In October 2007, the labeling for CellCept was updated to include a boxed warning about its potential to cause miscarriages and birth defects. The concern about these side-effects was so great that the Food & Drug Administration (FDA) actually warned women of childbearing age to use two methods of birth control before, during and after 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.
CellCept Linked to Increased Risk of Birth Defects, Miscarriage
In October 2007, the FDA announced that an analysis of data regarding CellCept from the National Transplantation Pregnancy Registry led it to conclude that pregnant women taking CellCept had 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.
CellCept Label Changed to Include Warnings on Miscarriage, Birth Defects
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). The new CellCept labeling now classified the miscarriage and birth defect risk as Category D (Positive Evidence of Fetal Risk). The new CellCept label advises that doctors should warn female patients of childbearing age of the CellCept miscarriage and birth defect risks. It also said that 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 also required women of childbearing age to undergo pregnancy testing within one week of beginning CellCept therapy. The label also said that female patients prescribed CellCept should begin using contraceptives four weeks prior to starting the drug, and should continue doing so for six weeks after treatment with CellCept was ended. The new CellCept label also advised that these patients should use two methods of birth control while taking CellCept. Finally, the new warning advised that a woman planning a pregnancy should not be prescribed CellCept unless other immunosuppressant drugs proved to be unsuccessful in treating organ rejection.