April 25, 2011 – The Food and Drug Administration has announced additional warnings to be included on the labels and literature regarding the popular drug Tysabri. On April 22nd, the FDA posted new updates to the ongoing investigation of the MS drug Tysabri in connection to development of progressive multifocal leukoencephalopathy (PML). This is a rare but serious brain infection that has been confirmed to have affected 31 patients who took Tysabri as of January 2010. The FDA has revised the label on the drug to include a table that summarizes the rates of PML in connection to Tysabri infusion frequencies. It also includes information about the PML risk factor for doctors and patients to consider when choosing a treatment plan for MS or Crohn’s Disease. Tysabri has been used since November 2004 for the treatment of relapsing forms of MS. In January 2008 it was also approved for treatment of moderate to severe cases of Crohn’s disease. The drug is known as an immunomodulator. If you or a loved one has been treated with Tysabri in the past, or are planning on beginning treatment you should discuss the risks with your doctor. In cases where you or your loved one have already suffered damages from PML due to Tysabri use, a dangerous drug attorney can help review your case and determine if you can file a lawsuit to recover damages.
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