FDA Reviewing the Scheduling of Rituxan

The Food and Drug Administration (FDA) is reportedly reviewing the frequency with which the cancer agent Rituxan is administered, in light of reports concerning the biologic agent and the development of the fatal brain infection progressive multifocal leukoencephalitis (PML).

Rituxan, known generically as Rituximab, is FDA indicated for treatment of lymphoma, a cancer of immune-system cells, as well as rheumatoid arthritis. Rituximab is also used off-label for treatment of lupus erythmatosus, autoimmune anemias and multiple sclerosis.

In 2006 the labeling for Rituxan was updated to include a black box warning for PML, the symptoms of which include dizziness, confusion, loss of balance, vision problems, and possibly difficulty walking and talking.

A study reported in the journal Blood, in May 2009 that evaluated PML case descriptions among patients treated with rituximab from the FDA, the manufacturer Genentech, physicians, and a literature review from 1997 to 2008, revealed "Overall, 52 patients with lymphoproliferative disorders, 2 patients with systemic lupus erythematosus, 1 patient with rheumatoid arthritis, 1 patient with an idiopathic autoimmune pancytopenia, and 1 patient with immune thrombocytopenia developed PML after treatment with rituximab and other agents." The median time to death following a diagnosis of PML was 2.0 months, with a fatality rate of 90 percent.

JUN-01-09: FDA Weighs the Risks of Rituxan [WSJ: FDA WEIGHS RISKS OF RITUXAN]

Legal Help

If you or a loved one has suffered adverse health effects, or contracted PML as a result of using this drug, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.

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