Roche Holding AG (OTC:RHHBY) organ rejection drug, CellCept, increase the risk of miscarriage and birth defects according to the U.S. Food and Drug Administration. There is also the possibility of congenital malformations.
The FDA has added a new black box warning to CellCept's label about the increased risk of facial and ear deformities and problems in limbs, heart and other organs. The FDA relied on date collected from postmarketing data collected from 1995 to 2007 that found of the 77 women exposed to the drug, 25 had a spontaneous abortion and 14 had a deformed fetus or infant.
CellCept is given to prevent kidney, liver and heart transplant rejection and should not be given to a woman until a pregnancy test is given, and confirmed negative, within one week of the commencement of therapy. It was also found that the drug may reduce the effectiveness of birth control pills. "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" stated the FDA Medical Product Safety Alert.
CellCept has been FDA approved since 1995.
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