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Myfortic News

Kidney Woes Tied to Raised Cancer Risk, Study Finds

Posted 12 Nov 2015 by

THURSDAY, Nov. 12, 2015 – Kidney failure and having a kidney transplant may increase the risk for certain types of cancer, a new study suggests. Poor kidney function and immune system-suppressing drugs may be behind this increased risk, according to Elizabeth Yanik, of the U.S. National Cancer Institute, and colleagues. For the study, published in the Nov. 12 online edition of the Journal of the ...

Kidney Transplant Rejection Drugs Tied to Pregnancy Risks in Study

Posted 23 Oct 2013 by

WEDNESDAY, Oct. 23 – Drugs meant to reduce the risk of organ rejection may increase the risk of miscarriage and birth defects when taken by female kidney transplant patients, according to a new study. The drugs – called mycophenolic acid products – reduce the risk of organ rejection by suppressing the immune system. The study included 163 female transplant patients who discontinued ...

FDA Medwatch Alert: Myfortic (mycophenolic acid) - March 24, 2009

Posted 24 Mar 2009 by

[UPDATE 03/24/2009] FDA and Novartis notified healthcare professionals of the introduction of a Myfortic Medication Guide to provide important safety information in language that patients can easily comprehend. By May 15, 2009, a copy of the Myfortic Medication Guide will be enclosed with every Myfortic bottle. Pharmacists are required to distribute a copy of the Medication Guide with every ...

FDA Medwatch Alert: Myfortic (mycophenolate acid)

Posted 1 Jul 2008 by

[UPDATE 07/01/2008] Novartis informed healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the Myfortic prescribing information. The changes are based on postmarketing data regarding cases of Progressive Multifocal Leukoencephalopathy (PML) in patients treated with Myfortic.[UPDATE 06/26/2008] Roche Laboratories informed healthcare professionals of changes to the ...

FDA Medwatch Alert: Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic)

Posted 16 May 2008 by

[Posted 05/16/2008] FDA is aware of reports of infants born with serious congenital anomalies, including microtia and cleft lip and palate, following exposure to mycophenolate mofetil (MMF) during pregnancy. MMF, the active drug substance in CellCept, is an ester of the active metabolite mycophenolic acid (MPA), the active drug substance in Myfortic. In most cases, the mothers were taking MMF ...

FDA Medwatch Alert: Myfortic (mycophenolic acid) Delayed Release Tablets

Posted 27 Nov 2007 by

[Posted 11/27/2007] Novartis and FDA informed healthcare professionals and patients that use of Myfortic Delayed- Release Tablets during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. The pregnancy category for Myfortic has been changed to Category D (Positive evidence of fetal risk). This change is a result of postmarketing data from the United ...

FDA Medwatch Alert: Immunosuppressant Drugs: Required Labeling Changes

Posted 14 Jul 2009 by

Sirolimus (marketed as Rapamune), Cyclosporine (marketed as Sandimmune and generics), Cyclosporine modified (marketed as Neoral and generics), Mycophenolate mofetil (marketed as Cellcept and generics), Mycophenolic acid (marketed as Myfortic)   The FDA is requiring the makers of certain immunosuppressant drugs to update their labeling to reflect that immunosuppressed patients are at ...

FDA Medwatch Alert: CellCept (mycophenolate mofetil), Myfortic (mycophenolate acid)

Posted 10 Apr 2008 by

[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 ...

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Dermatomyositis, Rejection Prophylaxis

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