FDA issues alert on Genentech drugDec 18, 2006 | AP
Government Health Officials said they are Seeking Addi
Government health officials said Monday they are seeking additional safety information from Genentech Inc. on Rituxan following reports that two patients died while taking the drug, which is used to treat non-Hodgkins lymphoma and other conditions.
The Food and Drug Administration said it plans to add more warnings to the drug's label on the risk of potentially deadly viral brain side effects. According to FDA, Rituxan reactivated latent JC virus in the two patients who died while taking the drug. Nearly 80 percent of adults have latent JC virus, according to FDA.
Genentech and Biogen Idec Inc., which developed the drug comarketed by Genentech, on Monday sent a letter to physicians and prescribers informing them of two deaths from progressive multifocal leuklencephalopathy, a rare nervous system condition, in patients taking Rituxan. The patients were taking Rituxan for Systemic Lupus Erythematosus, a use for which it is not approved.
In a statement posted on its web site today, the FDA advised physicians to "maintain a high index of suspicion for the development" of the brain virus in patients taking Rituxan.
FDA said it plans to continue gathering more data on the drug and will update its web site with additional advisories.
Genentech reported sales of $1.8 billion for Rituxan last year.