GENENTECH ADDS ADDITIONAL WARNING TO AVASTIN LABELING

New research showing that Genentech's colorectal cancer drug Avastin may pose an increased risk of arterial thromboembolic events in patients undergoing chemotherapy has prompted the firm to alter the drug's labeling.

"Arterial thromboembolic events occurred at a higher incidence in patients receiving Avastin in combination with chemotherapy as compared to those receiving chemotherapy alone," states the drug's new labeling, which was issued by Genentech in a "Dear Healthcare Provider" letter.

The new language was added to the warnings section of Avastin's (bevacizumab) labeling. Previously, the information about increased arterial thromboembolic risk was included in the label's adverse events section.

Genentech first issued an alert about Avastin's increased thromboembolic risk in a letter to physicians dated Aug. 10, 2004.