Monday, December 18, 2006

FDA Warning About Rituxan and Brain Infection

Article in the Wall Street Journal -- FDA Issues Warning For Cancer Treatment, by Heather Won Tesoriero:

Two patients taking a drug commonly used to treat cancer and rheumatoid arthritis died from a rare brain infection, the Food and Drug Administration and the drug's makers warned yesterday in an announcement that instructed doctors prescribing the drug to watch for signs of the problem.

The patients who died were receiving the drug, Rituxan, as a treatment for lupus. Rituxan, sold by Genentech Inc. and Biogen Idec, isn't approved for lupus, though doctors are allowed to prescribe medications as they see fit. The patients contracted viral brain infection known as progressive multifocal leukoencephalopathy (PML).

In a public safety alert, the FDA warned that PML may be a risk for patients taking Rituxan for any reason. And in a letter to health-care professionals, Genentech said that doctors prescribing Rituxan should be on alert, particularly in patients with lupus or certain cancers.


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