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FDA Reports Recent Case of Brain Infection With Gilenya
PML is caused by the John Cunningham (JC) virus, which damages myelin, the fatty covering of the brain. PML usually results in death or severe disability and mostly affects those with weakened immune systems.
Patients should not discontinue fingolimod therapy without first consulting their health care professional. Novartis stated that the firm does not believe fingolimod was responsible for PML in this case. The patient was taking other drugs besides fingolimod, Novartis and the FDA explained.