Rituxan, manufactured by Genentech USA, Inc. and Biogen Idec, Inc., has been linked to serious, life-threatening brain infection called Progressive Multifocal Leukoencephalopathy (PML).
Rituxan is an immunosuppressant used in the treatment of rheumatoid arthritis, B cell non-Hodgkin’s lymphoma, B cell leukemia, and some autoimmune disorders. The FDA approved Rituxan in 1997 and in 2006, the labeling was updated to warn patients of the risk of developing PML.
What is the problem with Rituxan?
Rituxan was approved by the FDA for treatment of treatment of rheumatoid arthritis and non-hodgkins lymphoma. It has recently become a popular treatment of lupus in as an off-label use. In 2006, the FDA released a public health advisory against the development of Progressive Multifocal Leukoencephalopathy or PML infections after the use of Rituxan. Rituxan suppresses the immune system. By suppressing the immune system, patients are at higher risk of developing infections like PML. Two lupus patients who had been using Rituxan developed and died from PML. There have also been 23 other reports from rheumatoid arthritis and lymphoma patients who have been diagnosed with this brain infection.
Progressive Multifocal Leukoencephalopathy (PML) is a serious, rare and fatal viral disease involving inflammation of the white matter of the brain. The following is a list of signs and symptoms related to Progressive Multifocal Leukoencephalopathy:
- Mental deterioration
- Vision loss
- Speech disturbances
- Ataxia
- Paralysis
- Coma
- Seizures
- Muscle weakness
- Hemiparesis
- Facial weakness
- Dysphasia
- Memory failure
- Cognition failure