Avastin Associated With Risk of Serious Arterial Thromboembolic Events

Yael Waknine

Disclosures

August 13, 2004

Aug. 13, 2004 — The U.S. Food and Drug Administration (FDA) and Genentech, Inc., sent a letter yesterday to healthcare professionals that warns of the risk for serious and fatal arterial thromboembolic events related to the use of bevacizumab (Avastin) in patients with metastatic colorectal cancer.

The warning was based on results from randomized, active-controlled studies showing that patients with colorectal cancer receiving bevacizumab in addition to 5-fluorouracil infusional therapy had a twofold higher risk of serious arterial thromboembolic events, with an estimated overall risk of 5%.

Risk factors causing higher rates of arterial thrombosis include a history of arterial thromboembolism prior to bevacizumab therapy, age 65 years and older, and bevacizumab exposure.

The FDA recommends that bevacizumab be permanently discontinued in patients who experience an arterial thromboembolic event, including cerebrovascular accident (stroke), myocardial infarction, transient ischemic attack, and angina.

Information regarding the use of bevacizumab may be obtained by calling Genentech's Medical Information/Communications Department at 1-800-821-8590.

Healthcare professionals should report any serious adverse events suspected to be associated with the use of bevacizumab to Genentech at 1-888-835-2555. Information may also be reported to MedWatch, the FDA's safety information and adverse event reporting program, by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mailing the MedWatch form FDA 3500 to the FDA Medical Products Reporting Program, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at https://www.accessdata.fda.gov/scripts/medwatch/.

Reviewed by Gary D. Vogin, MD

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