Infectious Diseases, Nanotherapeutics, Inc, Alachua, Florida 32615, USA.
Clin Infect Dis. 2011 Jun;52 Suppl 7:S527-37. doi: 10.1093/cid/cir168.
Fusidic acid has been in clinical use outside the United States (US) since 1962 for skin infections, including methicillin-resistant Staphylococcus aureus (MRSA). Non-US labeling reflects safety concerns related to gastrointestinal, allergic, hematologic, and neurologic adverse events. We sought to survey available safety data on fusidic acid through the review of published global literature between 1962 and 2007 that contained data on oral fusidic acid safety and a centralized database (VigiBase) of spontaneous safety reports. Overall, the data were concordant with current product labeling, and no serious adverse events, such as death, hospitalization, or hepatotoxicity, were convincingly linked to fusidic acid monotherapy in skin infection patients. Other indications for fusidic acid use were also common, including osteomyelitis with similar reporting of labeled safety characteristics. Study quality was highly varied with limited structure to safety data collection methodology. Significant concerns for recall bias are present, yet these data remain informative in providing signals that require attention in the design and conduct of adequate and well-controlled clinical studies of fusidic acid for potential registration in the United States.
夫西地酸于 1962 年在美国以外的地区被应用于治疗皮肤感染，包括耐甲氧西林金黄色葡萄球菌（MRSA）感染。非美国地区的标签反映了与胃肠道、过敏、血液学和神经系统不良事件相关的安全问题。我们通过对 1962 年至 2007 年期间发表的全球文献进行回顾，检索到了有关口服夫西地酸安全性的数据，以及一个集中的不良反应自发报告数据库（VigiBase），以获取夫西地酸的安全性数据。总的来说，这些数据与目前的产品标签一致，在皮肤感染患者中单用夫西地酸治疗并没有令人信服地与严重不良事件（如死亡、住院或肝毒性）相关联。夫西地酸的其他适应证也很常见，包括骨髓炎，且具有类似的标签安全性特征的报告。研究质量差异很大，安全性数据收集方法的结构有限。存在明显的回忆偏倚问题，但这些数据仍然为提供信号提供了信息，需要在设计和进行充分和良好对照的临床试验中引起关注，以评估夫西地酸在美国的注册潜力。
