Rituxan Safety Alert Follows Death of Two Lupus Patients

Two lupus patients have died after being treated with Rituxan (rituximab). The FDA has issued a safety alert regarding Rituxan treatment and is working with Genentech to inform healthcare professionals about emerging information. The cause of death for the two lupus patients was a viral infection of the brain, known as PML or progressive multifocal leukoencephalopathy. PML is caused by reactivated JC virus. Latent JC virus is present in about 80 percent of adults.

According to the FDA, Rituxan is a powerful immunosuppressant that eliminates mature circulating B-cells for up to nine months. Rituxan is FDA-approved for the treatment of CD20-positive, B-cell, non-Hodgkins lymphoma and for patients with moderate to severe rheumatoid arthritis who have had an inadequate response to other treatment options. Rituxan has been used off-label for other serious conditions including lupus. It has been estimated that about 10,000 patients with systemic lupus erythematosus have been treated with Rituxan.

The FDA warns that reactivation and exacerbation of viral infections including JC virus leading to PML may occur in patients treated with Rituxan for any indication. The FDA and Genentech are gathering more information and working to strengthen warnings about the risk of PML in Rituxan labeling. Physicians have been warned to maintain a "high index of suspicion" for the development of PML in patients receiving Rituxan treatment. Patients who have been treated with Rituxan and develop neurological signs or symptoms should be evaluated for PML.

• FDA Public Health Advisory (includes symptoms of PML)
• Healthcare Professional Sheet (FDA)
• Progressive Multifocal Leukoencephalopathy Information (NINDS)

More Related Resources:

• The Facts of Rituxan
• Subsequent Rituxan Treatment Yields Better Outcomes
• Are Some Arthritis Patients Unsuitable Candidates for Biologic Drugs?

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