Tuesday, December 19, 2006

FDA issues 'misuse' alert of Biogen drug, following two deaths

The U.S. Food and Drug Administration released an alert noting that two patients taking Rituxan -- a drug developed by Cambridge-based Biogen Idec Inc. and Genentech Inc. -- have died from an infection of the central nervous system known as multifocal leukoencephalopathy (PML).

The FDA reports the patients were taking Rituxan to treat systemic lupus erythematosus, which is not an approved use of the drug. The agency has sanctioned the drug only for treating patients with non-Hodgkin's lymphoma and certain cases of rheumatoid arthritis, officials said.

A known side effect of Rituxan is an increased risk of infection, FDA officials said. In addition to the two recent deaths, 23 cases of the deadly PML infections have been reported in patients with lymphoid malignancies either during or after taking Rituxan.

Both South San Francisco-based Genentech and Biogen promote Rituxan as a treatment for non-Hodgkin's lymphoma. Sales of the drug in 2005 reached $1.8 billion, of which Biogen took in $709 million, according to the company.