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Title: FDA Investigates Reports of PML in Patients Taking Mycophenolate Mofetil and Mycophenolic Acid
URL: http://www.pslgroup.com/dg/21F556.htm
Doctor's Guide
April 10, 2008

ROCKVILLE, Md -- April 10, 2008 -- The US Food and Drug Administration is investigating a potential association between the use of mycophenolate mofetil (CellCept) and mycophenolic acid (Myfortic) -- medicines used to prevent organ rejection -- and the development of progressive multifocal leukoencephalopathy (PML), a life-threatening disease.

Mycophenolate mofetil is approved to prevent heart, liver, and kidney transplant rejection, and mycophenolic acid is approved to prevent kidney transplant rejection. Both agents are used with other drugs to suppress the immune system.

On November 8, 2007, Roche, the maker of mycophenolate mofetil, submitted an evaluation of its PML cases in patients who have received mycophenolate mofetil in addition to other immunosuppressive medicines. Roche also submitted recommendations to the FDA for including information about PML in the prescribing information for mycophenolate mofetil. On March 14, 2008, Roche informed the FDA of the Dear Health Care Professional letter -- Reports of Progressive Multifocal Leukoencephalopathy (PML) in CellCept (mycophenolate mofetil) treated patients -- it issued in Europe on February 18, 2008.

Roche is aware of cases of PML in transplant recipients and patients with systemic lupus erythematosus (SLE), an autoimmune disorder that is sometimes treated with mycophenolate mofetil. However, mycophenolate mofetil and mycophenolic acid are not approved for treating SLE or similar autoimmune disorders.

The FDA is reviewing data submitted by Roche, including postmarketing reports of PML in patients who took mycophenolate mofetil or mycophenolic acid, and the proposed revisions to the mycophenolate mofetil prescribing information. FDA has asked Novartis, the maker of mycophenolic acid, for data on PML cases and to revise the mycophenolic acid prescribing information to include the same information about PML included in the mycophenolate mofetil prescribing information.

FDA anticipates it may take about 2 months to complete its review of the postmarketing reports and the proposed revised prescribing information for mycophenolate mofetil and mycophenolic acid about PML. Healthcare professionals should be aware of the possibility of PML, such as localised neurologic signs and symptoms in the setting of a suppressed immune system, including during therapy with mycophenolate mofetil or mycophenolic acid. Decreasing total immunosuppression may improve the outcome of patients who develop PML.


SOURCE: US Food and Drug Administration

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