A Hemorrhage of Off-Label Use
Authors: Keyvan Karkouti, Jerrold H. Levy
Journal: Annals of Internal Medicine (2011)

Letters6 September 2011A Hemorrhage of Off-Label UseKeyvan Karkouti, MD and Jerrold H. Levy, MDKeyvan Karkouti, MDFrom Toronto General Hospital, University of Toronto, Toronto, Ontario M5G 2C4, Canada, and Emory University School of Medicine, Atlanta, GA 30322.Search for more papers by this author and Jerrold H. Levy, MDFrom Toronto General Hospital, University of Toronto, Toronto, Ontario M5G 2C4, Canada, and Emory University School of Medicine, Atlanta, GA 30322.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-155-5-201109060-00023 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:The editorial comment by Avorn and Kesselheim (1) on recent systematic reviews of off-label use of rFVIIa raises concern about the “rapidly increasing use of a treatment that does not benefit patients and increases the risk for dangerous thrombotic events”—and “costs $10 000 per dose.” This concern, however, fails to consider the clinical context in which clinicians choose to administer rFVIIa, which is during refractory blood loss.When presented with a patient who continues to bleed despite administration of all available therapies, clinicians have 2 choices: Keep administering the standard interventions that have failed to work in that ...References1. Avorn J, Kesselheim A. A hemorrhage of off-label use [Editorial]. Ann Intern Med. 2011;154:566-7. [PMID: 21502655] LinkGoogle Scholar2. 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 Scholar3. Karkouti K, Beattie WS, Arellano R, Aye T, Bussieres JS, Callum JL, et al. Comprehensive Canadian review of the off-label use of recombinant activated factor VII in cardiac surgery. Circulation. 2008;118:331-8. [PMID: 18606914] CrossrefMedlineGoogle Scholar4. Gill R, Herbertson M, Vuylsteke A, Olsen PS, von Heymann C, Mythen M, et al. Safety and efficacy of recombinant activated factor VII: a randomized placebo-controlled trial in the setting of bleeding after cardiac surgery. Circulation. 2009;120:21-7. [PMID: 19546387] CrossrefMedlineGoogle Scholar5. Levi M, Levy JH, Andersen HF, Truloff D. Safety of recombinant activated factor VII in randomized clinical trials. N Engl J Med. 2010;363:1791-800. [PMID: 21047223] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From Toronto General Hospital, University of Toronto, Toronto, Ontario M5G 2C4, Canada, and Emory University School of Medicine, Atlanta, GA 30322.Disclosures: The authors have consulted for and have received research funding from Novo Nordisk. 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 A Hemorrhage of Off-Label Use Jerry Avorn and Aaron Kesselheim A Hemorrhage of Off-Label Use Jerry Avorn and Aaron S. Kesselheim Metrics Cited ByEthics & Evidence in Medical Debates: The Case of Recombinant Activated Factor VIIReview of the Off-Label Use of Recombinant Activated Factor VII in Pediatric Cardiac Surgery PatientsNo evidence or no alternative? Taking responsibility for off-label prescribing 6 September 2011Volume 155, Issue 5Page: 339KeywordsBloodConflicts of interestDrugsHemorrhageResearch fundingSafetySafety studiesSystematic reviews ePublished: 6 September 2011 Issue Published: 6 September 2011 CopyrightCopyright © 2011 by American College of Physicians. All Rights Reserved.PDF DownloadLoading ...