CellCept Gets New FDA Warning on Miscarriage, Birth DefectsOct 29, 2007 | Parker Waichman LLP
CellCept, a drug used to prevent organ rejection after a transplant, has been linked to an increased risk of miscarriage and birth defects. The new findings have prompted the Food & Drug Administration (FDA) to add a new boxed warning to the CellCept label, and Roche Holding AG, the drug’s maker, has sent a letter to physicians informing them of the CellCept risk and labeling changes. The potential for these drug side effects are so great that the FDA is advising women of childbearing age to use two methods of birth control before, during and after their treatment with CellCept.
CellCept, also known by its generic name mycophenolate mofetil, is part of a class of drugs called immunosuppressants. It was approved in 1995 to prevent rejection of solid organ transplants, including kidney, heart and liver. When used in combination with cyclosporine and corticosteroids, CellCept can greatly reduce the chance that a patient's immune system will attack a transplanted organ. However, like all immunosuppressant drugs, CellCept does carry certain risks, including the development of lymphoma and other malignancies. Like other drugs in its class, CellCept is also linked to an increased risk of developing opportunistic infections and sepsis.
A recent analysis of data regarding CellCept from the National Transplantation Pregnancy Registry has led the FDA to conclude that pregnant women taking CellCept have a significantly higher risk of miscarriage during the first trimester, and that their babies are more likely to develop birth defects, including external ear and facial abnormalities such as cleft palate and lip, and problems with the distal limbs, esophagus and kidney. While it was known previously that CellCept could cause problems during pregnancy, the FDA had classified the risk as Category C (Risk of Fetal Harm Cannot be Ruled Out). These side effects are now classified as Category D (Positive Evidence of Fetal Risk).
The FDA is now warning that doctors should tell female patients of childbearing age about CellCept miscarriage and birth defect risks. Women of childbearing age who receive CellCept must be counseled on contraceptive use, and they should be made aware that the drug can interfere with the effectiveness of oral contraceptives.
The FDA is also now requiring women of childbearing age to undergo pregnancy testing within one week of beginning CellCept therapy. A female patient prescribed CellCept should begin using contraceptives four weeks prior of starting the drug, and for six weeks after stopping. The FDA is also advising that female patients of child bearing age use two methods of birth control while taking CellCept. Finally, the FDA is advising that a woman planning a pregnancy should not be prescribed CellCept unless no other immunosuppressant drugs have been successful in avoiding organ rejection.
Finally, to further monitor fetal outcomes of pregnant women exposed to CellCept, a National Transplantation Pregnancy Registry has been established. The FDA is encouraging doctors to register their female CellCept patients by calling 1-877-955-6877.