Severe mucocutaneous reactions, some with fatal outcome, have been reported

Rituxan® and MabThera® (generic name: Rituximab) are antibodies used to treat rheumatoid arthritis, B cell non-Hodgkin’s lymphoma, B cell leukemia, and some autoimmune disorders. The widely-prescribed drug was developed by IDEC Pharmaceuticals and approved by the FDA in 1997.

In December of 2006, the manufacturer of Rituxan issued an official warning letter, advising healthcare professionals that Rituxan has been linked to deaths of lupus patients. These deaths occurred from the rare brain disease, Progressive multifocal leukoencephalopathy (PML). This drastic warning came barely a month after the manufacturer had also issued an official warning, noting that Rituxan can cause bowel obstruction and gastrointestinal perforation. In some cases reported, Rituxan patients with bowel obstruction and perforation have died from their injuries.

As of May, 2007, the official Rituxan website carries the following warnings on the home page:

Fatal Infusion Reactions: Deaths within 24 hours of RITUXAN infusion have been reported. These fatal reactions followed an infusion reaction complex, which included hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Approximately 80% of fatal infusion reactions occurred in association with the first infusion.

Tumor Lysis Syndrome (TLS): Acute renal failure requiring dialysis with instances of fatal outcome has been reported in the setting of TLS following treatment of non-Hodgkin’s lymphoma (NHL) patients with RITUXAN.

Severe Mucocutaneous Reactions: Severe mucocutaneous reactions, some with fatal outcome, have been reported in association with RITUXAN treatment.

Progressive Multifocal Leukoencephalopathy (PML): JC virus infection resulting in PML and death has been reported in patients treated with Rituxan.

The manufacturer of Rituxan warns patients to notify their doctor prior to use if they have any of the following conditions:

  • Heart problems (angina, arrhythmias, etc.)
  • Lung problems
  • Hepatitis B virus
  • High number of cancerous cells
  • Kidney problems

Some of the most common side-effects noted with Rituxan use are:

  • Abnormal, black, bloody, tarry stools
  • Bleeding gums
  • Bloating/swelling of arms, hands, face, lower legs
  • Blurred vision
  • Persistent cough/hoarseness
  • Increased thirst/hunger/urination
  • Painful urination or difficulty urinating
  • Stuffy/runny nose
  • Nervousness
  • Nausea, vomiting
  • Unusual weight gain or loss
  • Vomiting

For a full list, please see the manufacturer’s website at

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