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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.

We agree about the importance of reporting serious adverse events to the FDA's MedWatch program and including as complete detail as possible. These anecdotal reports can contribute to the design of . . . [Full Text of this Article]

Kathryn A. O’Connell, MD, PhD
kathryn.oconnell@hhs.fda.gov

Robert P. Wise, MD, MPH
Division of Epidemiology

Jay N. Lozier, MD, PhD
Division of Hematology
Office of Blood Research and Review

M. Miles Braun, MD, MPH
Division of Epidemiology
Center for Biologics Evaluation and Research
Food and Drug Administration
Rockville, Md

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