Use of CellCept (mycophenolate mofetil) associated with increased pregnancy loss and congenital malformations

October, 29th , 2007, US FDA, the American's equivalent to the Saudi Food and Drug Authority (SFDA), Published notification about increased risk of pregnancy loss and increased risk of congenital malformations after using CellCept.

Roche and FDA notified healthcare providers that use of CellCept (mycophenolate mofetil) is associated with increased risk of first trimester pregnancy loss and increased risk of congenital malformations, especially external ear and facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney. Based on postmarketing data from the United States National Transplantation Pregnancy Registry and additional postmarketing data collected in women exposed to systemic mycophenolate mofetil during pregnancy, the pregnancy category for CellCept has been changed from Category C (risk of fetal harm cannot be ruled out) to Category D (positive evidence of fetal risk). Labeling changes include the following sections: BOXED WARNING, WARNINGS/Pregnancy and Pregnancy Exposure Prevention, PRECAUTIONS/Information for Patients, and ADVERSE REACTIONS/Postmarketing Experience.

Within one week of beginning CellCept therapy, women of childbearing potential should have a negative serum or urine pregnancy test. In addition, women of childbearing potential (including pubertal girls and peri-menopausal woman) taking CellCept must receive contraceptive counseling and use effective contraception. Healthcare professionals and
patients should be aware that CellCept reduces blood levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness.

Actions that Healthcare Professionals and Public Should Follow:

· CellCept must not be given in case of pregnancy to avoid any congenital anomalies.

· Women should do pregnancy test before administer CellCept.

· Women of childbearing potential and taking CellCept must receive contraceptive counseling.

· CellCept reduces blood levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness. So, use of an effective contraception is must.

Report Adverse Drug Reactions to the Saudi FDA

The public and health professionals are encouraged to report adverse drug reactions the National Pharmacovigilance Center on the Internet at