Rituxan FDA Warnings, Recall, Side Effects, Warnings
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Rituxan (rituximab) Genentech-Biogen
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The Food and Drug Administration warned healthcare professionals and their patients on December 18, 2006 about a deadly side effect of using the immune system suppressing drug Rituxan to treat a condition called systemic lupus erythematosus, or SLE.  A recent report alerted the FDA to two deaths from a brain infection called progressive multifocal leukoencephalopathy (PML) that resulted from off-label use of Rituxan to treat SLE, for which there is no treatment and is usually fatal.

Since 1997, doctors have used Rituxan to treat the autoimmune diseases rheumatoid arthritis and non-Hodgkin's lymphoma.  Rituxan suppresses the body's ability to produce certain types of white blood cells called B cells for periods between six and nine months.  Unfortunately, a side effect of suppressing the immune system is that it decreases the body's natural disease and infection fighting capabilities, leaving the patient open to a host of serious complications such as PML.  In fact, Rituxan is so potentially dangerous that doctors prescribe it only when other treatments have failed, in order to reduce the likelihood of serious complications.

Some of the warning signs of PML include:
  • Dizziness
  • Mental confusion
  • Difficulty speaking
  • Difficulty walking
  • Loss of balance
  • Vision Difficulties

PML is an extremely dangerous and usually fatal disease that affects the central nervous system and the brain.  Part of the dangers of prescribing Rituxan for conditions such as SLE is that it is difficult to distinguish the early signs of PML from the aspects of SLE it is trying to treat.  There  have been at least 23 confirmed cases of Rituxan-linked PML, and in February 2006 the label for Rituxan was changed to reflect the heightened chances of severe viral infections.

If you or someone you know was prescribed Rituxan for an off label use and developed PML or other serious disease as a consequence, you need to take immediate action.  Depending on your circumstances, you could be entitled to pursue a legal case against those responsible, but if you hesitate the statute of limitations in your state could end your case before it has a chance to begin.  Do not let the chance for financial compensation for your pain and suffering slip through your fingers.  Contact our dedicated and experienced defective drug attorneys today.

The law firm of Steigerwalt & Associates is here to help victims of defective drugs throughout the country.
 
 
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