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Thread: 3776 2 Died of Viral Brain Infection After Taking Rituxan to Treat Lupus, FDA Says (Why is this not




3776 2 Died of Viral Brain Infection After Taking Rituxan to Treat Lupus, FDA Says (Why is this not
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 2006-12-28 01:27:56 

  


  

    FDA Warns of Deaths Linked to Rituxan


2 Died of Viral Brain Infection After Taking Rituxan to Treat Lupus, 
FDA Says


By Miranda Hitti
WebMD Medical News


Reviewed By Louise Chang, MD
on Tuesday, December 19, 
2006

Dec. 19, 2006 -- The FDA has issued a public health advisory on 
Rituxan after two lupus patients taking the drug reportedly died of a viral 
brain infection.


Both patients developed progressive multifocal leukoencephalopathy (PML), a 
brain infection caused by a common but usually harmless virus. However, in those 
who contract PML, the infection is usually fatal; there are no effective 
treatments.


Rituxan is a powerful drug used to suppress the immune system. It works by 
blocking the effect of specific immune cells in the blood, known as B cells, for 
up to nine months.


The drug is approved for use only in patients with certain types of cancer, 
called non-Hodgkin’s lymphoma, and for rheumatoid arthritis when other 
treatments have failed. Rituxan is not approved to treat lupus.


However, Rituxan's maker, Genentech, estimates that approximately 10,000 
lupus patients have been treated with Rituxan, according to the FDA.


The FDA is working to gather more information about Rituxan and PML, and to 
strengthen the drug's warnings about PML.


Signs of PML
Patients treated with Rituxan should contact 
their doctor if they experience any warning sign of PML, says the FDA.


Signs of the disease include confusion, dizziness or loss of balance, 
difficulty talking or walking, and vision problems.


These symptoms are also associated with the underlying diseases for which 
Rituxan may be prescribed, making it harder to spot PML, the FDA notes.


The FDA advises doctors considering treating a patient with Rituxan to inform 
that patient about the chance of developing PML.


Patients taking or considering taking Rituxan should be aware of the chance 
of developing PML and ought to discuss it with their doctor, the FDA adds.


Rituxan's labeling was updated in February 2006 to include information about 
reports of several different types of viral infections, including PML, that had 
become active again or worsened in cancer patients taking the drug. 


Source: www.medicinenet.com




  
  

    Comment: Rituxan is a powerful immune suppressing 
      drug approved only to treat few types of cancers and only when other 
      treatments have failed. With such a limited approval, and especially when 
      it is not even approved to treat Lupus, its maker, Genetech estimates that 
      over 10,000 Lupus patients are taking this dangerous drug. The drug label 
      was updated in Feb 2006 for the cancer patients as well, so why is the 
      drug still being used for this off label use? Its manufacturers are making 
      millions of dollars while people are suffering from deadly infections. 
      This once again highlights how the drug companies are more focused on the 
      business than the health of patients. Dr. Rath has been emphasizing this 
      very fact for more than a decade now. You can read more about the 
      pharmaceutical Business with Disease in the News section on www.drrathresearch.org.


 


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