Cancer Drug Rituxan Linked to Deadly Brain Infections

Rituxan, the brand name for the cancer-fighting drug rituximab, has been linked to dozens of cases of a swift and deadly brain infection, according to newly released research.

A total of 57 cases of progressive multifocal leukoencephalitis (PML) in patients taking Rituxan for treatment of lymphoma have been reported from 1997 to 2008, according to a new study from the Northwestern University Feinberg School of Medicine RADAR project.

Rituxan is most often given to treat patients with lymphoma, a cancer of the immune system, but it also is approved for treating rheumatoid arthritis and is widely used “off-label” to treat multiple sclerosis, lupus, and autoimmune anemias.

The drug has long been among a list of known PML-causing drugs, including Raptiva and Tysabri, which treat a variety of diseases and conditions by lower the autoimmune system. Doing so can leave patients more susceptible to developing PML and other life-threatening infections.

Raptiva was pulled from the United States market in April 2008 because of the risks of PML. Tysabri also was recalled soon after its 2004 launch but later was allowed back in circulation after more than a year when stricter warnings about the risk of PML were added to the drug’s labeling.

The results of the new Northwestern study are published in the journal Blood.

It is not know how Rituxan may lead to PML or which patients may be most at risk. Researchers said about 1 in 4,000 patients with lupus taking Rituxan will develop PML. While scientists have known that patients with lymphoma are at increased risk of PML regardless of which drugs they take, they were surprised to learn that patients with lupus and rheumatoid arthritis were at greater risk after taking low doses of Rituxan.

Rituxan is a “magic bullet” for the treatment of lymphoma, but as its use expands into other conditions, physicians must carefully evaluate the risks and benefits of the therapy, researchers said.

Patients taking Rituxan should notify their healthcare provider if they develop neurological symptoms such as forgetfulness, disorientation, or mood changes, researchers said.

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