FDA Alert Regarding Lupus Medication: an HSS Rheumatology Perspective

Progressive Multifocal Leukoencephalopathy (PML) in Patients Treated with Mycophenolate mofetil (CellCept)

On April 10, 2008, the FDA released a safety alert concerning a possible relationship between CellCept (mycophenolate mofetil) and a devastating neurological disease known as progressive multifocal leukoencephalopathy (PML).

This adds to the wide list of associations between PML and immune deficiency of any cause. PML occurs in patients born with immune deficiency, AIDS patients, patients with sarcoidosis, and patients undergoing immunosuppressive treatment for rheumatic diseases (in particular systemic lupus erythematosus) as well as Crohn's disease and multiple sclerosis.  Lupus patients were previously warned about the occurrence of PML after treatment with rituximab.  Recent medical reviews noted the association of PML and rituximab treatment in rheumatic disease patients and concluded that such complications were extremely rare.

View the FDA alert