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According to the Company, particulate matter, if infused, could lead to potential venous and/or arterial thromboembolism (blockage of blood vessels) and other adverse events including inflammation, particularly in the lungs, and local irritation of blood vessels.
HIT is an acquired, transient, prothrombotic disorder and a life-threatening complication of unfractionated (UFH) and low molecular weight heparin (LMWH) therapy presenting with thrombocytopenia and/or complicating venous or arterial thromboembolism that is associated with increased in vivo thrombin generation [1].
Risk factors for these events include a history of arterial thromboembolism prior to Avastin exposure, an age of 65 years or greater, and Avastin therapy, according to the FDA alert.