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CellCept Label Changed to Reflect Risk of PML

Jun 30, 2008 | Parker Waichman LLP

The maker of CellCept, Swiss Drug Maker Roche, has informed healthcare providers that it has modified the "Warnings" and "Adverse Reactions" sections of the CellCept prescribing information to include information on its association with several cases of Progressive Multifocal Leukoencephalopathy (PML).

CellCept—generically known as mycophenolate mofetil—is part of a class of drugs called immunosuppressants and was approved in 1995 to prevent rejection of solid organ transplants, including kidney, heart, and liver. When CellCept is used  with cyclosporine and corticosteroids, it greatly reduces the patient’s immune system from attacking the transplanted organ. As with all immunosuppressants, CellCept carries certain risks, including development of lymphoma and other malignancies and is also linked to an increased risk of developing opportunistic infections and sepsis.

PML attacks the brain and central nervous system and is usually fatal. Symptoms include vision problems, loss of coordination, and memory loss. According to the FDA, patients who survive the disease are often permanently disabled.  In April, the Food & Drug Administration (FDA) announced that it was reviewing the safety of CellCept due to a possible association with PML.  At the time, Roche said that it had confirmed 10 cases of PML in CellCept users.

PML is associated with at least one other drug, Tysabri, which is used to treat multiple sclerosis. Tysabri was actually removed from the market for a short time in 2005 because several patients taking it had died of the disorder.  In 2005, the law firm of Parker Waichman LLP filed suit against Elan Inc. and Biogen Idec, the makers of Tysabri, on behalf of a woman who died from progressive multi-focal leukoencephalopathy while taking that drug.  When contacted, Jerry Parker, the managing partner of Parker Waichman said that Tysabri case had been resolved, but that the resolution remained confidential.

Last October, CellCept was linked to miscarriage and birth defects, prompting the FDA to add a new boxed warning to its label last November. That labeling remains under FDA review. The potential for side effects was considered so great that the FDA advised women of childbearing age to use two methods of birth control before, during, and after CellCept treatment. The FDA reposted that warning in May.


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