FDA Video: Rituxan Linked to PML (Progressive Multifocal Leukoencephalopathy) Brain Infections

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Below is an excellent video produced by the U.S. Food & Drug Administration (FDA), which warns patients and physicians of serious, life-threatening viral brain infections (Progressive Multifocal Leukoencephalopathy) linked to Rituxan (Rituximab).

FDA is alerting health care professionals and patients about new reports of a serious viral infection in patients with systemic lupus erythematosus who were treated with Rituxan (rituximab). Rituxan is an immunosuppressant drug that is approved to treat certain patients with rheumatoid arthritis and non-Hodgkin’s lymphoma. It is not approved to treat lupus.

The FDA advisory says that two patients with lupus died after being treated with Rituxan. These patients developed a life-threatening viral infection of the brain called progressive multifocal leuko-encephalopathy (PML). PML is caused by reactivation of the JC virus. There are no known treatments for PML and it is usually fatal. PML has also occurred in patients with lymphoid malignancies who have been treated with Rituxan.

FDA is working with Genentech, the manufacturer of Rituxan, to get more information about the occurrence of PML in patients treated with the drug and to strengthen the warnings for this product. Here is what FDA’s advisory recommends:

  • Physicians who are thinking about treating a patient with Rituxan for any condition should tell their patients about the chance of PML because there is no effective treatment for the disease.
  • Healthcare professionals should be on the alert for the development of PML in patients being treated with the drug.
  • Patients on Rituxan should contact their physicians if they experience any new neurological signs or symptoms such as confusion, dizziness, loss of balance, difficulty talking or walking and vision problems. These could be warning signs of PML, but they could also be associated with the underlying disease for which the drug was prescribed.
  • Finally, healthcare providers and patients should report suspected PML or other serious adverse events following Rituxan therapy through FDA’s MedWatch program.
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