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FDA Warning: Rare Cases of Brain Infection Reported With Fingolimod (Gilenya)

Agency to revise drug label

The FDA is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in multiple sclerosis (MS) patients treated with fingolimod (Gilenya, Novartis).

These are the first cases of PML reported in patients receiving fingolimod 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.

Fingolimod is an immunomodulator shown to benefit patients with relapsing forms of MS. Immunomodulators alter the immune system to reduce inflammation. PML is a rare and serious brain infection caused by the John Cunningham (JC) virus. The JC virus is a common virus that is harmless in most people but can cause PML in some patients who have weakened immune systems, including those taking immunosuppressant drugs. 

In an August 2013 drug safety communication, the FDA reported that a patient developed PML after receiving fingolimod. PML could not be conclusively linked to fingolimod in this case because prior to fingolimod treatment the patient had been treated with an immunosuppressant drug that can cause PML. Moreover, during fingolimod therapy the patient had received multiple courses of intravenous corticosteroids, which can weaken the immune system.

Source: FDA; August 3, 2015.

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