Gilenya Safety Alert

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Gilenya and PML

The U.S. Food and Drug Administration (FDA) has issued a drug safety communication regarding Gilenya, a drug the agency believes might be associated with a rare brain infection.

The FDA reported that a patient in Europe who was diagnosed with possible multiple sclerosis (MS) has since developed a rare brain infection. The serious infection, named progressive multifocal leukoencephalopathy (PML) was found in a patient who had previously taken the drug Gilenya.

Gilenya and Multiple Sclerosis

Gilenya is a prescription drug used to treat relapsing forms of MS, a nervous system disease that affects the brain and spinal cord. Worldwide, it is estimated that more than 2 million people are affected by the disease. Of those 2 million people, approximately 71,000 have been treated with Gilenya.

The FDA describes progressive multifocal leukoencephalopathy (PML) as a “rare and serious brain infection caused by the John Cunningham virus that damages the fatty covering of the brain called myelin. 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. Novartis reports that approximately 71,000 patients worldwide have been treated with Gilenya.”

The FDA recommends that healthcare professionals and patients report side effects involving Gilenya to the FDA MedWatch program.

For more information, view the full FDA Gilenya Safety Alert.

If you or someone you know has been injured by Gilenya, call Longo Legal, PLLC to find out if you have a potential claim. The first step is to get some preliminary information over the phone. The initial phone call and consultation cost you nothing. You will not pay Longo Legal, PLLC anything towards your Gilenya lawsuit unless a recovery is made on your behalf. Call Longo Legal at (855) 566-4648 to see if you qualify.

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