(Cellcept is currently under clinical trials as a treatment for severe IC. If you are taking cell cept or are in any of these studies, please visit the URL below and provide it to your doctors. This is VERY serious for women of childbearing age. - Jill )
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/safety/2....htm#CellCept2
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/safety/2....htm#CellCept2
Comment