FDA Warns About Cases of Rare Brain Infection

FDA is warning that a definite case of progressive multifocal leukoencephalopathy (PML) and a probable case of PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS). These are the first cases of PML reported in patients taking Gilenya who had not been previously treated with an immunosuppressant drug for MS or any other medical condition. As a result, information about these recent cases is being added to the drug label. [8/5/15]

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