CellCept: Black Box Warning Re Pregnancy

CellCept: New Black Box Warning Regarding Pregnancy

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.

http://www.rocheusa.com/products/cellcept/pregnancy_notice.pdf

http://www.fda.gov/medwatch/safety/2007/safety07.htm

Keywords: APSFA, APS Foundation, antiphospholipid antibody syndrome, lupus, stroke, dvt, pe, thrombosis, clot, migraine, hughes syndrome, miscarriage, america, usa, anticoagulant, heart attack, APS, cellcept, pregnancy, warning

Blood Clots and Blood Clotting Disorders: Key Issues in Diagnosis, Treatment and Prevention

Blood Clots and Blood Clotting Disorders:
Key Issues in Diagnosis, Treatment and Prevention
Saturday, November 10, 2007

This FREE seminar will be of interest to:

• People who have had a blood clot or are at risk
• People with inherited clotting abnormalities
• Family members
• Health care workers
• Anyone wanting to know more about blood clots and wishing to advance prevention, diagnosis and treatment of thrombosis and thrombophilia

Hosted by

The National Alliance for Thrombosis and Thrombophilia in conjunction with the University of Utah and Intermountain Healthcare

Location

University of Utah's Health Sciences Education Building (HSEB) in Alumni Hall room 2110, Salt Lake City, UT

A map of the conference facilities can be found at http://www.conferences.utah.edu/images/pdf/UGHMap.pdf.

Agenda

Click here to download the complete program.

Registration Information

Registration before November 2nd is requested. You may register by sending an e-mail to: nattseminars@yahoo.com or you may RSVP by phone. Please call Kandace Kaylor at 801-408-1682 before November 4th and 801-507-3747 after November 4th. To register.

http://www.nattinfo.org/commandevents.htm#saltlake

Volume 6 of out Newsletter, "Antiphospho...What?" is available for download!

The newest installment of our quarterly newsletter, "Antiphospho...What??" is available for download at this link: http://www.apsfa.org/docs/APSFAVol6Summer2007.pdf

The next volume will be coming out in November, 2007.

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