You are here

FDA Warning: Rare Cases of Brain Infection Reported With Fingolimod (Gilenya)

Agency to revise drug label

The FDA is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in multiple sclerosis (MS) patients treated with fingolimod (Gilenya, Novartis).

These are the first cases of PML reported in patients receiving fingolimod 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.

Fingolimod is an immunomodulator shown to benefit patients with relapsing forms of MS. 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, the FDA reported that a patient developed PML after receiving fingolimod. PML could not be conclusively linked to fingolimod in this case because prior to fingolimod treatment the patient had been treated with an immunosuppressant drug that can cause PML. Moreover, during fingolimod therapy the patient had received multiple courses of intravenous corticosteroids, which can weaken the immune system.

Source: FDA; August 3, 2015.

Recent Headlines

Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs
Acasti reports disappointing results for a second Omega-3-based drug
So far in January, the increases average 5%
Fast-acting insulin aspart may simplify mealtime dosing
Simple change in dosage and route may improve a century-old vaccine
Neurodevelopmental deficits detected in Colombian toddlers