Myfortic – increased risks of pregnancy loss

The FDA said it has been determined the medication Myfortic is associated with increased risks of pregnancy loss and congenital malformations. Officials said the pregnancy category for Myfortic has been changed to Category D — positive evidence of fetal risk.

Myfortic manufactured by Novartis Pharmaceuticals, is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids.

The FDA said a transplant patient planning a pregnancy shouldn’t use Myfortic unless she cannot be successfully treated with other immunosuppressant drugs.