TenderPoints - WARNING about Rituxan & Lupus

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

 

FDA and Genentech informed healthcare professionals of important emerging

safety information about Rituxan.  Two patients died after being treated with

Rituxan for systemic lupus erythematosus (SLE).  The cause of death was a viral

infection of the brain called progressive multifocal leukoencephalopathy (PML)

that is caused by reactivated JC virus which is present in about 80 percent of

adults.

 

Rituxan is approved for the treatment of CD20-positive, B-cell, non-Hodgkins

lymphoma and for moderately-to-severely-active rheumatoid arthritis when there

has been inadequate response to other treatments and is prescribed off-label

for other serious diseases and conditions such as SLE.  Physicians should

maintain a high index of suspicion for the development of PML in patients under

treatment with Rituxan.

 

Read the complete MedWatch Safety summary, including links to the FDA's

Public Health Advisory, Healthcare Professional Sheet and Drug Information Page

at:

http://www.fda.gov/medwatch/safety/2006/safety06.htm#Rituxan