CellCept Lawsuits

In November 2007, a black boxed warning was added to the organ transplant medication about an increased risk of birth defects, such as cleft palate, cleft lip and ear deformities, when taken during pregnancy. In June 2008, information was added to the prescribing information about another possible side effect of CellCept, which could lead to a rare neurological disease that is often fatal.

STATUS OF CELLCEPT LAWSUITS: The potential for CellCept litigation is currently being considered. Cases are being reviewed for babies born with malformations and users who developed a neurological condition known as progressive multifocal leukoencephalopathy.

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MANUFACTURER: Roche

OVERVIEW: CellCept (mycophenolate mofetil) is an immunosuppressant medication which is approved for treatment following an organ transplant to help prevent the body from rejecting the organ. It is also often prescribed “off-label” for unapproved uses, such as treating lupus. It is almost always used together with other immunosuppressant drugs.

CELLCEPT BIRTH DEFECT SIDE EFFECTS: In November 2007, a black box warning was added to CellCept about the risk of first-trimester miscarriages and birth defects. Reports have found that women who used the medication and continued taking it into the first trimester face an increased risk of giving birth to a baby with a malformation birth defect, such as:

• Cleft Palate
• Cleft Lip
• Ear Deformities

According to data in the National Transplantation Pregnancy Registry (NTPR), out of 33 pregnant women exposed to CellCept, just under half of the pregnancies (15) resulted in a spontaneous abortion. For those that resulted in a live birth, four out of the 18 babies (22%) had malformations. For post-organ transplant women who were taking other immunosuppressive drugs, the NTPR data indicates only 4-5% off babies were born with structural malformations.

In May 2008, a follow up alert was issued by the FDA to raise awareness of these risks and ensure that doctors were aware that of the risks. For any women with childbearing potential, the FDA has recommended that they abstain from sex or use two forms of birth control for at least four weeks before beginning the treatment and six weeks after the last dose. In addition, doctors should obtain a negative pregnancy test before beginning treatment.

CELLCEPT NEUROLOGICAL SIDE EFFECTS: In April 2008, the FDA issued an early communication about a possible connection between use of CellCept and the development of an often-fatal neurological disease, known as Progressive Multifocal Leukoencephalopathy. In June 2008, information was added to the Warnings and Adverse Reactions section about postmarketing reports.

There have been at least 17 cases of the neurological disorder associated with the use of CellCept, and 7 of those cases resulted in death. The rare disease attacks the brain and central nervous system. In most cases it results in death or severe permanent disabilities. Symptoms of the potential CellCept neurological disease include:

• Vision Problems
• Loss of Coordination
• Memory Loss

CELLCEPT ANEMIA SIDE EFFECTS: In August 2009, Roche announced that the labeling would be updated about a potential CellCept pure red cell aplasia (PRCA) risk. The new warnings came after Roche received 41 instances of PRCA cases, which reduces the precursors of red blood cell, causing bone marrow to cease production. In some cases, reducing dosage or ceasing to use CellCept cured the condition. Symptoms of PRCA anemia include fatigue, lethargy, and abnormal paleness.