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Biogen sued over drug safety

Thu, 08/12/2010 - 1:32pm
Mass High Tech: The Journal of New England Technology

A Nebraska man has filed suit in federal court against Biogen Idec Inc. and its West Coast partner, alleging that the company did not properly advise patients of the risks associated with its drug, Rituxan.

Cambridge-based Biogen and San Francisco-based Genentech Inc. are the defendants in the suit, brought by 23-year-old Jesse Peetz, who said he suffered an infection that left him paralyzed and said that Rituxan was to blame for making him more susceptible to such infections.

The two biotechnology companies did issue warnings in 2007, but Peetz, who started taking the drug in 2003, says the warning should have been issued sooner.

Biogen declined to comment specifically on the case, but spokeswoman Christina Chan said, “It’s important to note that the drug has been used extensively in 2 million patients worldwide. We are committed to ethical practices and we are confident in, and proud of, our stringent standards in this regard.”

Rituxan is approved for the treatment of non-Hodgkins lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis. Peetz was taking the medication for thrombotic thrombocytopenic purpura, a rare blood disease that can result in kidney failure or stroke. The drug is not approved for that indication.

In December 2006, the FDA issued an alert noting that two patients taking Rituxan diead from an infection of the central nervous system known as multifocal leukoencephalopathy (PML). The patients were taking the drug to treat systemic lupus erythematosus, which is not an approved use of the drug.

 

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