Gilenya May Cause Brain Infection. Our firm is investigating potential lawsuits on behalf of Gilenya users who developed progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection. The U.S. Food and Drug Administration (FDA) reported cases of PML among Gilenya users in 2013, and again in August 2015. The most recent cases were the first to be linked to ‘Gilenya’ users not using immunosuppressant drugs.
If your or someone you know developed PML after using ‘Gilenya’, contact Parker Waichman LLP today.
FDA Warns of Gilenya Patients who Developed Rare Brain Infection
Gilenya is a drug used to treat relapsing forms of multiple sclerosis (MS), in which symptoms worsen for periods of time. ‘Gilenya’ is an immunomodulator, which means that the drug changes the immune system, in order to reduce inflammation associated with MS.
The FDA reported that a ‘Gilenya’ patient developed PML in August 2013. The John Cunningham (JC) virus causes PML, which is a rare and serious brain infection. In most people, exposure to the JC virus is harmless. Individuals with weakened immune systems, however, may develop PML; this includes those taking immunosuppressant drugs. The August 2013 PML case was found in a patient treated with an immunosuppressant drug that may cause PML; therefore, the condition could not be conclusively linked to ‘Gilenya’.
In August 2015, the FDA reported on a case of definite PML and another probable case of PML in patients taking Gilenya for MS. The agency noted that these are the first cases of PML reported in ‘Gilenya’ patients not taking an immunosuppressant drugs. The drug label was updated as a result.