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Case ID: 4217 | Drugs / Medical | 03/04/2005
Kahn Gauthier Swick is investigating possible legal actions against Biogen Idec and Elan because of two adverse events reported with the use of Tysabri (Natalizumab). Tysabri is used to treat MS (multiple sclerosis). The FDA received reports of one confirmed death and one possible case of progressive multifocal leukoencephalopathy (PML) in patients taking Tysabri.
Biogen Idec is voluntarily suspending marketing of Tysabri. Biogen Idec is suspending dosing of Tysabri in clinical trials and is notifying patients and investigators of the possible association between Tysabri and PML. The FDA approved Tysabri in November 2004 and works by reducing the frequency of exacerbations in patients with remitting-relapsing MS, which is th emost common form of Multiple Sclerosis, after one year of treatment. Tysabri when added to Avonex reduced the risk of exacerbations by 54% compared to Avonex alone. Tysabri by itself reduced the risk by 66% compared to placebo. These results represent an important and meaningful benefit for patients with MS. At the time of approval, approximately 1,100 patients with MS had received Tysabri for one year or more. Confirmatory studies were required to be carried out to show continued benefit of the drug after two years of treatment. The two cases reported here occurred in patients in the confirmatory studies. No cases of PML were observed during the clinical trials performed prior to approval of Tysabri. Multiple Sclerosis is a disease of the brain and spinal cord caused by an unknown agent that gradually destroys the myelin covering, or sheath, of nerve fibers, resulting in a temporary interruption or disordered transmission of nerve impulses, particularly in pathways concerned with vision, sensation, and the use of limbs; disruption of impulse transmission may cause mild to moderate symptoms (numbness in the limbs to complete and permanent paralysis); onset generally occurs between ages 20 and 40, with symptoms appearing at irregular intervals for years PML or Progressive Multifocal Leukoencephalopathy is a rare, serious, progressive neurologic disease, usually occurring in immunosuppressed patients, often resulting in irreversible neurologic deterioration and death. There is no known effective treatment for PML, although reversing immune system suppression may slow or arrest progression of the disease. If you or a loved one have PML or have died due to taking Tysabri and would like to speak to a lawyer, please call toll free 1-866-467-1400 now, or make a claim on this page. At Lawcash.com, it is our goal to keep you informed about important legal cases, class actions and settlements. Our lawyers offer free legal evaluations in tort cases, class actions, personal injury, and other lawsuits because we are dedicated to helping you resolve your legal complaints. Other Drugs / Medical Cases of Interest A lawsuit filed in Boone County Circuit Court claims that former oncologist James Hueser and 22 physicians shortchanged patients by administering diluted or tainted chemotherapy drugs and charging full price. The former oncologist recently surrendered his license and paid a $1 million fine stemming from accusations of Medicare fraud. 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