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FDA Warns of Gilenya Patients who Developed Brain Infection

Aug 5, 2015

The U.S. Food and Drug Administration (FDA) is updating the label on Gilenya, a drug used to treat multiple sclerosis, to include patients who developed a type of brain infection. According to a Drug Safety Communication posted on the agency's website on August 4, a case of definite progressive multifocal leukoencephalopathy (PML) and a probable case of PML have been linked to patients taking Gilenya. These are the first reported PML cases linked to Gilenya users who had not been previously treated with an immunosuppressant drug for MS or other medication condition.

Gilenya is used to treat patients with relapsing forms of MS, where symptoms worsen for periods of time. The FDA notice states that "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."

The FDA reported on a Gilenya patient who developed PML in August 2013. Because the patient had been taking immunosuppressant drugs, Gilenya could not be definitively linked to PML.

The FDA advises Gilenya patients to seek medical attention immediately if they experience symptoms such as new or worsening weakness; increased trouble using their arms or legs; or changes in thinking, eyesight, strength, or balance.

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