A safety review on rituximab identified an association of the drug with a serious adverse event, progressive multifocal leukoencephalopathy (PML), a viral infection of the central nervous system. The product labeling has been updated to reflect this new safety information, and a public health advisory and information for healthcare professionals have been posted on FDA's Web site.
As of December 2006, FDA has received a total of 24 reports of PML in patients who received rituximab treatment.
Source: http://www.fda.gov/cder/dsn/2007_fall/postmarketing.htm#Rituximab
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