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Progressive multifocal leukoencephalopathy (PML) and natalizumab treatment may be part of the same patient's medical history. Natalizumab (under the trade name Tysabri, originally named Antegren) is an antibody that was FDA-approved for the treatment of multiple sclerosis (MS) in the U.S. in 2004, then withdrawn from the market four months later by its manufacturer, Biogen Idec, after three patients treated with Tysabri/Antegren developed progressive multifocal leukoencephalopathy, a rare and fatal brain infection.
Natalizumab was reintroduced to the U.S. market in 2006, with strict controls to monitor the patients for signs of progressive multifocal leukoencephalopathy. It's thought that natalizumab works against multiple sclerosis by decreasing the inflammatory cells' ability to pass through the body's blood–brain barrier and the cell layers lining the intestines. However, this mechanism of action is not yet proven.
Natalizumab was also approved by the FDA in early 2008 for the treatment of moderate-to-severe Crohn's disease, an inflammatory disorder that affects the gastrointestinal tract, with symptoms such as chronic abdominal pain, diarrhea and weight loss. Effective against both Crohn's disease and multiple sclerosis, natalizumab is administered once every four weeks by intravenous infusion.
Although many people with multiple sclerosis asked, successfully, that natalizumab be allowed back on the U.S. market, it must be noted that this treatment has many deleterious side effects in addition to the increased risk of Progressive multifocal leukoencephalopathy. These side effects, described in detail in the 30-page package insert for Tysabri provided to health professionals, include:
The packaging for Tysabri warns that patients who have or have had Progressive multifocal leukoencephalopathy should not be treated with Tysabri. In addition, Tysabri is obtained through a restricted distribution program that is only for individuals willing to enroll in the program.
If you have contracted Progressive multifocal leukoencephalopathy after being treated with natalizumab for multiple sclerosis or Crohn's disease, contact us to speak with a Progressive multifocal leukoencephalopathy attorney to discuss your legal rights. You may be entitled to monetary compensation for your losses.
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