FDA近日发表声明称，既往未服用那他珠单抗（Tysabri）治疗的
FDA网站上声明中称，这是第一例既往未接受那他珠单抗治疗的MS患者，在服用芬戈莫德治疗后出现进行性多灶性白质脑病。该例欧洲患者被诊断为PML时，已经服用芬戈莫德近8个月。尽管这样，主管部门并未称，这是由于芬戈莫德药物所致。
主管部门称，“我们正与芬戈莫德药物的制造商（诺华公司）一起，竭力收集有关该事件的所有信息，待评估结束后，我们将传达最终的决定与建议。”
对此，诺华公司发明了一份声明称，在现阶段，公司认为服用芬戈莫德与PML的发生无关，该声明已在七月底公开报道。公司声明称，“经过总结回顾所有可用信息后，我们认为PML事件中的一些现象是不太可能由于服用芬戈莫德引起的。”
诺华公司、FDA均注意到，该例患者并非仅单服芬戈莫德。FDA说，“在开始芬戈莫德治疗前，患者已用干扰素β-1a及
诺华公司称，在开始芬戈莫德治疗前，患者已行脑部核磁共振（MRI）扫描，而且患者可能已经出现了PML，因为病灶与典型的MS影响表现不符。
PML是由于潜伏的JC病毒感染被激活所致，一般发生于急性或慢性免疫力缺陷患者中。最新研究显示其死亡率大约20%。首次报道是在接受癌症化疗以及HIV晚期的患者中。2004年，那他珠单抗首次被批准后，出现了一系列的PML病患，以致那他珠单抗暂时撤出了市场。FDA称，该例患者不仅脑脊液中存在JCB病毒DNA而且出现了临床症状，因此芬戈莫德被禁止使用。声明中指出该患者仍然活着。
FDA建议临床医师在不良反应事件登记系统中报告芬戈莫德的副作用。同时也告知患者急需服用目前的药物除非由医师告知停用。
编译自：FDA Warns of PML Case With Gilenya.medpagetoday.Aug 29, 2013
FDA原文：
The U.S. Food and Drug Administration (FDA) is alerting the public that a patient in Europe diagnosed with possible multiple sclerosis (MS) has developed a rare and serious brain infection after taking the drug Gilenya (fingolimod). This is the first case of this disease, called progressive multifocal leukoencephalopathy or PML, reported following the administration of Gilenya to a patient who had not previously received Tysabri (natalizumab), an MS drug associated with a higher risk of PML.
Patients should not stop taking Gilenya without first discussing any questions or concerns with their health care professionals. We are providing this alert while we continue to investigate the PML case, and we are working with Gilenya’s manufacturer, Novartis, to obtain and review all available information about this occurrence. We will communicate our final conclusions and recommendations after our evaluation is complete.
PML is a rare and serious brain infection caused by the John Cunningham (JC) virus that damages the fatty covering of the brain called myelin. Myelin is essential for the proper functioning of nerves in the white matter of the brain. PML usually causes death or severe disability. The JC virus is a common virus that is harmless in most people but can cause PML in people who have weakened immune systems. Some medications, including Gilenya, can weaken the immune system.
Gilenya is used to treat relapsing forms of MS, a nervous system disease that affects the brain and spinal cord. MS is thought to affect more than 2 million people worldwide. The drug was approved for use in the United States in September 2010. Novartis reports that approximately 71,000 patients worldwide have been treated with Gilenya.
The patient who developed PML received nearly eight months of Gilenya treatment before being diagnosed with PML. The patient had been treated with interferon beta-1a and azathioprine for one month before initiating Gilenya treatment; those medications were stopped when Gilenya was started. The patient also received multiple courses of intravenous corticosteroids for several months before and during Gilenya treatment. The diagnosis was made based on clinical symptoms and the detection of JC viral DNA in the cerebrospinal fluid. Gilenya treatment was stopped.
We urge health care professionals and patients to report side effects involving Gilenya to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.
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