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Gilenya Labels to be Updated to Include Warnings for PML Cases

On August 4, 2014, the Food and Drug Administration (FDA) announced labels for Novartis’ Gilenya will be revised to include information about a case of progressive multifocal leukoencephalopathy (PML) and another probable case of PML. Gilenya is a treatment used for patients with relapsing forms of multiple sclerosis.

These are the first PML cases reported in patients who have not taken another immunosuppressant for MS or any other condition. In August 2013, the FDA did report a case where a patient developed PML after taking the treatment. However, the patient was also treated with other immunosuppressants in addition to Gilenya.

PML is a rare, opportunistic infection of the brain which causes severe damage to the white matter. It can occur in people who have weakened immune systems and have been infected with the John Cunningham (JC) virus. The JC virus is a common virus and harmless in most people except those with weakened immune systems.

Patients taking the treatment should contact their doctor immediately if they experience symptoms including new or worsening weakness, increased issues using arms or legs, or changes in cognitive function, vision, strength or balance. Patients should not stop taking the treatment until they discuss with their doctor. The FDA also urges healthcare professionals and patients to report any side effects from the treatment to the FDA MedWatch.

Gilenya was approved for use in the United States in 2010 and in Europe in 2011. Label revisions also occurred in Biogen Idec’s Tecfidera in November 2014 and Biogen Idec’s Tysabri in 2009.1,2

For more information regarding updates to Gilenya’s label, visit the FDA’s announcement.

  1. FDA Drug Safety Communication: FDA warns about cases of rare brain infection with MS drug Gilenya (fingolimod) in two patients with no prior exposure to immunosuppressant drugs. The Food and Drug Administration. Published August 4, 2015. Accessed August 5, 2015.
  2. Barber J. Label of Novartis' Gilenya to be updated after FDA warns of PML cases. First Word Pharma. Published August 4, 2015. Accessed August 5, 2015.


  • Applehead
    4 years ago

    Thank you for this very relevant article. I recall when this drug came out………..I was suspicious of the data and was aware of PML involvement. I warned others in my MS group and was told to not bring up the negatives unless I was at the curb!!! I felt the drug company was putting the HORSE BEFORE THE CARRIAGE. I believe we as MS SUFFERERS still do not have all the real data and truths about these problem drugs.. It will eventually be EXPOSED, PML is SERIOUS. This label is a little late and short. I understand the desperation and futility we as Ms sufferers have. I myself have PPMS. Currently being kicked to the curb myself in a relationship and the stress is impacting me significantly. REGARDS…….

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