FDA updates Tysabri safety information
(Wall Street Journal) UPDATED 2009-09-21
The U.S. Food and Drug Administration has updated the safety information for the drug Tysabri to take into account the incidence of a rare brain infection. The new information warns patients that the risk of progressive multifocal leukoencephalopathy, or PML, appears to increase as the number of Tysabri infusions increase. For those patients who developed PML, the average number of infusions was 25. However, Tysabri's drugmaker points out that the overall risk for developing PML is still 1 in 1,000 patients.
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