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-Sept. 12, 2008
On Sept. 11, the FDA reported a fatal case of the brain infection known as PML in a woman who had taken Rituxan, the arthritis and non-Hodgkin's lymphoma cancer drug co-marketed by Genentech and Biogen Idec. Other cases of PML had been linked to Rituxan in non-approved uses, but in the latest case, the patient was taking Rituxan for an approved use — arthritis.
Progressive Multifocal Leukoencephalopathy
PML, or progressive multifocal leukoencephalopathy, is a life-threatening disease of the brain’s white matter. The symptoms of PML include:
The FDA’s report on the latest case of PML linked to Rituxan noted that the patient had undergone radiation and chemotherapy for cancer before she developed the PML.
Biogen Idec and Genentech Respond
The various reports of PML in patients who have taken PML have resulted in a reduction of the stock value of Biogen Idec. As for Genentech, a company spokeswoman noted that the labeling for Rituxan already mentions the risk of PML. She stated, "The patient had a number of confounding factors that make it difficult to assess the potential role, if any, that Rituxan exposure may have played."
(Source: Associated Press)
If you have taken Rituxan and are concerned about PML, contact an attorney in your area today.