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July 5, 2006

Recombinant Factor VIIa and Thromboembolic Events—Reply

Author Affiliations

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

JAMA. 2006;296(1):43-44. doi:10.1001/jama.296.1.44-a

In Reply: The comments from Dr Dutton and colleagues emphasize the importance of benefit-risk considerations for patients in extremis vs those who are not. Available information from the FDA's database of 168 patients with post-rFVIIa thromboembolic events does not include sufficient detail to respond to all of their questions. However, regarding prophylactic use, the records identify only 1 patient who underwent warfarin reversal. An elderly man with an international normalized ratio of 2.7 received fresh-frozen plasma (6 units) and 2.4 mg of rFVIIa (30 μg/kg) before evacuation of a subdural hematoma, and vitamin K after surgery. Pulmonary embolism was diagnosed 3 days later. Among 46 reports of prophylactic rFVIIa use, 26 specifically mentioned the presence of serious liver disease.

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