The Food and Drug Administration has warned that patients with multiple sclerosis who are treated with the drug Gilenya (fingolimod) may be at risk of developing a serious form of brain infection known as progressive multifocal leukoencephalopathy (PML). Gilenya is an immunomodulator that is prescribed to patients with relapsing forms of MS, who may experience occasional periods in which their symptoms become worse.
PML brain infections are caused by exposure to the John Cunningham (JC) virus. Although the JC virus is common and usually harmless in most patients, it can lead to PML in patients with weak or compromised immune systems, including those being treated with immunosuppressants such as Gilenya.
The FDA’s concerns about the link between Gilenya and PML first arose in 2013, when a patient with MS who was being treated with the drug was diagnosed with the brain infection. However, because the patient had also been treated with an immunosuppressant drug that can cause PML—as well as corticosteroids, which can weaken the immune system—doctors could not be certain of the link between Gilenya and brain infections.
The FDA warning about Gilenya was issued after the agency received a report about a second patient who was diagnosed with PML after taking the MS drug. Unlike the first patient, this second individual had not been treated with immunosuppressant drugs prior to being diagnosed with PML.
The FDA has advised patients being treated with Gilenya to talk with their doctor if they experience symptoms which may be a sign of PML. Symptoms of the brain infection may include changes in thinking, eyesight, strength, or balance; weakness that is new or worsens; and trouble moving the arms or legs.
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