Rituxan (rituximab) in rheumatoid arthritis may cause Progressive Multifocal Leukoencephalopathy: FDA Alert

Rituxan was reported to be associated with progressive multifocal leukoencephalopathy (PML). In an alert issued recently by Genentech and FDA, rituximab (Rituxan) was used in a patient with rheumatoid arthritis who has not previously treated with any TNF antagonist. This would be the first case of rituximab-associated PML in rheumatoid arthritis. Previously there have been 2 other rituximab-associated PML cases.

Genentech, the company that produced Rituxan, said that the incident is very low, there were only three cases out 100000. Genentech was trying to expand the use of Rituxan to include earlier stage of rheumatoid arthritis, but FDA has disapproved it due to the recently reported PML.

The FDA said that:
"Physicians should consider PML in any patient being treated with Rituxan who presents with new onset neurologic manifestations. Consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated."