FDA ALERT [12/18/2006]

This Alert highlights important emerging safety information about Rituxan. Two patients have died after being treated with Rituxan for systemic lupus erythematosus (SLE). The cause of death was a viral infection of the brain called progressive multifocal leukoencephalopathy (PML) that is caused by reactivated JC virus. Latent JC virus is present in about 80 percent of adults.

Rituxan is a powerful immunosuppressant that eliminates mature circulating B-cells for up to nine months. Rituxan is approved for CD20-positive, B-cell, non-Hodgkins lymphoma and for moderately-to severely-active rheumatoid arthritis when there has been inadequate response to other treatments. Rituxan is being studied for other indications, and is prescribed off-label for other serious diseases and conditions such as SLE. The sponsor estimates that approximately 10,000 patients with SLE have been treated with Rituxan. Reactivation or exacerbation of viral infections including JC virus leading to PML may occur when patients receive Rituxan for any reason. FDA is working with the sponsor to gather additional information about the occurrence of PML in patients treated with Rituxan and to strengthen the Warnings about the risk of PML in the product labeling for Rituxan. Patients who have been treated with Rituxan and present or develop new neurological signs or symptoms should be evaluated for PML.

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.