Monday, October 29, 2007
FDA: CellCept Linked to Birth Defects
Via the Houston Chronicle/AP:
Government health officials warned doctors and patients Monday that a Roche drug used by organ transplant patients can cause miscarriages and birth defects when used in pregnant women.
Roche's CellCept has shown links to increased miscarriage in the first three months and ear and mouth birth defects in infants, according to a notice posted to the Food and Drug Administration's Web site.
The agency highlights the risks associated with Cellcept in a new boxed warning, the most serious a drug can carry. Updated labeling also stresses that women of childbearing age must use effective contraception while taking the drug. Pregnant women should only use CellCept if they cannot be treated with other immune-system suppressing drugs.