Myfortic

Novartis and the FDA informed healthcare professionals and patients that use of Myfortic Delayed-Release Tablets during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. The pregnancy category for Myfortic has been changed to Category D (positive evidence of fetal risk). This change is a result of post marketing data from the United States National Transplantation Pregnancy Registry and additional post marketing data collected in women exposed to systemic mycophenolate mofetil (MMF) during pregnancy. MMF is converted to the active ingredient in Myfortic, following oral or intravenous administration. A patient who is planning a pregnancy should not use Myfortic unless she cannot be successfully treated with other immunosuppressant drugs.

Healthcare professionals should discuss the risks and benefits of Myfortic as well as alternative immunosuppressant therapy with the patient. Myfortic is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids.

Myfortic Legal Help

If you took Myfortic and lost your baby or your baby was born with congenital malformation, please click the link below to send your complaint to a lawyer to evaluate your claim at no cost or obligation.
Published on Nov-28-07