April 10 2008 - Anti-Rejection Drug CellCept Linked to Fatal Neurological Disease

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April 10, 2008 - Last November, Swiss drug maker Roche Labs alerted the FDA about reports of the fatal neurological disease Progressive Multi-Focal Leukoencephalopathy occurring in patients taking its anti-rejection drug CellCept. The drug is used to help the body avoid rejection following organ transplantation.  Now, regulators are trying to determine whether organ transplant drugs made by both Roche and Novartis increase the risk of the disease.  The FDA also said today that it is reviewing similar risks with Myfortic, a drug made by Novartis that is used to prevent kidney transplant rejection.

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

The FDA says that the process of reviewing the reports and considering revised labeling for the drug will take approximately two months. Until then, regulators advise doctors and patients to watch for neurological symptoms.  Progressive Multi-Focal Leukoencephalopathy attacks the brain and central nervous system, producing symptoms including vision problems, loss of coordination, and memory loss. Patients with the disease often become disabled.

Christopher Vancheri, a Roche company spokesman, confirmed 10 cases of Progressive Multi-focal Leukoencephalopathy in CellCept patients, adding that over 500,000 patients have used CellCept since 1995, when it was first approved for use in the United States.

Last October, CellCept was linked to miscarriage and birth defects, prompting the FDA to add a new boxed warning to its label. 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.  Meanwhile, European regulators added language about the neurological disease to CellCept packaging and, this February, Roche sent a letter to European doctors, highlighting the labeling changes.  The letter stated problems were reported in kidney, heart, and lung transplant patients and the neurological disorder was seen in patients taking the drug for a form of lupus, a CellCept use not approved by regulators.

According to the Roche letter, which the FDA posted to its website today, determining the role of the drug in the reports poses some challenges because many patients taking the drug were suffering with other illnesses and also on other drugs, “However, the contributory role of CellCept cannot be excluded.”

A spokeswoman for Novartis said the company is not aware of any instances of the neurological disease in patients taking its drug and plans to cooperate with any labeling changes recommended by regulators.

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