The FDA has issued an alert for Rituxan (Rituximab) after reports of a life-threatening brain infection in patients with systemic lupus erythematosus after treatment with Rituxan.
The 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 called progressive multifocal leukoencephalopathy (PML). PML is usually fatal, and caused by the JC virus. There are no known effective treatments for PML.
The signs of PML include:– confusion
– dizziness or loss of balance
– difficulty talking or walking
– vision problems
Recognizing 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 pharmaceutical drug Rituxan should contact their doctor if they experience any warning signs like those listed above, even if they assume those symptoms to be related to the original illness. It is important that patients taking Rituxan find out the exact cause of their warning signs and that they be checked for PML.
The FDA has advised “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.” If your physician has prescrived Rituxan after the date of this alert, and failed to inform you about the potentialy dealdy risks associated with treatment, you may have grounds for a lawsuit.
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 (Rituximab) is a powerful medication that is used to suppress the immune system. Rituxan 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. The FDA is working to gather more information about Rituxan and PML and to strengthen the Warnings about PML in the Rituxan product label.
Learn more about Rituxan and PML in FDA’s Info Sheet (PDF File opens in new window).
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