Roche's CellCept raises birth defect risks: FDA

WASHINGTON (Reuters) - The Food and Drug Administration said on Monday the Roche Holding AG organ rejection drug, CellCept, boosts the risk of pregnancy loss in the first trimester and also the risk of congenital malformations.

The FDA said it added a new boxed warning to the drug's label about the increased fetal risk of ear and facial deformities and problems in limbs, the heart and other organs. Data collected from a national registry led to the new warning, the FDA said.

CellCept should not be given until a negative pregnancy test is confirmed within one week prior to therapy, the FDA said. The drug may reduce the effectiveness of birth control pills, the FDA said.

CellCept is used to help prevent kidney, liver and heart transplant rejection.

The FDA in its warning cited a review of postmarketing data from 1995 to 2007 that found among 77 women exposed to the drug, 25 had a spontaneous abortion and 14 had a deformed infant or fetus.

Because dangerous side effects are reported voluntarily to the FDA, it is difficult to determine how common the adverse outcomes are, the FDA said.

Prehuman studies of the drug did find some signs of fetal defects, the agency said.

(Reporting by Kim Dixon)