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. See the Dear Healthcare Professional Letter for
additional recommendations for women of childbearing potential.
Read the complete MedWatch 2007 Safety Summary including a link to the
Dear Healthcare Professional Letter and revised prescribing information,
at:
http://www.fda.gov/medwatch