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Rituxan Therapy Linked to Fatal Brain Infection

Aug 14, 2007 | Parker Waichman LLP, LLP

Rituxan, a powerful cancer medication, has been linked to a fatal brain infection called progressive multifocal leukoencephalopathy (PML).  PML is a viral infection for which there is no treatment.   The disease is usually fatal, and at least two patients undergoing Rituxan therapy have died.

According to the Food and Drug Administration (FDA), two patients developed PML after they were given Rituxan as a treatment for systemic lupus erythematosus (SLE).  Rituxan is not approved to treat SLE.  The FDA has only approved Rituxan for the treatment of non-Hodgkin’s lymphoma and for rheumatoid arthritis when other treatments have failed.  Despite the fact that Rituxan is not approved to treat SLE, the FDA estimates that as many as 10,000 SLE patients have received this treatment.

When a drug is prescribed for a condition that it is not approved to treat, this is known as “off-label use”.   This practice is not rare, nor is it illegal.  Once a drug is approved by the FDA, doctors are free to prescribe it in any way they choose.  Drug companies are forbidden from advertising possible off-labels uses, but if a physician asks for information on off-label treatments, the companies are free to provide it.  Currently, hundreds of prescription drugs are prescribed off-label.  Unfortunately, this means that the safety of these drugs in treating non-approved illnesses was never evaluated.

Rituxan is a powerful medication that suppresses the immune system.  Lupus is an autoimmune disease that occurs when the body's tissues are attacked by its own immune system.  Rituxan is used off-label to suppress the immune systems of SLE patients, thereby easing their lupus systems.  But that could come at a price, because suppressing the immune system also leaves patients open to potentially serious infections, like PML.

PML is characterized by the progressive inflammation of the brain.  Patients with PML exhibit neurological symptoms like confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems.  PML gets worse over time, and is usually fatal.  There is no treatment or cure for the disease.

Of the two Rituxan-treated patients who died from PML, one was a seventy-year-old woman.  She received six infusions of Rituxan between 2004 and 2005.  Soon after, she developed vertigo, involuntary tongue biting and problems walking.  An MRI confirmed that the patient had PML, and she died in March 2006.  The second patient, a 46-year-old woman, died in July the same year.  She had received Rituxan three times between 2002 and 2005.  Her symptoms became apparent in April 2006.

In February 2006, the labeling of Rituxan was updated to include information about the risks of patients contracting several viral infections, including PML. The FDA also cautioned physicians who were considering treating a patient with Rituxan for any condition to inform the patient of the risk of developing PML.

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