| アブストラクト | BACKGROUND: Only progressive multifocal leukoencephalopathy (PML) is currently described in the dimethyl fumarate (DMF) prescribing information. OBJECTIVES: To describe opportunistic infections (OIs), other than PML, reported in association with DMF. METHODS: The FDA Adverse Event Reporting System (FAERS) and medical literature were searched. RESULTS: 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 months and was variable. CONCLUSION: 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. |
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| ジャーナル名 | Multiple sclerosis (Houndmills, Basingstoke, England) |
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| 投稿日 | 2020/12/11 |
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| 投稿者 | Kim, Tiffany; Croteau, David; Brinker, Allen; Jones, David E; Lee, Paul R; Kortepeter, Cindy M |
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| 組織名 | Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center;for Drug Evaluation and Research, U.S. Food & Drug Administration, Silver Spring,;MD, USA.;Division of Neurology, Office of Neurology, Office of New Drugs, Center for Drug;Evaluation and Research, U.S. Food & Drug Administration, Silver Spring, MD, USA. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/33300850/ |
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