The FDA and Genentech, Inc., have issued an important warning to health care providers about bevacizumab (Avastin™) in relation to an increased risk of cerebrovascular accidents, myocardial infarctions, transient ischemic attacks, and angina. The risk of fatal arterial thrombotic events is also increased.

In studies of patients with metastatic colorectal cancer, the risk of a serious arterial thrombotic event was approximately two-fold higher in patients receiving infusional 5-fluorouracil-based chemotherapy plus the bevacizumab.

A revised package insert with more details on arterial thromboembolic events is under development.

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