Last November, Swiss drug maker Roche alerted the US Food and Drug Administration (FDA) about reports of a neurological disease—progressive multi-focal leukoencephalopathy—that is often fatal, occurring in patients taking its drug CellCept. CellCept is used to help the body avoid rejection following organ transplantation. Now, regulators trying to determine whether organ transplant drugs made by Roche and Novartis increase the risk of the often-fatal disease. The FDA also said today that it is reviewing similar risks with Myfortic, a drug made by another Swiss drug maker—Novartis—that is used to prevent kidney transplant rejection.
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 in 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.
The FDA announced the process to review the reports and consider revised labeling for the medications takes 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 and is usually fatal. Symptoms include vision problems, loss of coordination, and memory loss. According to the FDA, patients who the disease are often permanently 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 approved in the US.
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. 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.
Roche said it is difficult to sort out the role of its drug in the reports since many patients had other diseases and were taking other drugs. 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.
Progressive multi-focal leukoencephalopathy is associated with at least one other drug, Tysabri, which is used to treat multiple sclerosis. Tysabri was actually removed from the market in 2005 because several patients taking it had died of the disorder. In 2005, the law firm of Parker Waichman Alonso 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.
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