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Study Shows Multiple Sclerosis Drug Tysabri May Lead to Potentially Fatal Brain Infection

Filed February 1st, 2016 F.A. Kelley

A research report published in Neurology: Neuroimmunology and Neuroinflammation on January 27, 2016, indicates that patients taking the genetically engineered multiple sclerosis (MS) drug Tysabri (natalizumab) have a higher risk of developing a potentially fatal brain infection than patients receiving other treatments.

Tysabri is used to treat patients with relapsing multiple sclerosis, the most common form of the disease, but the team of German and French researchers found that the drug may cause a ten-fold risk of developing antibodies to the JC (John Cunningham) virus, Newsday reports. The JC virus may lead to a potentially fatal brain disorder known as progressive multifocal leukoencephalopathy (PML). Tysabri is linked to an estimated 600 PML cases nationwide, with a 23 percent mortality rate.

The researchers report that, in people taking natalizumab, a higher percentage of blood tests changed from negative to positive than for people not treated with natalizumab. The National Multiple Sclerosis Society explains that having a positive antibody test for the JC virus indicates that the person has a higher risk of PML than a person who tests negative, but a positive antibody test does not mean that a person already has or will get PML.

When an individual has MS, the immune system attacks the protective coating (myelin) surrounding nerve fibers, damaging them and causing the patient to lose vital functions and suffer weakness. Symptoms may include dizziness and vertigo, vision problems, muscle spasms, and bowel and bladder problems. There is no cure for MS. Tysabri, made by Biogen, is administered intravenously once a month to help ward off MS attacks.

Doctors say that Tysabri remains a good treatment option for many patients, though it may be necessary to increase routine screenings for the JC virus. Dr. Patricia K. Coyle, director of the Stony Brook University Hospital’s MS Comprehensive Care Center and vice chair of neurology, said, “Whenever you manipulate the immune system, then theoretically the person may be at risk for PML.” She said if any of her patients develop elevated antibody levels, she would consider other medications, according to Newsday. But Dr. Coyle would continue Tysabri for patients who are helped by the drug and who remain free of the JC virus antibodies.

The researchers explain that Tysabri helps the virus breach the blood-brain barrier and cause PML. The symptoms of PML are diverse, depending on the location and amount of damage to the brain. Symptoms may evolve over the course of weeks and months. Symptoms usually include clumsiness; progressive weakness; and visual, speech, and sometimes, personality changes. The progression of symptoms frequently leads to disability and sometimes death, according to the National Institute of Neurological Disorders and Stroke.

The National Multiple Sclerosis Society indicated that Tysabri is one of several medications that help patients who experience episodic attacks of multiple sclerosis. Arney Rosenblatt, spokeswoman for the society, said, “If you are taking this medication, you need to be diligent about following the directions.”

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