Pregnancy category revised for CellCept

October 31, 2007

Roche strengthens pregnancy risk for mycophenolate mofetil (CellCept).

The FDA has announced a change to the labeling of mycophenolate mofetil (CellCept, Roche) due to postmarketing reports of increased risk of both congenital malformations and first trimester pregnancy loss. In response, the FDA has changed the Pregnancy Category for the drug from Category C (risk of fetal harm cannot be ruled out) to Category D (positive evidence of fetal risk). Changes will be made to the Boxed Warning, Warnings, Precautions, and Adverse Reactions sections of the prescribing information. Women of childbearing potential should have a negative serum or urine pregnancy test within one week of initiating treatment with mycophenolate. In addition, the agency warns healthcare professionals that the drug can reduce blood levels of oral contraceptives and could therefore theoretically decrease their effectiveness. Reports of abnormalities leading to this change came from the U.S. National Transplantation Pregnancy Registry and other sources.

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