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 Mycophenolate: Fetal Risk
The Food and Drug Administration (FDA) has issued an alert about fetal risk in patients taking mycophenolate mofetil (CellCept) or mycophenolic acid (Myfortic) during pregnancy. Both drugs increase the risk of spontaneous abortion in the first trimester and may cause serious congenital malformations in infants of women treated during pregnancy. Malformations may include microtia and cleft lip and palate.
In most cases reported in the FDA alert, mothers were taking CellCept to prevent rejection after an organ transplant. Some were being treated for immune-mediated conditions such as systemic lupus erythematosus and erythema multiforme. Treatment began before the pregnancy and continued for the first trimester or until the pregnancy was discovered.
CellCept is approved in the United States to prevent organ rejection after allogenic renal, cardiac, or hepatic transplant. Myfortic is used to prevent rejection after allogenic renal transplants. These drugs are almost always given with other immunosuppressants.
In later 2007, the CellCept label was changed to pregnancy risk D (evidence of human fetal risk, but potential benefits to mother may warrant use in pregnant women) and to include the risk of early pregnancy loss and congenital malformations. FDA officials say they're continuing to work with drug makers to mitigate the risks of fetal exposure to these drugs.
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