WASHINGTON The Food and Drug Administration and Novartis have informed health care professionals and patients that if they use the drug Myfortic delayed release, that they could increase their risks of pregnancy loss and congenital malformations.
The drug is used to prevent organ rejections following kidney, liver or heart transplants. It is an immunosuppressant that works by decreasing the activity of certain cells that make up part of the immune system to help reduce the risk of organ transplant rejection.
The pregnancy category for Myfortic has been changed to Category D, due to 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 during pregnancy. MMF is converted to the active ingredient in Myfortic, following oral or intravenous administration.
Healthcare professionals should discuss the risks and benefits of Myfortic as well as alternative immunosuppressant therapy with the patient.