Yesterday the FDA announced warning label changes for anti-rejection medication, CellCept, used after organ transplants. The new boxed warning claims that the drug may pose a significant risk to pregnant women. The drug can be associated with an increased risk of pregnancy loss within the first trimester and increased risk of abnormalities and birth defects. The FDA warns of many possible congenital malformations, especially facial abnormalities like cleft lip or palate and external ear defects. The FDA also attributes an elevated risk of anomalies in the formation of vital internal organs. CellCept has been placed in a new category (D) of drugs that show “positive evidence of fetal risk.”
The FDA also warns that CellCept can make birth control medication less effective and women of childbearing age should exercise great care when using an oral contraceptive in conjunction with CellCept. Women should have a negative pregnancy test within a week of beginning a CellCept regimen and should also should receive contraceptive counseling and use effective contraception.
FDA approved the drug in 1995 to prevent organ rejection in patients who have had kidney, heart or liver transplants. Roche estimated that 459,000 men and women have been exposed to the drug since then.
For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.