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Two Lupus Patients Die After Rituxan Therapy

Treating systemic lupus erythematosus patients with the drug may increase risk of fatal viral infection

WEDNESDAY, Dec. 20 (HealthDay News) -- The U.S. Food and Drug Administration has issued a warning on a potentially life-threatening side effect of using Rituxan to treat systemic lupus erythematosus after it received reports of two fatal cases of progressive multifocal leukoencephalopathy (PML) in such patients.

Rituxan has been on the market since 1997 and is approved for the treatment of non-Hodgkin's lymphoma and rheumatoid arthritis in cases that have stopped responding to other treatments. It decreases production of some types of white blood cells, making patients more susceptible to infection.

To date, the FDA has received reports of 23 cases of PML in Rituxan patients with lymphoid malignancies, most of whom were also on other drugs that affect immunity. The condition can occur after treatment with Rituxan has been stopped -- cases have been reported a year after completion of treatment with the drug.

"Rituxan is used in both approved and off-label settings, and therefore it is very important for prescribers as well as patients to be aware of these new reports of the risk of PML," said Steven Galson, M.D., M.P.H., director of the FDA's Center for Drug Evaluation and Research. "Patients who are being treated or have been treated with Rituxan who experience any major changes in vision, balance or coordination, or who experience confusion, should promptly call their doctor."

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