{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,18]],"date-time":"2026-06-18T10:41:43Z","timestamp":1781779303274,"version":"3.54.5"},"reference-count":12,"publisher":"SAGE Publications","issue":"8","license":[{"start":{"date-parts":[[2020,12,10]],"date-time":"2020-12-10T00:00:00Z","timestamp":1607558400000},"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":[[2021,7]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Only progressive multifocal leukoencephalopathy (PML) is currently described in the dimethyl fumarate (DMF) prescribing information.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>To describe opportunistic infections (OIs), other than PML, reported in association with DMF.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>The FDA Adverse Event Reporting System (FAERS) and medical literature were searched.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>We retrieved 34 cases of serious OIs with a causal association with DMF, including 11 central nervous system (CNS) infections and 23 extra-CNS infections. Six OIs occurred with normal circulating absolute lymphocyte counts. The median latency from DMF initiation was 13\u2009months and was variable.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>DMF is associated with the development of OIs that require invasive diagnostic and\/or therapeutic procedures. Patients should be monitored for OIs when treated with DMF regardless of circulating absolute lymphocyte counts.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/1352458520977132","type":"journal-article","created":{"date-parts":[[2020,12,10]],"date-time":"2020-12-10T14:13:14Z","timestamp":1607609594000},"page":"1301-1305","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":10,"title":["Expanding spectrum of opportunistic infections associated with dimethyl fumarate"],"prefix":"10.1177","volume":"27","author":[{"given":"Tiffany","family":"Kim","sequence":"first","affiliation":[{"name":"Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food &amp; Drug Administration, Silver Spring, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Croteau","sequence":"additional","affiliation":[{"name":"Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food &amp; Drug Administration, Silver Spring, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allen","family":"Brinker","sequence":"additional","affiliation":[{"name":"Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food &amp; Drug Administration, Silver Spring, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David E","family":"Jones","sequence":"additional","affiliation":[{"name":"Division of Neurology, Office of Neurology, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food &amp; Drug Administration, Silver Spring, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul R","family":"Lee","sequence":"additional","affiliation":[{"name":"Division of Neurology, Office of Neurology, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food &amp; Drug Administration, Silver Spring, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cindy M","family":"Kortepeter","sequence":"additional","affiliation":[{"name":"Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food &amp; Drug Administration, Silver Spring, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2020,12,10]]},"reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1206328"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1114287"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1177\/2055217315596994."},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1002685"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0196-0644(98)70008-3"},{"key":"e_1_3_2_7_2","volume-title":"Tecfidera","author":"Biogen Inc","year":"2020","unstructured":"Biogen Inc. Tecfidera (Package Insert). Cambridge, MA: Biogen Inc, 2020."},{"key":"e_1_3_2_8_2","unstructured":"U.S. Food & Drug Administration. Questions and Answers on FDA\u2019s Adverse Event Reporting System (FAERS) 2018 https:\/\/www.fda.gov\/Drugs\/GuidanceComplianceRegulatoryInformation\/Surveillance\/AdverseDrugEffects\/ (accessed 1 July 2020)."},{"key":"e_1_3_2_9_2","unstructured":"Postmarketing reporting of adverse drug experiences\u2014Electronic Code of Federal Regulations title 21: Food and drugs part 314 https:\/\/www.ecfr.gov\/cgi-bin\/text-idx?SID=eb822077c27330d63a938f32733fd508&mc=true&node=se21.5.314_180&rgn=div8 (accessed 1 July 2020)."},{"key":"e_1_3_2_10_2","volume-title":"Guidance for industry: Good pharmacovigilance practices and pharmacoepidemiologic assessment","author":"U.S. Food & Drug Administration","year":"2005","unstructured":"U.S. Food & Drug Administration. Guidance for industry: Good pharmacovigilance practices and pharmacoepidemiologic assessment. Silver Spring, MD: U.S. Food & Drug Administration, 2005."},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1212\/NXI.0000000000000076"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1212\/NXI.0000000000000183"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0149-2918(98)80007-6"}],"container-title":["Multiple Sclerosis Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1352458520977132","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/1352458520977132","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1352458520977132","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,2]],"date-time":"2026-05-02T04:05:31Z","timestamp":1777694731000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/1352458520977132"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,12,10]]},"references-count":12,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2021,7]]}},"alternative-id":["10.1177\/1352458520977132"],"URL":"https:\/\/doi.org\/10.1177\/1352458520977132","relation":{},"ISSN":["1352-4585","1477-0970"],"issn-type":[{"value":"1352-4585","type":"print"},{"value":"1477-0970","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,12,10]]}}}