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July 5, 2006

Recombinant Factor VIIa and Thromboembolic Events

Author Affiliations

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2006;296(1):43-44. doi:10.1001/jama.296.1.43-b

To the Editor: Dr O’Connell and colleagues1 reviewed thromboembolic complications of recombinant human coagulation factor VIIa (rFVIIa) as reported to the US Food and Drug Administration (FDA) MEDWATCH database. As with any medication, rFVIIa has both positive and negative effects; therefore, risks and benefits must be considered before administering the drug. In our trauma practice, we cannot know which of our patients with life-threatening hemorrhage are also at risk for ischemic stroke, myocardial infarction, or other thrombotic complications. We are cautious with rFVIIa use in the presence of arterial injury and will not use it in patients undergoing extracorporeal circulatory support. However, some patients have dilutional coagulopathy severe enough to warrant the use of almost any therapy to salvage them from hemorrhagic shock, regardless of risk.2 A recent randomized, placebo-controlled, double-blind trial of the use of rFVIIa in patients with trauma did not find an increased risk of thromboembolic events.3 This study, however, excluded patients older than 65 years, who would be most likely to experience adverse thromboembolic events.

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