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Avastin

Avastin cancer drug may cause brain bleeding, warns FDA

Wednesday, September 27, 2006 by: Jerome Douglas
Tags: Avastin, Genentech, drug side effects


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(NewsTarget) Genentech's cancer-fighting drug Avastin's label now includes warnings related to a rare brain-bleeding condition and deterioration of nasal tissue that both have been associated with the drug. The FDA's website now notes that Avastin can possibly cause a rare brain-capillary leak syndrome that can lead to headaches, seizure, blindness and other visual and neurological problems.

Genentech countered with its own statistics, saying that less than 0.1 percent of the 60,000 patients treated with Avastin have reported these related conditions, and in addition, that the conditions are reversible. The side effect includes small holes that develop between the cartilage separating the two nostrils that result in nasal discharge and bleeding.

Genentech was not actively pursuing possible visual and neurological problems related to its Avastin drug until some letters to the New England Journal of Medicine were published in the March 2006 issue. In addition, the Food and Drug Administration wants more information before it decides whether to approve Avastin as a cancer-treatment drug, which will probably delay final FDA action until late 2007.

Genentech has indicated to stockholders that FDA approval for new uses of Avastin would help boost the drug's profit margin by about two-thirds -- as much as $90,000 per patient annually -- due to the fact that some uses of the drug, like breast cancer treatment, require twice as much product to be used compared to colorectal cancer treatments.

Genentech's Avastin generated $1.1 billion in revenue in 2005 and is currently used with traditional chemotherapy treatments to treat colorectal cancer. In addition to the previously noted side effects, Genentech says that other side effects of Avastin include nosebleeds, high blood pressure, too much protein in the urine, weakness, pain, diarrhea and reduced white blood-cell count.

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