November 27, 2007 – The U.S Food and Drug Administration (FDA), the equivalents of the Saudi Food and Drug Authority (SFDA), announced that Novartis issued a Dear Healthcare Professional Letter to inform them 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 postmarketing data from the United States National Transplantation Pregnancy Registry and additional postmarketing 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.

Myfortic® (mycophenolic acid) delayed-release tablets are indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids.

Myfortic® (mycophenolic acid) delayed-release tablet IS REGESTERED IN Saudi Arabia.

Actions that Public and Healthcare professionals should follow:

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.

Female patients of childbearing potential must receive contraceptive counseling and must use effective contraception while taking Myfortic.

Report Adverse Drug Reactions to the Saudi FDA

The public and health professionals are encouraged to report adverse drug reactions of Myfortic® to the National Pharmacovigilance center on the internet at: