(15-04-2008) The FDA is investigating a potential link between CellCept® (mycophenolate mofetil) and Myfortic® (mycophenolic acid) and the development of progressive multifocal leukoencephalopathy (PML), a rare life-threatening neurological disorder, usually occurs in immunocompromised patients. It attacks the brain and central nervous system and is usually fatal. Symptoms include vision problems, loss of coordination and memory loss. Patients who survive are often permanently disabled, according to the FDA. Cellcept® is used to avoid rejection in organ transplant patients. The disorder was also seen in patients taking the drug for a form of lupus, a use that is not approved by regulators.
Roche Company, the drug maker, alerted the regulators about this association last November 2007. According to company spokesman, Roche has independently confirmed 10 cases of the disease in CellCept patients, He added that the drug has been used by an estimated 500,000 patients worldwide.
On the other hand, The Food and Drug Administration has identified 16 cases of patients developing this rare neurological ailment while taking Roche's drug CellCept, The agency said it will take about two months to review the reports and approve new labeling for the medications. Until then, regulators advise doctors and patients to watch for symptoms of neurological problems.