Off-Label Use of Recombinant Factor VIIa
Authors: Veronica Yank, Aaron C. Logan, Randall S. Stafford
Journal: Annals of Internal Medicine (2011)

Letters6 September 2011Off-Label Use of Recombinant Factor VIIaVeronica Yank, MD, Aaron C. Logan, MD, PhD, and Randall S. Stafford, MD, PhDVeronica Yank, MDFrom Stanford University, Stanford, CA 94304-5411; Stanford University School of Medicine, Stanford, CA 94305; and Stanford University, Stanford, CA 94304-5411.Search for more papers by this author, Aaron C. Logan, MD, PhDFrom Stanford University, Stanford, CA 94304-5411; Stanford University School of Medicine, Stanford, CA 94305; and Stanford University, Stanford, CA 94304-5411.Search for more papers by this author, and Randall S. Stafford, MD, PhDFrom Stanford University, Stanford, CA 94304-5411; Stanford University School of Medicine, Stanford, CA 94305; and Stanford University, Stanford, CA 94304-5411.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-155-5-201109060-00022 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE: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 ...References1. Logan AC, Yank V, Stafford RS. Off-label use of recombinant factor VIIa in U.S. hospitals: analysis of hospital records. Ann Intern Med. 2011;154:516-22. [PMID: 21502649] LinkGoogle Scholar2. Yank V, Tuohy CV, Logan AC, Bravata DM, Staudenmayer K, Eisenhut R, et al. Systematic review: benefits and harms of in-hospital use of recombinant factor VIIa for off-label indications. Ann Intern Med. 2011;154:529-40. [PMID: 21502651] LinkGoogle Scholar3. Fugh-Berman A, Melnick D. Off-label promotion, on-target sales. PLoS Med. 2008;5:210. [PMID: 18959472] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From Stanford University, Stanford, CA 94304-5411; Stanford University School of Medicine, Stanford, CA 94305; and Stanford University, Stanford, CA 94304-5411.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M10-2334. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoOff-Label Use of Recombinant Factor VIIa in U.S. Hospitals: Analysis of Hospital Records Aaron C. Logan , Veronica Yank , and Randall S. Stafford Off-Label Use of Recombinant Factor VIIa Anne Phillips Off-Label Use of Recombinant Factor VIIa Awori J. Hayanga Metrics 6 September 2011Volume 155, Issue 5Page: 338-339KeywordsHemorrhageObservational studiesOutpatient clinicsRed blood cellsSurgerySurvival analysisSystematic reviewsThromboembolismTrauma surgery ePublished: 6 September 2011 Issue Published: 6 September 2011 Copyright & PermissionsCopyright © 2011 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...