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Rheumatoid Arthritis Patient Treated with Rituxan Died of PML, FDA Warns

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The Food & Drug Administration (FDA) has warned that a patient being treated for rheumatoid arthritis  with Rituxan died of the brain infection progressive multifocal leukoencephalopathy (PML).  In a letter sent to healthcare providers, Genentech and Biogen Idec, the makers of Rituxan, advised doctors to consider PML in any patient presenting with new onset neurologic manifestations. Consultation with a neurologist, brain MRI and lumbar puncture should be considered as clinically indicated. Rituxan should be discontinued immediately in patients who develop PML, the letter said.

Rituxan is a powerful medication that suppresses the immune system. It was approved to treat rheumatoid arthritis and non-Hodgkins Lymphoma, but is often used off-label to treat other conditions.   In February 2006, the labeling of Rituxan was updated to include information about the risks of patients contracting several viral infections, including PML. The FDA also cautioned physicians who were considering treating a patient with Rituxan for any condition to inform the patient of the risk of developing PML. Last year, the FDA warned that two patients taking Rituxan off-label for systemic lupus erythematosus had died from PML.

This is the first time a patient being treated with Rituxan for rheumatoid arthritis has been known to develop PML.   According to the FDA, the patient -a woman – was undergoing chemotherapy and radiation treatment for cancer in the months before she developed the infection.  The agency said the patient  received Rituxan in a long-term safety extension clinical study. According to the FDA, the patient developed a JC virus infection with resultant PML and death 18 months after taking the last dose of Rituxan.

PML  is caused by a polyomavirus, called the JC virus. The JC virus is often acquired during childhood. Most adults have been infected with the JC virus but do not develop PML. The virus appears to remain inactive until something (such as a weakened immune system) allows it to be reactivated and start to multiply. PML is characterized by the progressive inflammation of the brain and central nervous system. Patients with PML exhibit neurological symptoms like confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems. PML gets worse over time, and is usually fatal. There is no treatment or cure for the disease.

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