CellCept to Cary Warning for Progressive Multifocal Leukoencephalopathy

PML Cases Reported

Roche Laboratories has 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.

In April, the Food and Drug Administration 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.

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Published on Jul-1-08