Biogen Idec Inc. and Elan Pharmaceuticals Inc., makers of Tysabri, have recently recalled the newly distributed Multiple Sclerosis (MS) drug from the market and sent out warnings to doctors.

In November 2004, Biogen Idec and Elan Corporation received approval from the FDA to market and distribute Tysabri (natalizumab). Only four months later, February 2005, the drug was quickly removed from the market after the FDA received several reports of severe illness and death in patients prescribed Tysabri and Avonex. In several cases, the patient or corpse was allegedly diagnosed with Progressive Multifocal Leukoencephalopathy (PML), a rare brain infection that directly affects the central nervous system. Symptoms of PML are similar to a stroke: headaches, memory loss, speech and vision difficulties, limb weakness, and partial paralysis; the disease leads to coma then to death.

To date, approximately 8,000 patients have been involved in clinical trials or prescribed Tysabri for multiple sclerosis, Crohn’s disease and rheumatoid arthritis. Biogen Idec and Elan Pharmaceuticals hope to redistribute the drug after extensive evaluations of Tysabri and the possible link to PML.

The billion-dollar company, Biogen Idec, based in Cambridge, Massachusetts, also has another MS drug in the news: the bread-winning drug, Avonex, the most widely prescribed Multiple Sclerosis drug in the world with revenues of $1.4 billion in 2004 has recently been linked to increased risk of liver damage and liver failure. For more details about Avonex and the potential Avonex class action lawsuit, visit the [AVONEX LIVER DAMAGE] page.

Tysabri In the News
The FDA has said a possible fifth case of the brain infection that is linked with the multiple sclerosis drug Tysabri has been reported. (June-13-05) [REUTERS]

Biogen Idec Inc.’s multiple sclerosis drug Tysabri produced signs of fatal nerve disease. On February 28th the drug was withdrawn from the market after three fatal cases from progressive multifocal leukoencephalopathy. The U.S. Food and Drug Administration disclosed a possible fourth fatal case in the first week of June. (June-09-05) [BLOOMBERG]