The labeling now states that the condition, reversible posterior leukoencephalopathy syndrome (RPLS), could be a potential side-effect after taking Avastin. The rare brain disorder is bleeding syndrome that can result in seizures and headaches.
Seven reports of patients who developed holes inside the nose called septum perforations have also been included on the label said the FDA.
However studies of Avastin have shown that less than 0.1% of patients developed symptoms of the disorder and Genentech is said to be reviewing data on RPLS. Avastin is used in combination with chemotherapy to treat metastatic colorectal cancer.
Roche Holding AG is the majority owner of Genentech and markets Avastin outside the US. Avastin generated sales of around $1.1 billion for in 2005.