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First Reporting of Gilenya Consumption Causing Brain Infection, FDA Says

Filed August 30th, 2013 edlieber1

The U.S. Food and Drug Administration (FDA) is notifying the public that a patient in Europe diagnosed with possible multiple sclerosis (MS) has developed a serious brain infection after taking the drug Gilenya (fingolimod).

This is believed to be 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, an MS drug associated with a higher risk of PML. The agency is recommending that patients speak to their health care professionals before discontinuing use of Gilenya.

The FDA said it is continuing to investigate the PML case, and is working with Gilenya’s manufacturer, Novartis, to obtain and review all available information about this occurrence. The agency said it will communicate its final conclusions and recommendations after the 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, according to the FDA’s release. Myelin is essential for the proper functioning of nerves in the white matter of the brain. PML usually causes death or severe disability.

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.

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