Dangerous Drugs - Tysabri

Tysabri is a monoclonal antibody that has proven efficacy in the treatment of two serious autoimmune disorders: multiple sclerosis (MS) and Crohn's disease (CD). In MS, Tysabri was shown to reduce relapses by 67% and slow the progression of disability by 42%. While it is impossible to compare results across different clinical trials, the older generation drugs (interferons and glatiramer acetate) are generally acknowledged to have a 30-35% decrease in relapse rate. Only two older drugs have been shown to decrease the progression of disability, but again only by around 20-40%.

In February of 2005, the FDA issued a public health advisory to inform patients and health care providers about the suspended marketing of Tysabri, or natalizumab, due to two serious adverse events reported with its use. FDA received reports of one confirmed, fatal case and one possible case of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri for multiple sclerosis. PML is a rare and fatal viral disease that causes progressive inflammation of the brain. Although the relationship between Tysabri and PML is not known at this time, because of the rare, serious and often fatal nature of PML, FDA banned the drug from being distributed.

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