Product News and Recalls

Gilenya a Possible Link to Rare Brain Infection

The U.S. Food and Drug Administration has issued an alert to the public indicating that a patient in Europe diagnosed with possible multiple sclerosis has developed a rare and serious brain infection after taking Gilenya.

Gilenya is used to treat relapsing forms of MS, a nervous system disease that affects the brain and spinal cord. This is the first case of progressive multifocal leukoencephalopathy (PML), which is a rare and serious brain infection caused by the John Cunningham (JC) virus that damages the fatty covering of the brain called myelin. PML is known to cause death or severe disability.

Gilenya’s manufacturer, Novartis, reports that roughly 71,000 patients are being treated with their drug. The FDA
urges patients to discuss concerns of Gilenya with health care professionals, and will continue to investigate this occurrence. They will be working with Novartis to review all available information about this instance.

You should consult with a doctor if you have any ongoing symptoms or health concerns and before making any changes in medication. You should also consult with a Lopez McHugh attorney if you have injuries connected with Gilenya.