{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T23:39:17Z","timestamp":1777937957017,"version":"3.51.4"},"reference-count":24,"publisher":"SAGE Publications","issue":"14","license":[{"start":{"date-parts":[[2025,10,26]],"date-time":"2025-10-26T00:00:00Z","timestamp":1761436800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Mult Scler"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Immediate post-injection reactions were commonly observed in registrational trials of glatiramer acetate (GA) for the treatment of multiple sclerosis. Immediate post-injection reactions, characterized by a constellation of symptoms that may occur immediately after injection, can involve signs and symptoms that resemble those of anaphylaxis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>The objective of this study is to describe cases of serious anaphylaxis that supported the postmarketing safety labeling change for GA in the United States.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>A review of the Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) database and published medical literature was conducted.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>We identified 82 cases of anaphylaxis with GA in FAERS and the medical literature. Six cases reported a fatal outcome (3 anaphylaxis, 3 sudden death). These cases reported anaphylaxis occurring in patients 1\u2009week to 72\u2009months following initiation of GA, including 19 cases that reported anaphylaxis more than 1\u2009year following initiation of GA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>As these reactions have implications for prescribing decisions and patient management, the FDA issued a labeling change notification to update the WARNINGS AND PRECAUTIONS section and add a BOXED WARNING to the United States prescribing information for GA. A Drug Safety Communication was also issued to inform the public about this update.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/13524585251382397","type":"journal-article","created":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T04:55:20Z","timestamp":1761540920000},"page":"1664-1671","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Anaphylaxis and glatiramer acetate"],"prefix":"10.1177","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-1556-9861","authenticated-orcid":false,"given":"Tiffany B","family":"Kim","sequence":"first","affiliation":[{"name":"Division of Pharmacovigilance I, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food &amp; Drug Administration, Silver Spring, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jenni Yoon","family":"Lee","sequence":"additional","affiliation":[{"name":"Division of Pharmacovigilance I, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food &amp; Drug Administration, Silver Spring, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Allen","family":"Brinker","sequence":"additional","affiliation":[{"name":"Division of Pharmacovigilance I, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food &amp; Drug Administration, Silver Spring, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6681-562X","authenticated-orcid":false,"given":"Paul R","family":"Lee","sequence":"additional","affiliation":[{"name":"Division of Neurology 2, Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation and Research, US Food &amp; Drug Administration, Silver Spring, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1795-1542","authenticated-orcid":false,"given":"Laura E","family":"Baldassari","sequence":"additional","affiliation":[{"name":"Division of Neurology 2, Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation and Research, US Food &amp; Drug Administration, Silver Spring, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniela A","family":"Pimentel Maldonado","sequence":"additional","affiliation":[{"name":"Division of Neurology 2, Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation and Research, US Food &amp; Drug Administration, Silver Spring, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alice","family":"Hughes","sequence":"additional","affiliation":[{"name":"Division of Neurology 2, Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation and Research, US Food &amp; Drug Administration, Silver Spring, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2791-9001","authenticated-orcid":false,"given":"Vicky","family":"Chan","sequence":"additional","affiliation":[{"name":"Division of Pharmacovigilance I, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food &amp; Drug Administration, Silver Spring, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2025,10,26]]},"reference":[{"key":"e_1_3_2_2_2","volume-title":"Copaxone (glatiramer acetate) prescribing information","author":"Teva Neuroscience Inc","year":"2023","unstructured":"Teva Neuroscience Inc. 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