FDA Issues Warning about Multiple Sclerosis Drug

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The US Food and Drug Administration has issued a safety warning that a drug approved for use in 2010 to treat multiple sclerosis may be linked to a rare and serious brain infection. Approximately 71,000 patients worldwide have been treated with Gilenya (fingolimod) by Novartis, and only one patient case has been reported. However, for the utmost in safety, the FDA is letting the public know about the possible connection.

Gilenya is used to treat relapsing forms of MS, a nervous system disease that affects the brain and spinal cord. It is thought to affect more than 2 million people worldwide. Gilenya is thought to work by reducing the immune system’s attack on the central nervous system by retaining certain white blood cells in the lymph nodes, preventing them from reaching the CNS, resulting in less inflammatory damage.

The FDA has received a report that a patient in Europe taking Gilenya for only 8 months has developed progressive multifocal leukoencephalopathy or PML. Caused by the John Cunningham (JC) virus which damages the fatty covering of the brain called myelin, PML usually leads to death or severe disability. The JC virus is harmless in most people (in fact, most of us have already been exposed before the age of 10), but can cause PML in those with weakened immune systems.

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Another MS drug – Tysabri, produced by Biogen IDEC – is associated with a higher risk of PML. However, this particular patient had not received that drug. But he had received multiple courses of intravenous corticosteroids plus other drugs such as interferon beta-1a and azathioprine.

Novartis has issued a statement saying that it “considered the infection unlikely to be attributable to Gilenya and had informed the FDA of the infection in July.” The company notes that atypical brain lesions were observed to be present in the patient before treatment with the drug.

At this time, the FDA does not recommend patients discontinue use of Gilenya without first talking with their healthcare provider. The agency is working with Novartis to fully evaluate Gilenya and is providing this alert while continuing to investigate the PML case. Health care professionals and patients should report side effects involving Gilenya to the FDA MedWatch program.

Reference: The US Food and Drug Administration

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