Roche's CellCept linked to risk of pregnancy loss.

Roche and FDA Oct. 29 notified health care providers that use of CellCept 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 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, 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 perimenopausal woman) taking CellCept must receive contraceptive counseling and use effective contraception.

Health care 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. www.fda.gov/medwatch/safety/2007/safety07.htm#Cel

Read the complete MedWatch 2007 Safety Summary including a link to the Dear Healthcare Professional Letter and revised prescribing information, at: www.fda.gov/medwatch/safety/2007/safety07.hytm#Cel lCept2.