Warning issued about transplant drugs and miscarriage risk.

FDA May 16 issued information to health care professionals prescribing CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid) to women of childbearing potential on the increased risk of spontaneous abortion during the first trimester of their pregnancy and on an increased risk of birth defects in their infants.

CellCept and Myfortic are immunosuppressive medicines used to prevent organ transplant rejection.

FDA said in its statement that CellCept is prescribed to treat conditions resulting from abnormal activity in the immune system, such as systemic lupus erythematosus (SLE), rheumatoid arthritis or erythema multiforme. However, CellCept is not approved for use in treating those conditions in the United States.

The agency recommends a number of strategies to assist health care professionals in reducing pregnancy-related risks associated with these products. These strategies include confirming that a pregnancy has not occurred and ensuring that patients use effective contraceptive measures. Women taking CellCept and Myfortic and who are planning to become pregnant should also talk with their doctors about the risks involved and whether alternative immunosuppressive agents can be considered.

FDA revised the labeling for both CellCept and Myfortic in November. Information concerning the risk of spontaneous abortion and birth defects was added to the boxed warning.