Updated on 2 September 2013
FDA investigates multifocal leukoencephalopathy (PML) in patient on Novartis multiple sclerosis drug Gilenya
Singapore: The US FDA raised an alert in Europe stating that multiple sclerosis patients who have been consuming Novartis drug Gilenya could develop a rare and serious brain infection.
The FDA reported one case of the diseases called progressive multifocal leukoencephalopathy (PML), following the administration of Gilenya to a patient who had not previously received Tysabri (natalizumab), an MS drug associated with a higher risk of PML.
FDA has notified that patients should not stop taking Gilenya without first discussing any questions or concerns with their healthcare professionals. The agency is investigating with Gilenya's manufacturer, Novartis, to obtain and review all available information about this occurrence.
PML is a rare and serious brain infection caused by the John Cunningham (JC) virus that damages the fatty covering of the brain called myelin. The fatty layer is essential for the proper functioning of nerves in the white matter of the brain. PML usually causes death or severe disability. The JC virus is a common virus that is harmless in most people but can cause PML in people who have weakened immune systems.
Gilenya is used to treat relapsing forms of MS, a nervous system disease that affects the brain and the spinal cord.