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【medical-news】FDA：TNF抑制剂可能导致真菌感染
Agency invokes new authorities under FDAAA to alert patients and prescribers to risk 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections
Agency invokes new authorities under FDAAA to alert patients and prescribers to risk
肿瘤坏死因子阻滞剂药物的生产商必须强调其对真菌感染的风险
代理处基于修正案所获得的新权力来警告患者和开药者所面对的风险
The U.S. Food and Drug Administration today announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died.
美国食品药品监督管理局今天宣布，四个药物Humira,CimZia,Enbrel和Remicade必须加强目前在在药物处方信息和用药指南的告诫事项和预防措施上的警告，说明会造成真菌感染的风险。
The four drugs, known as tumor necrosis factor alpha blockers (TNF-alpha blockers), which suppress the immune system, are approved to treat a variety of conditions which may include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn's disease.
四个药物，作为肿瘤坏死因子阻滞剂，能抑制免疫系统，已被批准用来治疗各种症状如风湿性关节炎，青少年先天性关节炎，牛皮藓关节炎，银屑病，脊柱炎和克罗恩氏病。
FDA today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 to require manufacturers of TNF inhibitors to make safety-related changes to prescribing information, or labeling.
FDA今天根据2007年的食品和药品管理修正案行使了新的权利，要求TNF阻滞剂的生产商对处方和标签信息进行进行安全性相关的改写。
“Under the FDA's new authorities, we can require safety label changes and a risk evaluation and mitigation strategy, known as REMS, when the agency becomes aware of new safety information,” said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia and Rheumatology Products, Center for Drug Evaluation and Research. “Requiring the risks to be highlighted will help health care professionals be more vigilant in watching for these adverse events, and is necessary to ensure that the benefits of these drugs outweigh their risks.”
药审中心的麻醉、止痛和风湿病部门主任鲍勃.帕波尔特医学博士说，在FDA新的权力监管下，当注意到新的安全信息，我们能够像远程设备管理系统一样，要求安全的标签更改和风险评估。强调风险的命令将有助于健康保健专家警惕这些不良反应，并且对确保这些药物利大于弊也是有必要的。
Since the initial approval of the four TNF blockers, the prescribing information for these drugs has included information about the risk of serious infections, including fungal infections. However, based on reports reviewed by FDA, health care professionals are not consistently recognizing cases of histoplasmosis and other invasive fungal infections, leading to delays in treatment.
自从这四个药物被批注之日起，他们的处方信息就包括了严重感染的风险，如真菌感染。但是，根据FDA的报告，健康保健专家并不是一直能意识到网状内皮细胞真菌病和其他侵入式的感染，这会导致治疗的延误。
Patients taking TNF blockers should be aware that they are more susceptible to serious fungal infections. Those who develop a persistent fever, cough, shortness of breath, and fatigue should promptly seek medical attention. To assist in the diagnosis, those being treated with TNF blockers should tell their health care professionals where they live and what areas they have recently visited. Patients who develop a fungal infection may be advised to stop the TNF blocker until they recover.
使用TNF阻滞剂的患者应该注意到他们更易受到严重的真菌感染。那些发展为持续高热，咳嗽，气喘和疲劳的患者应当迅速的寻求医学建议。为了有助于诊断，使用TNF阻滞剂的患者应该告知他们的健康保健专家自己住在什么地方和最近去过那些地点。受到真菌感染的患者可能会被建议在真菌疾病康复前中止使用TNF阻滞剂。
FDA has reviewed 240 reports of histoplasmosis, an infection caused by the fungus Histoplasma capsulatum, in patients being treated with Enbrel, Humira, or Remicade. The majority of the reports involved people in the Ohio River and Mississippi River valleys (the fungus is commonly found in those areas). In at least 21 of the reports, histoplasmosis was initially not recognized by health care professionals, and antifungal treatment was delayed. Twelve of those patients died.
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作者:admin@医学,生命科学 2010-12-24 15:20
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