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CellCept (mycophenolate mofetil), a drug manufactured by the Swiss company Roche Holding AG, is used to prevent organ rejection in kidney, heart, and liver transplant patients. It has also been shown to help keep the new organ healthy when prescribed after the transplant. Some doctors have prescribed it to lupus patients with a low tolerance for chemotherapy. Since its approval by the U.S. Food and Drug Administration (FDA) in 1995, more than 450,000 patients have been treated with CellCept.
After a review in 2007 of data collected since its approval, however, the FDA identified a risk of birth defects associated with the use of CellCept. Adverse outcomes were voluntarily reported, so it is difficult to determine how common CellCept pregnancy problems are. But with 14 out of 77 pregnant women treated with the drug reporting a deformity in their fetus or newborn, and 25 of the 77 reporting a miscarriage, the FDA opted to issue a black box warning on the drug's labeling.
The boxed warning states that there is an "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 abnormalities of the distal limbs, heart, esophagus, and kidney."
In addition to the black box warning, an FDA MedWatch alert to renal, cardiac, and hepatic transplantation specialists as well as to obstetricians, gynecologists and other healthcare professionals was issued, and then updated on November 27, 2007. It announced that CellCept's pregnancy category had been changed from a "C" (risk of fetal harm cannot be ruled out) to a "D" (positive evidence of fetal risk) and recommended that women of "childbearing potential" should have a negative urine or serum pregnancy test within a week of beginning any CellCept therapy.
The alert further advises that patients and healthcare professionals should be aware that CellCept might reduce the effectiveness of the oral contraceptive pill, and that women of childbearing potential taking CellCept should get contraceptive counseling and use effective birth control.
Studies conducted while the drug was being developed revealed an increased risk of birth defects and pregnancy problems in rabbits and rats that had been given CellCept. This begs the question of whether additional research or earlier warnings may have prevented numerous serious and lifelong injuries.
If you or a loved one has suffered an unwanted miscarriage or if you or a loved one's fetus or baby has or had a congenital malformation after CellCept therapy, you may be the victim of a defective product or medical malpractice. If such is the case, you may be entitled to compensation.