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Rituxan Label Updated After Patient Dies From Brain Infection

Posted by Chrissie Cole
Monday, September 15, 2008 12:15 AM EST
Category: Major Medical
Tags: FDA & Prescription Drugs, Rituxan, Rituximab, Genentech Inc., Rheumatoid Arthritis, Biogen Idec Inc., Defective Drugs, Multifocal Leukoencephalopathy (PML)

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IMAGE SOURCE: © WikiMedia Commons / Progressive Multifocal Leukoencephalopathy (PML) / author: Filip em


Labeling for the drug Rituxan is being revised after a woman who was treated with it died from a brain infection, according to the U.S. Food and Drug Administration (FDA).

Progressive multifocal leukoencephalopathy (PML) is a rare and often-fatal brain infection, where there is inflammation of the brain's white matter.

Rituxan (generic name rituximab), manufactured by Biogen Idec Inc. and Genentech Inc., was first approved by the FDA in 1997 to treat non-Hodgkin’s lymphoma and in 2006 for rheumatoid arthritis.

This is the first reported case of infection in a patient taking Rituxan for the treatment of arthritis, according to the FDA. PML cases have been previously linked in patients taking Rituxan for unapproved uses, including blood cancer.

The woman first developed the infection nearly two years after discontinuing use of Rituxan, the FDA said. Nine months prior to developing the infection she had undergone chemotherapy treatment for cancer.

Biogen Idec first reported the fatal case of PML in July.

Tara Cooper, a Genentech representative, says the risk of developing PML is already listed on the drug’s label.

“The patient had many confounding factors that make it nearly impossible to evaluate the possible role, if any, that Rituxan may have had in contributing to the woman’s death,” Cooper said.

The FDA urges doctors treating patients for rheumatoid arthritis to look for signs of neurological problems in patients taking Rituxan. Genentech’s letter sent to health care providers advises discontinued use of Rituxan in patients who develop PML and notes there is no treatment for the often-fatal infection.

In July Biogen Idec reported two new deaths from PML in European patients taking Tysabri (natalizumab), for the treatment of multiple sclerosis. In 2005, the drug was withdrawn from the market after being linked to the rare brain disease. #


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