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First trimester use of the organ rejection drug CellCept is linked to an increased risk of spontaneous abortion and fetal birth defects, according to a Food and Drug Administration announcement.
CellCept, a Roche Holding AG drug, gained FDA approval in 1995 to prevent organ rejection in heart, kidney, and liver transplant patients. The company estimates that more than 450,000 patients have been treated with the drug since its approval.
Data Highlights Risks
According to the recent FDA warning, CellCept increases the risk of ear and facial deformities as well as organ and limb problems in babies whose mothers are treated with the drug during their first trimester of pregnancy.
Post-marketing data from between 1995 and 2007 shows that 25 out of 77 women exposed to CellCept suffered a spontaneous abortion and an additional 14 had a baby with a deformity.
The FDA said a new warning was added to the drug about the heightened risk of fetal defects. The agency added that the drug should not be used in women unless pregnancy is ruled out within a week of therapy.
(Source: Reuters)
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