CellCept is a drug that is currently under clinical trials to treat patients who have severe Interstitial Cystitis. Jill, the founder of the Interstitial Cystitis Network, is asking anyone who is taking this drug or who is involved in a study using this drug, to visit the website in the link below and provide the information to your doctor. This drug can be very dangerous for women of childbearing age.
MedWatch 2007 Safety Information Alerts
The FDA and Roche notified healthcare providers that the 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 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.
For some Interstitial Cystitis patients, CellCept has proven beneficial to their symptoms but now they are being taken off the drug due to this news. It’s sad that when patients with severe IC finally find something that gives them some relief it is too dangerous to take. Hopefully something else is in the works to treat these patients who are resistant to the common treatments for IC.