FDA Drug Safety Communication: FDA investigating rare brain infection in patient taking Gilenya (fingolimod)
The FDA has issued new information about this safety issue, see the FDA Drug Safety Communication issued 08-04-2015.
[8/29/2013] The U.S. Food and Drug Administration (FDA) is alerting the public that a patient in Europe diagnosed with possible multiple sclerosis (MS) has developed a rare and serious brain infection after taking the drug Gilenya (fingolimod). This is the first case of this disease, called progressive multifocal leukoencephalopathy or PML, reported 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.
Patients should not stop taking Gilenya without first discussing any questions or concerns with their health care professionals. We are providing this alert while we continue to investigate the PML case, and we are working with Gilenya’s manufacturer, Novartis, to obtain and review all available information about this occurrence. We will communicate our final conclusions and recommendations after our evaluation is complete.
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. Myelin 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. Some medications, including Gilenya, can weaken the immune system.
Gilenya is used to treat relapsing forms of MS, a nervous system disease that affects the brain and spinal cord. MS is thought to affect more than 2 million people worldwide. The drug was approved for use in the United States in September 2010. Novartis reports that approximately 71,000 patients worldwide have been treated with Gilenya.
The patient who developed PML received nearly eight months of Gilenya treatment before being diagnosed with PML. The patient had been treated with interferon beta-1a and azathioprine for one month before initiating Gilenya treatment; those medications were stopped when Gilenya was started. The patient also received multiple courses of intravenous corticosteroids for several months before and during Gilenya treatment. The diagnosis was made based on clinical symptoms and the detection of JC viral DNA in the cerebrospinal fluid. Gilenya treatment was stopped.
We urge health care professionals and patients to report side effects involving Gilenya to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.
For more information about Gilenya, read the patient Medication Guide (PDF - 216KB) or the Risk Evaluation and Mitigation Strategy (REMS) (PDF - 473KB).
Gilenya Medication Guide(PDF - 134KB) Gilenya (fingolimod) Capsules NDA 22-527/s-010(PDF - 1.2MB) Fingolimod (marketed as Gilenya) Information FDA Drug Safety Podcast: FDA investigating rare brain infection in patient taking Gilenya (fingolimod) FDA Drug Safety Communication: FDA warns about cases of rare brain infection with MS drug Gilenya (fingolimod) in two patients with no prior exposure to immunosuppressant drugs