The FDA and Novartis have informed health care professionals and patients about a link between delayed-release mycophenolic acid (Myfortic, Novartis) and an increased risk of pregnancy loss and congenital malformations during pregnancy. This medication is indicated for preventing organ rejection in patients receiving allogeneic renal transplants.
The classification of Myfortic has now been changed to Category D, which is characterized by evidence of risk to the fetus. Women who are planning to become pregnant should not use Myfortic unless they cannot be treated successfully with other immunosuppressant drugs. Health care providers are advised to discuss the risks and benefits of Myfortic as well as alternative immunosup-pressant therapy with their patients.
Women of childbearing age should receive contraceptive counseling and must use effective contraception while they are taking Myfortic.
(Sources: FDA, Novartis.)