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FDA Public Health Advisory
Life-threatening Brain Infection in Patients with Systemic Lupus Erythematosus
After Rituxan (Rituximab) Treatment
FDA has received reports of the death of two patients who were treated with Rituxan for systemic lupus erythematosus (SLE). Both patients developed a life-threatening viral infection of the brain. This infection is called progressive multifocal leukoencephalopathy (PML). PML is caused by the JC virus and is usually fatal. There are no known effective treatments for PML.
The signs of PML include confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems. Recognition of these warning signs of PML may be obscured by the fact that they are also associated with the underlying diseases for which Rituxan may be prescribed.
- Patients who have been treated with Rituxan should contact their doctor if they experience any warning signs like those listed above--to find out the exact cause of their warning signs and to be checked for PML.
- Physicians who are thinking about treating a patient with Rituxan for any condition should inform their patient about the chance of PML with Rituxan treatment because there is no known effective treatment for PML.
- Patients who are taking or are considering taking Rituxan should be aware of the chance of developing PML and discuss it with their doctor.
Rituxan is a powerful medication that is 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 six to nine months. Rituxan 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 for the treatment of SLE. The sponsor estimates that approximately 10,000 patients with SLE have been treated with Rituxan.
In February 2006, the labeling for Rituxan was updated 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 Rituxan. FDA is working to gather more information about Rituxan and PML and to strengthen the Warnings about PML in the Rituxan product label.
More details about Rituxan and PML can be found in FDA’s Information for Healthcare Professionals at http://www.fda.gov/cder/drug/InfoSheets/HCP/rituximab.pdf 
The FDA asks health care professionals and patients to report possible cases of PML to the FDA through the MedWatch program by phone (1-800-FDA-1088) or by the Internet at http://www.fda.gov/medwatch.
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Date created: December 18, 2006 |
