Serious Side Effect Associated with Rituxan

January 2007

The Food and Drug Administration (FDA) warns of a serious risk associated the drug Rituxan. Two patients that were treated with the drug for systemic lupus erythematosus (SLE) contracted progressive multifocal leukoencephalopathy (PML), a fatal viral infection that attacks the central nervous system.

Rituxan is approved to treat patients with non-Hodgkin’s lymphoma and those with rheumatoid arthritis. Rituxan is not an approved for treatment of SLE, and symptoms of PML appeared up to months after a final dose of Rituxan. The drug’s label was updated in February 2006 to include a risk of serious viral infections, including PML, in patients with lymphoma.

Patients who have been treated with Rituxan and experience changes in their vision, balance, or coordination, or who are confused should contact their doctors immediately.

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Source: “FDA Warns of Safety Concern Regarding Rituxan in New Patient Population.” FDA News. December 18, 2006.