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Adverse Events Associated with Fosfomycin Use: Review of the Literature and Analyses of the FDA Adverse Event Reporting System Database

机译：与磷霉素相关的不良事件：FDA不良事件报告系统数据库的文献资料和分析

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Introduction The growing problem of antibacterial resistance resulted in an increased interest in fosfomycin, especially its parenteral formulation. We reviewed fosfomycin safety profile using the Food and Drug Administration Adverse Event (AE) Reporting System (FAERS) and published literature. Methods We conducted a FAERS search and disproportionality analysis of all fosfomycin-associated AEs. We also conducted a FAERS search for AEs implicating fosfomycin as the primary suspect and a search of reports of fosfomycin-associated bone marrow toxicity. We then review the literature for publications reporting AEs associated with fosfomycin by conducting PubMed searches. Results The disproportionality analysis of all FAERS reports of fosfomycin-associated AEs produced a higher than expected frequency of agranulocytosis, liver injury, severe skin reactions, and pseudomembranous colitis. Subsequent search for AEs where fosfomycin was the primary suspect and the literature review did not suggest a higher association of fosfomycin with these AEs. The search of bone marrow toxicity reports did not demonstrate an association between aplastic anemia and fosfomycin. The literature review selected 23 trials of parenteral administration of fosfomycin in 1242 patients including 8 comparative and 15 non-comparative trials. For oral fosfomycin, only prospective comparative trials ( n =?28) in 2743 patients were included. The most frequent AEs associated with parenteral fosfomycin included rash, peripheral phlebitis, hypokalemia, and gastrointestinal disorders. Serious AEs such as aplastic anemia, anaphylaxis, and liver toxicities were reported infrequently. Gastrointestinal disorders were the most common AEs associated with oral fosfomycin. Conclusion The identified AEs were consistent with the safety profile of fosfomycin. No new safety signals related to either parenteral or oral fosfomycin were identified.
机译：引言日益增长的抗药性问题导致人们对磷霉素，特别是其肠胃外制剂的兴趣增加。我们使用食品和药物管理局不良事件（AE）报告系统（FAERS）审查了磷霉素的安全性，并发布了文献。方法我们对与磷霉素相关的所有AE进行了FAERS搜索和不成比例分析。我们还进行了FAERS搜索，发现牵涉磷霉素的主要不良事件是AE，并搜索了磷霉素相关的骨髓毒性报告。然后，我们通过进行PubMed搜索，回顾了报道与磷霉素相关的AE的出版物的文献。结果所有与磷霉素相关的AE的FAERS报告的不成比例分析均导致了高于预期的粒细胞缺乏症，肝损伤，严重的皮肤反应和假膜性结肠炎。随后寻找以磷霉素为主要嫌疑人的不良事件，并且文献综述未表明磷霉素与这些不良事件有更高的相关性。骨髓毒性报告的搜索未显示再生障碍性贫血和磷霉素之间存在关联。文献综述选择了23项非磷霉素非肠道给药试验，共治疗了1242例患者，其中包括8项比较试验和15项非比较试验。对于口服磷霉素，仅包括2743名患者的前瞻性比较试验（n = 28）。与肠胃外磷霉素相关的最常见的不良事件包括皮疹，周围静脉炎，低血钾和胃肠道疾病。很少报道严重的不良事件，如再生障碍性贫血，过敏反应和肝毒性。胃肠道疾病是与口服磷霉素相关的最常见的不良事件。结论鉴定出的不良事件与磷霉素的安全性相符。没有发现与肠胃外或口服磷霉素相关的新安全性信号。

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