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Rituxan Investigation

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The law firm of Milberg LLP is investigating claims against Genentech Inc. and Biogen Idec Inc. relating to an FDA black box warning and drug advisory informing of the risk of viral infections, including, progressive multifocal leukoencephalitis (PML) associated with the drug Rituxan.

FDA regulators and other medical experts are working to better understand the link between cancer drug Rituxan and PML, a potentially fatal viral infection which affects the brain.  In 2006, the FDA issued a “black box” warning—the most serious warning the FDA can issue—because of an established link between Rituxan use and viral infections, including PML.

Rituxan

Rituxan—marketed by Genentech Inc. and Biogen Idec Inc.—is a drug that causes the immune system to target specific types of cells, which can be desirable in the treatment of immune-related medical conditions.  Rituxan (rituximab) is the most important and commonly used drug used to treat non-Hodgkin’s lymphoma, a cancer affecting the immune and lymph systems.  Rituxan is also approved to treat rheumatoid arthritis and is sometimes prescribed off-label to treat lupus, multiple sclerosis, and autoimmune anemias.

Progressive multifocal leukoencephalopathy (PML)

PML is a progressive and often fatal viral infection which affects the white matter in the brain.  Unfortunately, there is no known treatment or cure for PML at this time.  This infection can produce the following neurological symptoms:

  • confusion
  • dizziness
  • loss of balance
  • trouble talking or walking
  • vision problems

The Study Linking PML and Rituxan

In 2009, a study in the hematology journal Blood reported the details of 57 cases of PML in patients taking Rituxan between 1997 and 2008.  This research found that the average patient who developed PML while taking Rituxan died two months after being diagnosed.

However, many cases of PML were misdiagnosed as either dementia or Alzheimer’s, because these diseases produce symptoms similar to PML.

The patients in the RADAR (Research on Adverse Drug Events and Reports) project were taking Rituxan for treatment of lymphoma, rheumatoid arthritis, or anemia.  According to the researchers, a small percentage of lymphoma patients will develop PML no matter what treatment they receive.  However, PML is not common in arthritis or anemia patients, suggesting a drug link to this viral infection.  Cases of PML have also been found in patients taking Rituxan for systemic lupus erythematosus.

The FDA advises doctors to consider the possibility of PML in any patient taking Rituxan who develops neurological symptoms.

If you or a loved one has used Rituxan and experienced any related problems, or have legal concerns related to this drug, please contact us immediately at (888) 579-1605.  You may be legally entitled to recover medical expenses and lost earnings, as well as compensation for physical pain and suffering, mental anguish, and physical impairment.  For persons who have died, their surviving spouse or other family members often can bring a wrongful death action.

Milberg LLP
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Phone number: (888) 579-1605

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© 2012 Milberg LLP  |  ATTORNEY ADVERTISING. PRIOR RESULTS DO NOT GUARANTEE A SIMILAR OUTCOME.