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Roche's CellCept linked to risk of pregnancy loss.(Warnings/Recalls)(Roche Holding Ltd.)(Brief article)
- Article from:
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Adverse Event Reporting News
- Article date:
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November 5, 2007
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Copyright informationCOPYRIGHT 2007 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Roche and FDA Oct. 29 notified health care providers that 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 post-marketing data from the United States National Transplantation Pregnancy Registry and additional post-marketing 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 ...