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CellCept® is a drug approved by the FDA in 1995 for the prevention of organ-transplant rejection. Made by the pharmaceutical company Roche, CellCept® is available as tablets, an oral suspension, and for intravenous use. The generic name of CellCept® is mycophenolate mofetil (MMF).

An Immunosuppressant Medication

CellCept® is an immunosuppressant medication, which means that it is given to deliberately suppress the activity of the patient’s immune system. This is done so that the patient’s immune system will not “attack” and reject the newly transplanted organ.

More than 500,000 people have been administered CellCept® in the U.S.

CellCept®’s Deadly Side Effects

Although CellCept® markedly decreased the rate of acute rejection in solid transplant recipients, its use has been accompanied by a number of unexpected and extremely serious side effects.

Miscarriages and Birth Defects

After the introduction of CellCept® in the U.S., it was found that CellCept® can cause both miscarriages and birth defects. In late 2007, the FDA required a new warning on the CellCept packaging about this risk and the agency upgraded the risk category of CellCept® from Category C (risk of fetal harm cannot be ruled out) to Category D (positive evidence of fetal risk).

Women who are to be treated with CellCept® are now advised to use a contraceptive before, during and after their CellCept® treatment. This warning comes too late for many CellCept® patients, however. Many CellCept®-treated women have had either miscarriages or babies with defects such as abnormalities of the:

• external ear
• lips and palate
• distal limbs
• heart
• esophagus
• kidneys

CellCept® and PML

In April 2008, the FDA finished its safety review concerning the link between CellCept® and progressive multifocal leukoencephalopathy (PML), a disease that can leave a patient with irreversible nerve damage or permanent disability. PML can also be fatal.

If CellCept® has harmed you or a member of your family, contact a law firm that represents individuals harmed by defective drugs and make sure your legal rights are protected.

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