CellCept® Warning
(800) 889-9248
Several CellCept® warnings have been issued since the introduction of the drug in 1995. The updates have included:
- a warning regarding the increased risk of miscarriage
- a warning about its increased risk of birth defects
- a warning about increased susceptibility to infections and possible development of lymphoma
- a warning about progressive multifocal leukoencephalopathy (PML) occurring after CellCept® treatment
CellCept® Warning about Fetal Risk
In 2007, the FDA changed the risk category of CellCept® from Category C to the more severe Category D, warning that CellCept® has shown positive evidence of fetal risk.
The CellCept® Prescribing Information from Roche includes a section about CellCept®’s “Teratogenic Effects,” with data from the National Transplantation Pregnancy Registry. The data show that 22 percent of the live-born infants of the CellCept®-treated women studied had “structural malformations” such as:
- external ear and facial abnormalities
- anomalies of distal limbs
- heart, esophagus, and kidney malformations
The CellCept® warning about its increased miscarriage risk gives similar disturbing numbers. Nearly one-third of the women studied suffered miscarriages.
CellCept® Warning about PML
The Roche Prescribing Information also cites the risk of progressive multifocal leukoencephalopathy (PML) in patients treated with CellCept®. In PML, a virus destroys white matter in some areas of the brain. PML is rare, and it’s considered an AIDS-defining illness; about two to five percent of AIDS patients develop PML. The immunosuppression caused by CellCept® can result in PML and it can be fatal.
Learn More about the CellCept®-Warning Information
If you fear that CellCept® has harmed you or a member of your family, talk to a lawyer who represents the victims of defective drugs and learn more about your legal options.
