Tysabri Label Modified to Include More Brain Infection Data

April 8, 2011

Tysabri, the multiple sclerosis drug marketed by Biogen Idec Inc. and Elan Corp is having its label updated to include new data about the incidence of progressive multifocal leukoencephalopathy, or PML, a rare brain infection. According to a report from The Wall Street Journal, the U.S. Food & Drug Administration (FDA) will be posting a “Drug Safety Communication” on the label changes in the coming days.

The new Tysabri label information includes a table that details the incidence of PML. It also includes information on a newly identified PML risk factor of patients taking certain immune-system suppressing medication prior to taking Tysabri, the Journal said.

PML attacks the brain and central nervous system and is usually fatal. Symptoms include vision problems, loss of coordination, and memory loss. Patients who survive the disease are often permanently disabled.

The data in the newly-added table – current as of January – shows the risk of getting the infection is 0.3 patients per 1,000 when using the drug for less than two years, the Journal said. That rate rises when using the drug for two to three years, to 1.5 cases, but drops to 0.9 cases for the period of three to four years.

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