FDA is advising healthcare professionals about an increased risk of fetal harm when women become pregnant while being treated with the immunosuppressant drugs Cellcept (mycophenolate mofetil) or Myfortic (mycophenolic acid).

Myfortic is approved to prevent kidney transplant rejection. CellCept is approved to prevent heart, liver and kidney transplant rejection. These drugs are also sometimes used to treat immune-mediated conditions such as lupus and erythema multiforme, which are not approved indications.

Taking CellCept and Myfortic during pregnancy increases the risk of spontaneous abortion during the first trimester, and can cause serious congenital malformations, especially external ear and facial abnormalities, including cleft lip and palate. Anomalies of the distal limbs, heart, esophagus, and kidney have also been reported.

Before prescribing these drugs to women of childbearing potential, clinicians should inform them about these risks. They should be counseled about their contraceptive options and must use two effective forms of birth control. In addition, before being started on Cellcept or Myfortic, a woman should have a negative serum or urine pregnancy test within one week before taking the drug.

Warnings about the potential for fetal harm have been added to the labeling for Cellcept and Myfortic. FDA is continuing to work with the manufacturers of these drugs to find ways to further reduce the risks of fetal exposure.

Additional Information:

FDA MedWatch Safety Alert. Mycophenolate Mofetil [MMF] (marketed as CellCept) Mycophenolic Acid [MPA] (marketed as Myfortic) Inosine Monophosphate Dehydrogenase Inhibitors (IMPDH) Immunosuppressants. May 16, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#MMF