FDA announces safety review of two immunosuppressive drugs

WASHINGTON The Food and Drug Administration issued an early communication today stating that an ongoing safety review is taking place about the immunosuppressive medications CellCept by Roche and Myfortic by Novartis.

The drugs have been linked in safety data provided by Roche to progressive multifocal leukoencephalopathy, a sometimes fatal disorder that affects the central nervous system.

Roche has recommended including this information in the CellCept label. The active ingredient in CellCept, mycophenolate mofetil, is metabolized by the body to MPA (mycophenolic acid), the active drug ingredient in Myfortic.

The FDA anticipates taking two months to complete its review of the safety data and the proposed revised labeling for CellCept and Myfortic that includes information about PML.