FDA Reposts CellCept Warning, Pregnancy-Organ Transplant Drug Risk LinkMay 22, 2008 | Parker Waichman LLP
The Food and Drug Administration (FDA) Friday reposted an earlier notice warning that Swiss drug makers Roche and Novartis drugs prescribed for organ transplant recipients could cause miscarriages and birth defects when taken by pregnant women. The FDA also urged doctors to confirm that transplant patients are not pregnant and are using effective contraception, according to AP/Google.com. Roche's CellCept and Novartis' Myfortic are used to help the body avoid rejection following organ transplantation by suppressing the body's immune system.
Last October, the FDA issued its first warning. At the time, agency spokesperson Christopher Kelly said it was concerned that some physicians might not have seen the initial warning. Kelly also said that most of the reported problems affected those women who took CellCept before they realized that they were pregnant. Also, some of the women took the drug for off-label uses—for conditions the drug was not approved to treat—such as rheumatoid arthritis and lupus.
Last November, Roche alerted the FDA about reports of a neurological disease—progressive multi-focal leukoencephalopathy—that is often fatal and was showing up in patients taking CellCept. Now, regulators are trying to determine whether organ transplant drugs made by Roche and Novartis increase the risk of the often-fatal disease. The FDA also said is currently reviewing such risks in Novartis’ Myfortic, used in the prevention of kidney transplant rejection.
The FDA’s initial warning cited National Transplantation Pregnancy Registry data that was published in December 2006 and looked at 24 women exposed to CellCept with a total of 33 pregnancies; 15 resulted in a miscarriage, 18 in live births. Of the 18 live births, four infants had birth defects. According to post-marketing data derived from he Daily Women’s Health Policy Report 10/31/07, which were collected by Roche and involved reviewed 77 women on CellCept, 25 suffered miscarriages and 14 birth defects among fetuses and infants were realized.
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 collaboration 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, which 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 with 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.