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Gilenya Lawsuits: PML Brain Infection

Gary P. Falkowitz
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  • Gilenya Lawsuits: Progressive Multifocal Leukoencephalopathy (PML) 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.

    Gilenya Lawsuits: PML Brain Infection Gilenya Lawsuits: PML Brain Infection

    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.

    Parker | Waichman Logo Legal Help for Gilenya Victims

    If you or someone you know developed PML after taking Gilenya, you may have valuable legal rights. Our firm offers free, no-obligation legal consultations. For more information, fill out our online form or call one of our experienced personal injury attorneys today at1-800-YOURLAWYER (1-800-968-7529).


    Gilenya Lawsuits: PML Brain InfectionRSS Feed

    Canadian Health Regulatory Agency Issues New Safety Information for Multiple Sclerosis Drug Gilenya

    Oct 1, 2015
    Health Canada, the Canadian health regulatory agency, has updated the drug label for the multiple sclerosis drug Gilenya (fingolimod) to include new safety information on the risk of skin cancer, as well as a rare brain infection known as progressive multifocal leukoencephalopathy (PML), which can be fatal. Gilenya is a prescription drug used in the treatment of relapsing-remitting multiple sclerosis (MS) to reduce the frequency of attacks (relapses) and delay the progression of physical...

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