FDA warns about CellCept birth defect side effects

By Austin Kirk
Posted October 29, 2007

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Yesterday, the FDA announced that a black box warning will be added to CellCept, indicating that the drug could increase the risk of miscarriages and birth defects if it is taken during pregnancy.  CellCept is commonly given following organ transplants to keep the body from attacking the new organ, but it could also cause serious congenital malformations and pregnancy loss.

>>FDA MEDWATCH: CellCept Birth Defect Warning

CellCept (mycophenolate mofetil) is manufactured by Roche Holding AG.   Following a kidney transplant, heart transplant or liver transplant, CellCept is prescribed to help keep the new organ healthy.  It is  also prescribed by some doctors to lupus patients who are unable to tolerate chemotherapy.

According to statements released by the FDA and Roche, CellCept side effects are associated with an increased risk of miscarriage during the first trimester and an increased risk of birth defects if the baby is carried to term.  Congential malformations could be caused by the drug, especially external ear and facial abnormalities, such as a cleft lip or cleft palate.  Abnormalities of the arms, legs, heart, esophagus and kidney could also be caused by the drug.

The risk of CellCept birth defects was identified by the FDA after a review of data collected since 1995.  The federal regulators found that out of 77 women who received the drug, 25 had a miscarriage and 14 had a deformed infant or fetus.  It is difficult to determine exactly how common the CelCept pregnancy problems are, since all of the adverse outcomes reviewed by the FDA were voluntarily reported.

The manufacturer had reason to suspect that CellCept may cause birth defects, but it appears that they failed to fully research their product and did not provide adequate warnings which could have prevented many serious and lifelong injuries.  Studies done during the development of the drug found an increased risk of pregnancy problems and birth defects among female rats and rabbits given CellCept.

In addition to the boxed warnings required by the FDA, information will be added to the precautions section to indicate that women of childbearing age should use contraceptives for four weeks before starting CellCept therapy and continue it for six weeks after the drug is stopped.  However, it is possible that CellCept could reduce the effectiveness of oral birth control because it reduces blood levels of hormones in the pill.

CELLCEPT LAWSUITS

The lawyers at Saiontz & Kirk, P.A. are reviewing potential CellCept lawsuits nationwide.  If your child or family member was born with a birth defect, or congenital malformations, review the legal options which may be available by requesting a free consultation.