Safety Alerts for Human Medical Products > Tysabri (natalizumab): Update of Healthcare Professional Information

Tysabri (natalizumab): Update of Healthcare Professional Information
Audience: Neurological healthcare professionals, patients





[UPDATED Posted 04/22/2011] FDA has updated the Tysabri (natalizumab) Prescribing Information to give new information about the size of the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection, associated with use of Tysabri for the treatment of multiple sclerosis (MS) and Crohn's disease. The update includes new safety information about patients who have taken other drugs that suppress the immune system, who may be at a higher risk for PML. Tysabri, in a class of medications called immunomodulators, has been approved by the FDA for the treatment of relapsing forms of multiple sclerosis since November 2004 and for the treatment of moderately to severely active Crohn's disease since January 2008. The revised label includes a table summarizing rates of PML with Tysabri use according to the number of infusions (how long the drug is taken or duration of exposure) and information on a newly identified PML risk factor.

Read the complete MedWatch 2011 Safety Summary, including the original February 2010 posting and links to the updated Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199965.htm

Safety Alerts for Human Medical Products > Tysabri (natalizumab): Update of Healthcare Professional Information