Warnings, COLUMNS-Drugs & Supplements, August 2004

FDA, Genentech Warn Of Stroke, Heart Attack Risk For Avastinâ„¢ Patients

WASHINGTON, D.C. - The U.S. Food and Drug Administration said in an Aug. 12 alert that Genentech Inc. has sent warnings to oncologists and other healthcare providers that there is evidence of increased risk of stroke and heart attack for patients taking Avastinâ„¢ as part of a regimen for treatment of colorectal cancer.

The one-page letter from Genentech's Chief Medical Officer, Hal Barron M.D., FACC, said, "Specifically, there is evidence of an increased risk of serious arterial thromboembolic events including cerebrovascular accidents (stroke), myocardial infarctions, transient ischemic attacks, and …