CellCept®

• Home
• Cellcept

Cellcept®

CellCept® is an FDA-approved medication given to patients who have undergone a heart, liver, or kidney transplant. An immunosuppressant drug, CellCept®’s purpose is to help prevent the patient’s body from rejecting the new organ.

Each year in the U.S., about 25,000 people receive an organ transplant, and many receive CellCept® in combination with other ant-rejection drugs.

CellCept® Side Effects
Unfortunately, CellCept® treatment has been linked to a number of severe — even deadly — side effects:

• PML (progressive multifocal leukoencephalopathy), a debilitating and often fatal neurological disease
• miscarriages in pregnant patients treated with CellCept®
• birth defects
• lymphomas (cancers of the lymphatic system)

Adverse Events Reported to the FDA
After the FDA approved CellCept® in 1995, CellCept® began to be used very widely in the U.S. It is estimated that more than 500,000 people have been administered this medication in the U.S. alone.

However, the FDA began to receive many reports of complications from CellCept® treatment that were not described in the original Prescribing Information/Warnings for CellCept®. Over the years, the rate of miscarriage and birth defects linked to CellCept® and gathered by the National Transplantation Pregnancy Registry prompted the FDA to conduct a Safety Review of CellCept®.

CellCept® Warnings
In 2007, the FDA concluded that the CellCept® packaging should be revised to include a warning about CellCept® having caused miscarriages and birth defects. The FDA upgraded the classification of CellCept® from Class C (the risk of fetal harm from a drug cannot be ruled out) to Class D (there is positive evidence of fetal risk from the drug).

Then, in the spring of 2008, the FDA told Roche to revise the CellCept® prescribing information again to warn physicians and patients about the risk of PML presented by CellCept®.

If You’ve Been Harmed by CellCept® Treatment
If CellCept® treatment has harmed you or a member of your family, contact a law firm that represents the victims of dangerous drugs and find out more about your legal rights.