Tysabri and PML

On June 5, 2006, the Food and Drug Administration (FDA) approved an application for resumed marketing of Tysabri (natalizumab) to multiple sclerosis (MS) patients. In February of 2005, Tysabri was taken off of the market because three people had developed progressive multifocal leukoencephalopathy (PML), a serious viral infection of the brain.

Tysabri: Progressive Multifocal Leukoencephalopathy (PML)
Progressive multifocal leukoencephalopathy (PML) is a rare disorder of the nervous system that primarily affects individuals with suppressed immune systems. The disorder is characterized by demyelination or destruction of the myelin sheath that covers nerve cells. The myelin sheath is the fatty covering - which acts as an insulator - on nerve fibers in the brain. To put this in everyday language, the brain deteriorates.

Symptoms of PML include mental deterioration, vision loss, speech disturbances, ataxia (inability to coordinate movements), paralysis, and, ultimately, coma reflecting the multifocal distribution of brain lesions. In rare cases, seizures may occur.

There is no cure for PML, nor is there currently an effective treatment for PML. The course of PML is relentlessly progressive. Death usually occurs between 1 and 4 months after onset, but there have been a number of reported cases with survival for months to years.

Tysabri: Lawyer with Product Liability Lawsuit Experience
If you have been treated with Tysabri (natalizumab) and have developed progressive multifocal leukoencephalopathy (PML), a lawyer at Pritzker | Olsen, P.A., a nationally-recognized law firm, is available for a free consultation. You may reach us toll-free at 1-888-377-8900 or fill in our online consultation form.

Senior partner Fred Pritzker has over 29 years of experience and focuses his practice on complex product liability cases. In recognition of his achievements, other lawyers have selected him for inclusion in the 2005-2006 edition of The Best Lawyers in America. He has written online information on defective medical product lawsuits and clinical trials.

Sources:

Food and Drug Administration (FDA) News Release (http://www.fda.gov/bbs/topics/ NEWS/2006/NEW01380.html)
National Institute of Neurological Disorders and Stroke (http://www.ninds.nih.gov/disorders/pml/pml.htm)

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