The FDA has issued an alert regarding the increased risk of first trimester spontaneous abortion and fetal congenital malformations with the use of CellCept (mycophenolate mofetil, from Roche) and Myfortic (mycophenolic acid, from Novartis). The FDA has received reports of infants born with microtia and cleft lip and palate, following CellCept exposure during pregnancy. In most cases, the mothers were taking CellCept following organ transplant to prevent organ rejection. However, some mothers taking CellCept were being treated for immune-mediated conditions. Prior to prescribing CellCept and Myfortic to women capable of becoming pregnant, clinicians should provide fetal risk information, counsel and instruction about contraception options, and confirm that the patient is not pregnant.

CellCept is approved to prevent heart, liver, and kidney transplant rejection and Myfortic is approved to prevent kidney transplant rejection.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm092745.htm.