Safety Alerts & Recalls

What does this mean?

If you take Gilenya, you should continue to take it as prescribed – the benefits of Gilenya in treating MS will continue to outweigh the rare risk of PML for most patients.

The FDA will continue to investigate the PML case in cooperation with Novartis, Gilenya’s manufacturer, to obtain and review all available information about this case. The FDA will communicate their final conclusions and recommendations after their evaluation is complete.

In the meantime, be aware of the signs and symptoms of PML if you or a family member takes Gilenya. Symptoms of PML may include slowed mental function, disorientation, and behavioral changes. Other signs include a loss of coordination, changes in the ability to walk, or loss of voluntary muscle movement control. Muscle weakness may occur on one side of the body and disturbances of vision are also possible. In rare cases, seizures, communication difficulties, and/or headache can occur. These signs and symptoms can progress over the course of a few weeks and, once diagnosed, may result in death in weeks to months. Early detection of the condition and seeking medical attention as soon as symptoms appear is very important.

Please discuss any concerns that you may have about this safety alert with your doctor or other healthcare provider. If you notice any symptoms that concern you, please seek medical attention as soon as possible.

Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:

--- Telephone: 1-800-332-1088

--- Fax: 1-800-332-0178

--- Mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

--- Website:

FDA Investigating Report of Progressive Multifocal Leukoencephalopathy (PML) in Patient Taking Gilenya (Fingolimod)

The U.S. Food and Drug Administration (FDA) reports that a patient in Europe has developed the rare and serious brain infection called progressive multifocal leukoencephalopathy (PML) while taking Gilenya (fingolimod). Gilenya, which contains the active ingredient fingolimod, is used to treat relapsing forms of multiple sclerosis (MS). MS is a nervous system disease that affects the brain and spinal cord.

This is the first case of 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. The patient who developed PML while taking Gilenya received nearly eight months of treatment before being diagnosed with PML. The patient had previously received other MS treatments (including interferon beta-1a and azathioprine) for one month before receiving Gilenya treatment. The prior treatments were stopped when Gilenya was started. The patient also received multiple courses of intravenous corticosteroids for several months before and during Gilenya treatment.

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 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.

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Source: FDA
Publication Date: 2013-08-29
Last Updated: 2013-08-29

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