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Informs Tysabri (Natalizumab) |
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Tysabri (Natalizumab): Risk of developing progressive multifocal leukoencephalopathy (PML) increases with increasing duration of exposure to Tysabri
Dear Colleague:
The U.S. Food and Drug Administration (FDA) is alerting the public that the risk of developing progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection associated with the use of Tysabri (natalizumab), increases with the number of Tysabri infusions received. This new safety information, based on reports of 31 confirmed cases of PML received by the FDA as of January 21, 2010, will now be included in the Tysabri drug label and patient Medication Guide.
For additional information, including the data summary, please click here to visit FDA's website.
Sincerely,
Janelle Derbis, PharmD
Office of Special Health Issues
Food and Drug Administration
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Last Updated ( Friday, 05 February 2010 )
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