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Cellcept® Birth Defects

CellCept® has been linked to an increased risk of birth defects. The drug is a relatively new immunosuppressant medication approved by the FDA for the prevention of organ transplant rejection. Unfortunately, a significant number of CellCept®-treated women have given birth to babies with severe birth defects.

CellCept®’s Maker Acknowledges the Birth Defects Risk

Roche, the pharmaceutical company that markets CellCept®, has acknowledged that the drug may cause birth defects. The company received FDA approval for CellCept® in 1995, but years later, Roche reported that of 77 CellCept®-treated women studied, 25 suffered miscarriages and 14 had deformed babies or fetuses.

The types of birth defects suffered by babies of women who were treated with CellCept® include abnormalities of the:

heart
esophagus
kidneys
external ear
face
lips and palate (i.e., cleft lip and cleft palate)
limbs

Some of these birth defects are life-threatening, and others can cause permanent disability or disfigurement. Additionally, many congenital defects will cause a fetus to miscarry. CellCept® has been linked to a significant risk of miscarriage.

The FDA Upgraded the Risk Category of CellCept®

In October 2007, a warning about CellCept® was issued by the U.S. Food and Drug Administration. The warning to patients and physicians stated that CellCept® use can cause birth defects or other serious side effects. The FDA required a new, stricter and more obvious warning on the CellCept® packaging regarding the risk of CellCept® birth defects.

The risk category of CellCept® had been Category C, which indicates that “the risk of fetal harm cannot be ruled out” when CellCept® is used. Now, CellCept® is a Category D drug, meaning that there is “positive evidence of fetal risk.”

According to the FDA, women of childbearing age must receive contraceptive counseling and must use effective contraception when being treated with CellCept®.

Consult an Attorney about CellCept® Birth Defects

If CellCept® treatment harmed your baby or you, learn about your legal rights and options. Contact a law firm today that deals with defective drug cases.

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