FDA Medwatch Warning on CellCept, have you seen this yet?
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.
[June 2008 -- Dear Healthcare Professional Letter - Roche]
[April 10, 2008 - Communication About an Ongoing Safety Review - FDA]
Previous MedWatch Alerts:
Return to Top | MedWatch Home | MedWatch Safety Info | Online MedWatch Report | Contact MedWatch
|Thread Tools||Search this Thread|
|Thread||Thread Starter||Forum||Replies||Last Post|
|FDA warning about OTC diarrhea drug||Marlene||Drugs and Drug Treatments||5||Thu Oct 11, 2012 11:57 PM|
|changing from cyclosporine to cellcept||julestheo||AA||10||Wed Apr 4, 2012 03:21 PM|
|Exjade FDA warning update||Marlene||Drugs and Drug Treatments||2||Sun Feb 21, 2010 08:22 PM|
|Updated warning for Aranesp and similar drugs||Birgitta-A||Drugs and Drug Treatments||5||Sun Jun 29, 2008 09:20 PM|
|FDA Approves Intravenous Vidaza for MDS||Marrowforums||News and Events||2||Tue Jul 3, 2007 08:41 PM|