Genetech notified healthcare professionals of revisions to the prescribing information on the drug Rituxan after a woman who was treated with it died from a brain infection, according to the Food and Drug Administration (FDA).
Progressive multifocal leukoencephalopathy (PML) is a rare and often-fatal brain infection, where there is inflammation of the brain’s white matter.
The drug was first approved by the FDA in 1997 to treat non-Hodgkin’s lymphoma and in 2006 for the treatment of rheumatoid arthritis.
According to the FDA, this is the first reported case of infection in a patient taking Rituxan for the treatment of arthritis. PML cases have been linked to patients taking Rixutan for unapproved uses in the past, including blood cancer.
Biogen Idec first reported the fatal case of PML in July.