FDA Reviews CellCept and Myfortic Safety

The U.S. Food and Drug Administration says it is conducting a safety review involving CellCept and Myfortic, both organ transplant rejection drugs.

The FDA said the use of CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid), both immunosuppressives, might result in development of progressive multifocal leukoencephalopathy, or PML, which usually occurs in patients with suppressed immune systems.

Hoffmann-La Roche Inc., the maker of CellCept, provided a review of safety data to the FDA showing PML is a rare complication of treatment with CellCept. Roche has recommended including that information on the CellCept label.

Signs and symptoms of PML can include vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say and weakness in the legs.

To evaluate the safety concerns, the FDA has asked Novartis, the maker of Myfortic, a similar medication, for data regarding PML.

FDA officials said they are not recommending patients change how they use the medications. However, the agency said consumers and health care professionals should notify the FDA of any complaints or problems associated with the products.

The FDA sad it anticipates taking two months to complete its review of the safety data and the proposed revised labeling.