CellCept

According to the U.S. Department of Health and Human Services’ Organ Procurement and Transplantation Network, 28,463 people received an organ transplant in 2009, including 2,006 patients in Pennsylvania. Many of those patients were likely prescribed a medication called CellCept, a drug the U.S. Food and Drug Administration (FDA) has linked to a number of serious and fatal side effects.

CellCept is an immunosuppressant drug, or anti-rejection drug, that prevents a patient’s body from rejecting a heart, liver or kidney transplant. Its generic name is mycophenolate mofetil. It can be administered in capsule or tablet form or by injection. When used in combination with cyclosporine (Sandimmune, Gengraf, Neoral) and corticosteroids, the drug reduces the risk that the patient’s immune system will “attack” the transplanted organ.

In 1995, the U.S. Food and Drug Administration approved the use of CellCept, which is manufactured by Swiss drug maker Roche Holding AG. It has been used safely and works in children and adults with kidney transplants, but it is unknown if it is safe and works in children who receive heart or liver transplants. The medication has also been prescribed for lupus patients to help with chemotherapy.

Since it came onto the pharmaceutical market, the FDA has issued a series of “boxed warnings” and revised warnings about CellCept’s potentially harmful side effects.

Miscarriages and birth defects

According to the FDA, women who take CellCept during pregnancy have a higher risk of miscarriage during the first three months (trimester) and a higher risk that their baby will be born with birth defects. The specific defects cited by the FDA include congenital malformations, such as external ear and facial abnormalities (cleft palate and lip) or problems with distal limbs, esophagus and kidney.

In the fall of 2007, the FDA upgraded the drug’s classification from Class C (risk of fetal harm from drug cannot be ruled out) to Class D (positive evidence of fetal risk from drug) after post-marketing data collected worldwide from 1995 to 2007 showed that out of 77 women exposed to CellCept during pregnancy, 25 had miscarriages and 14 had a malformed infant or fetus.

Because the risk of miscarriage and birth defects is so serious with CellCept, the FDA requires that any women who are of capable of pregnancy be given contraceptive counseling. Furthermore, the FDA requires that these women be advised to:

• Take two different forms of contraceptive (because CellCept reduces the effectiveness of oral contraceptives);
• Begin using contraceptives at least four weeks before beginning CellCept treatment and continue using until six weeks after the CellCept treatment;
• Undergo a pregnancy test one week before starting CellCept medication; and
• Avoid using CellCept unless no other immunosuppressant drug is successful if they are planning a pregnancy.

Serious Infections

Because CellCept weakens the body’s immune system, the medication can impact the body’s ability to fight infections, possibly resulting in serious illness or death. Infections the FDA has linked to CellCept are:

• PML (Progressive Multifocal Leukoencephalopathy): This is a potentially fatal brain infection that results from a virus reactivating and destroying myelin, a substance that coats and protects nerve fibers. PML can lead to permanent nerve damage. Symptoms include loss of muscle control, weakness in one side of the body, confusion and apathy. The FDA has required a warning about PML risks since the spring of 2008.
• Viral Infections: Certain viruses living in your body can cause active infections when the immune system is weak. Among these infections are shingles and other herpes infections, such as cytomegalovirus, which causes serious tissue and blood infections, and BK virus infection, which can affect how the kidney works and cause a transplanted kidney to fail.
• Fungal Infections: Yeast and other fungal infections can cause tissue and blood infections. Symptoms can include high fever, cold and flu symptoms, earaches or headaches, painful urination, white patches in the mouth or throat and unexpected bruising or bleeding.

Cancers

According to the FDA, people who take CellCept have a higher risk of getting lymphoma and other types of cancers. Warning signs include fatigue, weight loss, lymph node swelling, brown or black skin lesions and changes in the size and color of moles.

Anemia

According to a revision to the FDA’s box warning in August 2009, a type of anemia called pure red cell aplasia (PRCA) has been identified in patients treated with CellCept in combination with other immunosuppressive drugs. Symptoms include fatigue, lethargy or abnormal paleness of skin.

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