FDA Warns of First Cases of PML Associated with MS Drug Gilenya

Washington, DC: The US Food and Drug Administration (FDA) is warning that a case of definite progressive multifocal leukoencephalopathy (PML) ( and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS).

These are the first cases of PML reported in patients taking Gilenya 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.

Gilenya is an immunomodulator shown to benefit patients with relapsing forms of MS. This type of MS causes attacks or relapses, which are periods of time when symptoms get worse. 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, FDA reported that a patient developed PML after taking Gilenya. PML could not be conclusively linked to Gilenya in this case because prior to Gilenya treatment the patient had been treated with an immunosuppressant drug that can cause PML and during Gilenya treatment the patient had received multiple courses of intravenous corticosteroids, which can weaken the immune system.

The FDA notes in their statement that symptoms of PML include new or worsening weakness; increased trouble using their arms or legs; or changes in thinking, eyesight, strength, or balance.

Legal Help

If you or a loved one has suffered similar damages or injuries, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Last updated on Aug-4-15