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Published on 12 September 2008

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Drug linked to brain disease death

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A patient prescribed the arthritis and cancer drug Rituxan (MabThera) has died after suffering a deadly brain infection, according to regulators.

The US Food and Drug Administration (FDA) said the woman died of the rare viral infection more than 18 months after discontinuing the drug. Genentech and Biogen Idec co-market the drug in the USA.

Cases of the infection had previously been reported in patients taking Rituxan for unapproved uses, including the autoimmune disease lupus. But the FDA said the latest case is the first reported in a patient taking the drug for arthritis. The drug is also approved for non-Hodgkin’s lymphoma.

A spokeswoman for Genentech noted the drug’s label already mentions risks of the infection, adding: “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.”

According to the posting on the FDA’s website, the patient was undergoing chemotherapy and radiation treatment for cancer in the months before she developed the infection.

The drugs watchdog said doctors should immediately stop using Rituxan in patients who develop the infection – progressive multifocal leukoencephalopathy (PML). The agency noted there are no known treatments for PML.

Copyright PA Business 2008

FDA



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