FDA Issues Second CellCept WarningMay 18, 2008 | Parker Waichman LLP
The Food and Drug Administration (FDA) issued another warning Friday that Roche and Novartis drugs prescribed to organ transplant patients can cause miscarriages and birth defects when taken by pregnant women. Birth defects include external ear and facial abnormalities such as cleft palate and lip as well as problems with the distal limbs, esophagus, and kidney. This recent warning was the second in less than two months.
Last October, Roche’s CellCept and Myforic by Novartis labeling were updated to include a boxed warning over the potential for miscarriages and birth defects. The new CellCept labeling classified the risk as Category D (Positive Evidence of Fetal Risk). The concern about side effects was so great that the FDA warned women of childbearing age to use two methods of birth control before, during, and after CellCept treatment.
FDA spokesman Christopher Kelly said it has not received new reports of pregnancy-related problems; however, the FDA reissued the warning over concerns some doctors may not have seen the initial warning. Roche previously reported 25 miscarriages among 77 women exposed to the drug between 1995 and 2007. In a notice posted online Friday, the FDA said that before prescribing the drugs doctors should confirm their transplant patients are not pregnant and are using effective contraception.
Meanwhile, the potential for side effects was considered so great that, in October, the FDA advised women of childbearing age to use two methods of birth control before, during, and after CellCept treatment. This February, Roche confirmed 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. The FDA said most of the problems came from mothers taking CellCept before their pregnancies were detected; some were taking the drug for off-label uses such as rheumatoid arthritis in addition to lupus.
Last month, the FDA said it was investigating 16 patients who developed a rare neurological disease—progressive multifocal leukoencephalopathy—while on CellCept. The disease attacks the brain and central nervous system and is generally fatal with symptoms that include vision problems, loss of coordination, and memory loss. Those who survive are often left permanently disabled.
CellCept is generically known as mycophenolate mofetil and is part of drug class called immunosuppressants. CellCept carries other risks, including the development of lymphoma and other malignancies and is also linked to an increased risk of developing opportunistic infections and sepsis.
Progressive multi-focal leukoencephalopathy is associated with at least one other drug, Tysabri, which is used to treat multiple sclerosis. Tysabri was removed from the market in 2005 after 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—makers of Tysabri—on behalf of a woman who died from the disease 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.