New warning - Cellcept & pregnancy

[Guest guest]

FYI...This was posted on the FDA site last week:

CellCept (mycophenolate mofetil)

Audience: Cardiac, renal, hepatic transplantation specialists,

gynecologists, obstetricians, and other healthcare professionals

[Posted 10/29/2007] 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.