 weak\u2010priority signals. The median TTO was 197\u2009days for moderate\u2010priority signals versus 153\u2009days for weak\u2010priority signals. All signals exhibited early failure\u2010type patterns, indicating that reported anaphylactic events were more frequently observed earlier after treatment initiation than later in treatment. In the CVAR database, 711 reports were identified. A total of 17 PTs overlapped with FAERS, with respiratory arrest uniquely present in CVAR. Three PTs were rated as moderate priority in the CVAR database but weak priority in FAERS. This large\u2010scale pharmacovigilance analysis of the FDA and Canadian databases characterizes the safety signals derived from GA\u2010associated reports of anaphylaxis, providing a hypothesis\u2010generating foundation for future pharmacovigilance validation.\n                  <\/jats:p>","DOI":"10.1002\/prp2.70303","type":"journal-article","created":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T03:53:38Z","timestamp":1785556418000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Reported Characteristics of Anaphylaxis Associated With Glatiramer Acetate: A Pharmacovigilance Analysis of the FDA and Canadian Databases"],"prefix":"10.1002","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-3969-1255","authenticated-orcid":false,"given":"Tailei","family":"Nie","sequence":"first","affiliation":[{"name":"Department of Pharmacy, Affiliated Hospital of Yangzhou University Yangzhou University  Yangzhou Jiangsu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongyu","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Affiliated Hospital of Yangzhou University Yangzhou University  Yangzhou Jiangsu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6539-6673","authenticated-orcid":false,"given":"Chuanxu","family":"Cheng","sequence":"additional","affiliation":[{"name":"Department of Biomedical Engineering Columbia University  New York New York USA"},{"name":"School of Biomedical Sciences and Engineering South China University of Technology  Guangzhou Guangdong China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jian","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutics, School of Pharmacy China Pharmaceutical University  Nanjing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7752-6826","authenticated-orcid":false,"given":"Jiajing","family":"Lu","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Affiliated Hospital of Yangzhou University Yangzhou University  Yangzhou Jiangsu China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,31]]},"reference":[{"key":"e_1_2_12_2_1","unstructured":"The US Food and Drug Administration \u201cFDA Drug Safety Communication \u201d(2025) https:\/\/www.fda.gov\/media\/185208\/download?attachment."},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/ene.13536"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.autrev.2012.09.005"},{"issue":"11","key":"e_1_2_12_5_1","first-page":"S19","article-title":"Selecting a Disease\u2010Modifying Agent as Platform Therapy in the Long\u2010Term Management of Multiple Sclerosis","volume":"63","author":"Stuart W. 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