FDA Drug Safety Communication

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FDA Date: 5/29/10

Myfortic (mycophenolic acid) FDA Drug Safety Communication

Communication about an Ongoing Safety Review of CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid)

FDA has completed its review of postmarketing reports of progressive multifocal leukoencephalopathy (PML) in patients who took CellCept and Myfortic. The prescribing information for CellCept and Myfortic now includes information on PML in the Warnings and Adverse Events sections. Roche and Novartis issued Dear Health Care Professional Letters on May 29, 2008 outlining the changes to the prescribing information.

This information reflects FDA's current analysis of available data concerning these drugs. FDA intends to update this document when additional information or analyses become available.

View the full FDA Drug Safety Communication on FDA.gov