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Rituximab (Rituxan®) and Progressive Multifocal Leukoencephalopathy (PML)
October 26, 2009
The FDA and Genentech are warning healthcare providers about a potentially life-threatening brain infection in patients treated with rituximab (Rituxan®). Fatal progressive multifocal leukoencephalopathy (PML) occurred in two patients treated with rituximab up to 1 year earlier for systemic lupus erythematosus. Fatal PML occurred in two patients with rheumatoid arthritis up to 18 months after the patients received their last dose of rituximab. Progressive multifocal leukoencephalopathy has been reported in a third patient with rheumatoid arthritis, occurring within 6 months after rituximab treatment. Unlike both prior cases in patients with rheumatoid arthritis, the third patient had not previously been treated with tumor necrosis factor (TNF) antagonists.
Progressive multifocal leukoencephalopathy is a rare progressive demyelinating disease of the central nervous system. The disorder is caused by reactivation of latent JC virus infection, which is present in up to 80% of adults. Reactivation of viral infections may occur in patients receiving rituximab for any indication.
The FDA and Genentech are revising the product labeling to update warnings about the risk of PML. Monitor patients receiving rituximab for signs of PML, such as major vision changes, unusual eye movements, loss of balance or coordination, disorientation, confusion, or other neurological symptoms. Educate patients to contact their healthcare provider if any of these symptoms occur while on therapy or after stopping therapy.
Additional information can be obtained at the following links:
- FDA MedWatch Alerts:
- 2009:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm187791.htm - 2008:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm094994.htm - 2006:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm150747.htm
- 2009:
- FDA Press Release (2006):
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108810.htm - Dear Healthcare Professional Letters
- Public Health Advisory (2006):
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm124345.htm - Prescribing Information (2008):
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103705s5256lbl.pdf - Healthcare Professional Information Sheet (2006):
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126519.htm - Drug Information Page (2006):
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109106.htm - Questions and Answers on Rituximab:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109107.htm
Updated
October 26, 2009; September 11, 2008; December 21, 2006; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
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