CellCept Warning Label Updated for Progressive Multifocal Leukoencephalopathy (PML) Risks
June 30th, 2008 amy
According to a letter sent to healthcare providers, cases of Progressive Multifocal Leukoencephalopathy (PML), sometimes fatal, have been reported in patients treated with CellCept. PML is a disease of the central nervous system which usually leads to death or severe disability.
The letter states that on July 8, 2007, Roche searched its global safety database for CellCept cases potentially associated with PML and found ten confirmed cases, plus seven possible cases. Of the seventeen cases, seven had a fatal outcome. Five improved, and five had an unknown outcome.
CellCept is used in organ transplants to help the patient’s body not reject the new organ.
