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Cellcept® Progressive Multifocal Leukoencephalopathy (PML)

Cellcept® has been linked to progressive multifocal leukoencephalopathy (PML), a life-threatening condition that affects the central nervous system (CNS). PML is a rather rare disorder; it usually occurs in patients with a compromised immune system, such as AIDS patients. Cellcept® was introduced to the U.S. in 1995, and some patients treated since then with Cellcept® have developed PML.

Progressive Multifocal Leukoencephalopathy

PML occurs when a harmless virus that’s already present in most people reactivates. This virus, Polymavirus JC, is the basis of an infection that destroys white matter (myelin, the substance that covers and protects nerve fibers) at multiple sites in the brain.

Symptoms of PML

Without the protection from myelin, nerve signals can’t properly get to the rest of the body. Symptoms of PML include:

clumsiness
progressive weakness
visual changes
speech changes
personality changes

PML symptoms aren’t the same in everyone, since different, unpredictable areas of the brain are affected in each person. However, the symptoms worsen with time, and PML can cause permanent nerve damage, disability, and death.

The Diagnosis and Prognosis of PML

PML can be diagnosed with the help of a brain biopsy, MRI, and detection of the JC virus in the patient’s spinal fluid. The prognosis for PML is quite grim; the disease usually last for months, and it is estimated that 80% of patients who contract PML die within the first six months after diagnosis.

The FDA’s Review of Cellcept® & PML

In the spring of 2008, the FDA finished its safety review of the post-marketing reports of PML in patients treated with Cellcept®, and the result was that the Prescribing Information for Cellcept® was revised to include a warning about PML.

If you or your loved one contracted PML after Cellcept® treatment, contact a personal injury lawyer today to discuss your legal rights.

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