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Gilenya (fingolimod) - Drug Safety Communication: Investigating Rare Brain Infection

AUDIENCE: Neurology, Pharmacy

ISSUE: 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 progressive multifocal leukoencephalopathy (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.

BACKGROUND: 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. PML usually causes death or severe disability. Gilenya is used to treat relapsing forms of MS, a nervous system disease that affects the brain and spinal cord. Novartis reports that approximately 71,000 patients worldwide have been treated with Gilenya.

RECOMMENDATION: Patients should not stop taking Gilenya without first discussing any questions or concerns with their health care professionals. FDA is providing this alert while continuing to investigate the PML case, and is working with Gilenya’s manufacturer, Novartis, to obtain and review all available information about this occurrence. FDA will communicate its final conclusions and recommendations after the evaluation is complete.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

‧ Complete and submit the report Online:
‧ Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the complete MedWatch Safety Alert, including a link to the Drug Safety Communication, at:

FDA告知大眾,歐洲一名診斷為多發性硬化症(multiple sclerosis, MS)病人在服用Gilenya (fingolimod)後發生罕見且嚴重之腦部感染。此為第一例給予Gilneya後發生進行性多灶性白質腦病(leukoencephalopathy, PML)之案例,此病人未曾用過Tysabri (natalizumab,另一治療多發性硬化症藥物,用藥病人有較高罹患PML之風險)。


PML為John Cunningham (JC)病毒引起,其可能會損害大腦之髓鞘,造成罕見且嚴重之腦部感染。罹患PML易造成死亡或重度殘疾。Gilenya為用於治療復發性之多發性硬化症,一種影響腦部及脊髓之神經系統疾病。目前全球約有71,000名病人使用Gilenya。