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News From the Food and Drug Administration
September 15, 2015

Brain Disease Linked With MS Drug

Author Affiliations

Copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2015;314(11):1108. doi:10.1001/jama.2015.11140

Fingolimod, a multiple sclerosis (MS) drug marketed as Gilenya, has been linked with progressive multifocal leukoencephalopathy (PML) in 2 patients, the FDA has warned ( The agency noted that information about the cases, provided by Gilenya’s manufacturer, Novartis, is being added to the drug label.

Progressive multifocal leukoencephalopathy is a rare, serious brain infection caused by the John Cunningham (JC) virus. Symptoms of PML include new or worsening weakness; clumsiness; and changes in thinking, eyesight, strength, or balance. Infection with the JC virus is harmless in most people but can cause PML in those with a weakened immune system, including patients who take immunosuppressant drugs. Magnetic resonance imaging may detect brain lesions before symptoms develop. Within the first few months after diagnosis, however, PML has a mortality rate ranging from 30% to 50% (

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