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Rituxan warning issued by FDA

Dec 19, 2006 | North County Times
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Patients Treated with Rituxan may be at Risk from a Rare, Fatal Brain Infection

Patients treated with Rituxan may be at risk from a rare, fatal brain infection, the U.S. Food and Drug Administration warned Monday.

The FDA said it has recently learned of two deaths from progresive multifocal leukoencephalopathy (PML) in patients treated with Rituxan, a drug developed in San Diego by Idec Pharmaceuticals, now merged with Biogen to form Cambridge-based Biogen Idec.

The patients were given Rituxan, for systematic lupus erythematosus, or SLE. Rituxan is not approved to treat this disease. Rituxan is approved for treatment of non-Hodgkin's lymphoma and rheumatoid arthritis. Biogen Idec sells Rituxan in partnership with South San Francisco-based Genentech Inc.

Last year, Genentech suspended sales of another drug, Tysabri, due to reports that two patients taking the drug for multiple sclerosis had contracted PML. The FDA later allowed Tysabri sales to resume, with additional cautionary warnings. Genentech has built a manufacturing plant in Oceanside to make Tysabri. The plant is expected to begin commercial production next year.

Both Rituxan and Avastin belong to a class of drugs called monoclonal antibodies, which are specifically crafted to destroy cells implicated in disease. FDA spokeswoman Karen Riley said she had not heard of anything to suggest a linkage between the reactions.

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