Medication Label Change Alert

November 27, 2007

ISSUE:	FDA strengthens the Label Warnings for delayed-release mycophenolate tablets due to increased risk of fetal harm if used during pregnancy
MEDICATION:	Myfortic® (mycophenolate) 180mg or 360mg delayed release tablets

The following was posted on FDA Med Watch alert website dated November 27, 2007:
"Novartis and 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 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.

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

The full content of the Dear Healthcare Professional Letter can be viewed at:
http://www.fda.gov/medwatch/safety/2007/Myfortic_DHCP_Letter.pdf

Please also refer to the recent RxAmerica Drug Alert article on our website entitled "FDA strengthens the Label Warnings for mycophenolate due to increased risk of fetal harm if used during pregnancy" released on October 29, 2007.