LAWSUITS NEWS & LEGAL INFORMATION
CellCept Birth Defects
Roche and the FDA notified healthcare providers that use of CellCept is associated with increased risk of first trimester pregnancy loss and increased risk of congenital malformations.
CellCept is a medication given to people who have received kidney, heart, or liver transplants to help keep their new organs healthy. This immunosuppressant medication does so by helping prevent the body's immune system from perceiving the new organ as a foreign threat and attacking or rejecting it.
Based on 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 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.
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CellCept is a medication given to people who have received kidney, heart, or liver transplants to help keep their new organs healthy. This immunosuppressant medication does so by helping prevent the body's immune system from perceiving the new organ as a foreign threat and attacking or rejecting it.
Based on 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 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.
CellCept in the News
CellCept Legal Help
If you have suffered a miscarriage or your baby was born with a congenital malformation and you were taking CellCept, please click the link below to send your complaint to a lawyer to evaluate your claim at no cost or obligation.Last updated on
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