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.

中文翻译：

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扩大与富马酸二甲酯相关的机会性感染谱

背景 目前，富马酸二甲酯 (DMF) 的处方信息仅描述了进行性多灶性白质脑病 (PML)。目的 描述与 DMF 相关的机会性感染 (OI)，而不是 PML。方法 检索 FDA 不良事件报告系统 (FAERS) 和医学文献。结果 我们检索到 34 例与 DMF 有因果关系的严重 OI，包括 11 例中枢神经系统 (CNS) 感染和 23 例中枢神经系统外感染。发生 6 次 OIs，循环绝对淋巴细胞计数正常。从 DMF 开始的中位潜伏期为 13 个月并且是可变的。结论 DMF 与需要侵入性诊断和/或治疗程序的 OI 的发展有关。