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Avastin (bevacizumab) increased risk of arterial thromboembolic events

January 5, 2005

Patients receiving bevacizumab had twice the risk of serious arterial thrombotic events than patients not receiving bevacizumab during clinical trials. Arterial thromboembolic events occurred in 4.4% of patients given bevacizumab plus chemotherapy, compared with 1.9% of patients given chemotherapy alone. Fatal arterial thrombotic events can occur and may include cerebrovascular accident, myocardial infarctions, transient ischemic attacks, and angina. Risk increases with age, especially in patients over 65 years old. The FDA has issued a MedWatch safety alert and Genentech has updated the product labeling regarding these newly identified risks.  Additional information is available online at the following links:

January 2005 MedWatch Safety Alert –update, provides event rates

• http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150721.htm
• http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM164188.pdf
• http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125085s45lbl.pdf

August 2004 Safety Alert – initial information about these events

• http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166896.htm
• http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM166903.pdf

Updated
January 5, 2005; August 16, 2004; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.