Veronica Yank, MD; Aaron C. Logan, MD, PhD; Randall S. Stafford, MD, PhD
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M10-2334.
Yank V., Logan A., Stafford R.; Off-Label Use of Recombinant Factor VIIa. Ann Intern Med. 2011;155:338-339. doi: 10.7326/0003-4819-155-5-201109060-00022
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Published: Ann Intern Med. 2011;155(5):338-339.
We appreciate the comments on our 2 analyses of off-label use of rFVIIa. Our investigation of U.S. hospital data indicated that between 2000 and 2008, off-label use of this biologic increased more than 140-fold (1). In 2008, off-label uses in such settings as cardiovascular surgery, intracranial hemorrhage, and trauma accounted for 97% of in-hospital use. Our second study, a systematic review of 5 inpatient, off-label uses of rFVIIa, analyzed the results of 17 randomized clinical trials, 26 comparative observational studies, and 19 noncomparative observational studies (2). These studies showed no mortality reduction with rFVIIa use and, for some indications, an increase in thromboembolism.
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