October 26, 2009
FDA warns of progressive multifocal leukoencephalopathy (PML) with RituxanThe FDA and Genentech have notified healthcare professionals of a third case of progressive multifocal leukoencephalopathy (PML), the first case of PML in a patient with rheumatoid arthritis (RA) treated with Rituxan (rituximab) who has not previously received treatment with a TNF antagonist. PML has been reported in patients with RA, including those treated with other immunosuppressive medications in the absence of Rituxan. Two fatal cases of confirmed PML have been previously reported in patients with RA with possible risk factors for the development of PML, including oropharyngeal malignancy treated with chemotherapy and radiation therapy and/or long standing lymphopenia prior to and during Rituxan treatment.
Healthcare professionals 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.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187791.htm.