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U.S. Department of Health and Human Services

Safety

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Rituxan (Rituximab)

Audience: Oncologists, Rheumatologists, other healthcare professionals, and consumers

Indication: Treatment of CD20-postive, B-cell, non-Hodgkins lymphoma and for moderately-to-severely-active rheumatoid arthritis when there has been inadequate response to other treatments.

[Posted 12/18/2006] FDA and Genentech informed healthcare professionals of important emerging safety information about Rituxan. Two patients died after being treated with Rituxan for systemic lupus erythematosus (SLE). Rituxan is approved for the above indication and is prescribed off-label for other serious diseases and conditions such as SLE. The cause of death was a viral infection of the brain called progressive multifocal leukoencephalopathy (PML) that is caused by reactivated JC virus which is present in about 80 percent of adults. Physicians should maintain a high index of suspicion for the development of PML in patients under treatment with Rituxan.

[December 18, 2006 - Healthcare Professional Sheet - FDA]
[December 18, 2006 - Public Health Advisory - FDA]
[December 18, 2006 - Drug Information Page - FDA]