Off-Label Use of Recombinant Factor VIIa
Authors: Awori J. Hayanga
Journal: Annals of Internal Medicine (2011)

Letters6 September 2011Off-Label Use of Recombinant Factor VIIaAwori J. Hayanga, MPHAwori J. Hayanga, MPHFrom University of Washington, Seattle, WA 98121.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-155-5-201109060-00021 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:The article by Logan and colleagues (1) provides appropriate insight into prevailing patterns of use of rFVIIa. The authors specifically report that cardiac surgery constitutes the largest single off-label use of rFVIIa and hint at possible overuse. Any indictment of such use, however, is best tempered by knowing that most cardiac interventions today are indeed off-label. This is particularly true of percutaneous interventions (2).The U.S. Food and Drug Administration's approval in isolation, therefore, does not govern all contemporary practice decision making in cardiovascular health care delivery in the United States. This has been well-demonstrated in the ...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. Holmes DR, Bell MR, Holmes DR, Berger PB, Bresnahan JF, Hammes LN, et al. Interventional cardiology and intracoronary stents—a changing practice: approved vs. nonapproved indications. Cathet Cardiovasc Diagn. 1997;40:133-8. [PMID: 9047049] CrossrefMedlineGoogle Scholar3. Roy P, Buch AN, Javaid A, Okabe T, Raya V, Pinto Slottow TL, et al. Impact of “off-label” utilization of drug-eluting stents on clinical outcomes in patients undergoing percutaneous coronary intervention. Am J Cardiol. 2008;101:293-9. [PMID: 18237587] CrossrefMedlineGoogle Scholar4. Diprose P, Herbertson MJ, O'Shaughnessy D, Gill RS. Activated recombinant factor VII after cardiopulmonary bypass reduces allogeneic transfusion in complex non-coronary cardiac surgery: randomized double-blind placebo-controlled pilot study. Br J Anaesth. 2005;95:596-602. [PMID: 16183679] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Awori J. Hayanga, MPHAffiliations: From University of Washington, Seattle, WA 98121.Disclosures: None disclosed. 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 Veronica Yank , Aaron C. Logan , and Randall S. Stafford Off-Label Use of Recombinant Factor VIIa Anne Phillips Metrics Cited byEthics & Evidence in Medical Debates: The Case of Recombinant Activated Factor VII 6 September 2011Volume 155, Issue 5Page: 337-338KeywordsBlood transfusionCardiac surgeryDrugsElderlyFood and Drug AdministrationHealth careHemorrhageHemostasisHemostaticsStent implantation ePublished: 6 September 2011 Issue Published: 6 September 2011 Copyright & PermissionsCopyright © 2011 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...