CellCept Update
Read the June 2008 FDA Update Regarding CellCept
CellCept (mycophenolate mofetil)
Myfortic (mycophenolate acid)
Audience: Transplantation specialists, infectious disease specialists,
other healthcare professionals
[UPDATE 6/26/08] Roche Laboratories informed healthcare professionals of
changes to the WARNINGS and ADVERSE REACTIONS sections of the CellCept
prescribing information. The changes are based on postmarketing data regarding
cases of Progressive Multifocal Leukoencephalopathy (PML) in patients treated
with CellCept.
[Posted 04/10/2008] FDA informed healthcare professionals that the Agency
is investigating a potential association between the use of CellCept and
Myfortic, medicines used to prevent organ rejection, and the development of
progressive multifocal leukoencephalopathy (PML), a life-threatening disease.
PML is a rare disorder that affects the central nervous system usually occurring
in patients with immune systems suppressed by disease or medicines. FDA is
reviewing data submitted by Roche, including postmarketing reports it has
received of PML in patients who took CellCept or Myfortic, and the proposed
revisions to the CellCept prescribing information. FDA has asked Novartis, the
maker of Myfortic, for data on PML cases and to revise the Myfortic prescribing
information to include the same information about PML included in the CellCept
prescribing information. FDA anticipates it may take about 2 months to complete
its review of the postmarketing reports and the proposed revisions to the
prescribing information. As soon as the review is completed, FDA will
communicate the conclusions and recommendations to the public.
Until further information is available, patients and healthcare
professionals should be aware of the possibility of PML, such as localized
neurologic signs and symptoms in the setting of a suppressed immune system,
including during therapy with CellCept and Myfortic.
CellCept Update 
Additional warning included in the June 2008 FDA update about CellCept
This June 2008 update from the FDA further warns about CellCept
CellCept Possible link: Progressive multifocal leukoencephalopathy and CellCept
FDA says there may be a link between CellCept and PML disease 
