The FDA has issued an Early Communication about the possible development of progressive multifocal leukoencephalopathy (PML) in patients taking mycophenolate mofetil (CellCept, Roche) and mycophenolic acid (Myfortic, Novartis). Roche provided safety data to the agency that show that PML is a rare complication of therapy and recommended adding the new information to the product's label. The FDA has since requested any similar data from Novartis on Myfortic before it begins its two-month review of the safety data and proposed revised labeling for the products. In the meantime, healthcare professionals should notify the agency of any compliants or problems with these products by reporting directly to MedWatch. Currently, the FDA is not recommending any changes in how patients use these medications.

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