Mycophenolate Mofetil (CellCept) and Mycophenolate Acid (Myfortic) and risk of Progressive Multifocal Leukoencephalopathy - Ongoing Safety Review - Updated
June 30, 2008
FDA informed healthcare professionals of an ongoing analysis of safety data of mycophenolate mofetil (Cellcept) and mycophenolate acid (Myfortic). Roche has made the FDA aware of cases of progressive multifocal leukoencephalopathy (PML) occurring in patients taking mycophenolate products and other immunosuppressive agents. Progressive multifocal leukoencephalopathy is a rare progressive demyelinating disease of the central nervous system. The disorder is caused by activation the JC virus, which is present in most adults. The cause of viral activation of the viral infection is unknown, but usually occurs in patients with a suppressed immune system.
Prescribing information for CellCept and Myfortic have been updated to include information about mycophenolate and PML. This information is included in the Warnings and Adverse Reactions sections of the prescribing information. The manufacturers have written “Dear Healthcare Professional” letters explaining the changes.
Additional information can be found through the following links:
- FDA MedWatch Alert:
- Early Communication about Ongoing Safety Review:
- Dear Healthcare Professional Letter for Cellcept:
- Dear Healthcare Professional Letter for Myfortic:
June 30, 2008; April 11, 2008; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.