In November 2007, the FDA added a black boxed warning about possible Myfortic side effects which could increase the risk of birth defects and malformations. According to reports, pregnant women using a chemically similar organ transplant medication, CellCept, have delivered babies with injuries such as cleft palates, cleft lips, ear deformities and other structural malformations. In June 2008, information was added to the prescribing information about another potential side effect of Myfortic, which could lead to a potentially fatal neurological disease. Continued
