A Hemorrhage of Off-Label Use
Authors: Jerry Avorn, Aaron S. Kesselheim
Journal: Annals of Internal Medicine (2011)

Letters6 September 2011A Hemorrhage of Off-Label UseJerry Avorn, MD and Aaron S. Kesselheim, MD, JD, MPHJerry Avorn, MDFrom Harvard Medical School, Brigham and Women's Hospital, Boston, MA 02120.Search for more papers by this author and Aaron S. Kesselheim, MD, JD, MPHFrom Harvard Medical School, Brigham and Women's Hospital, Boston, MA 02120.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-155-5-201109060-00024 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE:We sympathize with the plight of physicians trying to emergently manage a patient with refractory, life-threatening bleeding, as described by Drs. Karkouti and Levy. However, Yank and colleagues (1) show that rFVIIa confers little or no benefit and is associated with a significantly elevated risk for thrombotic events, and most patients studied were given this product under just such emergent conditions. The same results were found in another recent comprehensive review of the literature, on which Dr. Levy was a coauthor (2), and this conclusion was highlighted in an accompanying editorial (3). The cited randomized trial by Gill ...References1. 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 Scholar2. 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 Scholar3. Aledort LM. Off-label use of recombinant activated factor VII—safe or not safe? [Editorial]. N Engl J Med. 2010;363:1853-4. [PMID: 21047230] 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. Elstein AS. Heuristics and biases: selected errors in clinical reasoning. Acad Med. 1999;74:791-4. [PMID: 10429587] CrossrefMedlineGoogle Scholar6. Berg A, Morton S, eds. Finding What Works in Health Care: Standards for Systematic Reviews. Washington, DC: National Academic Pr; 2011. Google Scholar Author, Article, and Disclosure InformationAuthors: Jerry Avorn, MD; Aaron S. Kesselheim, MD, JD, MPHAffiliations: From Harvard Medical School, Brigham and Women's Hospital, Boston, MA 02120.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-0550. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoSystematic Review: Benefits and Harms of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications Veronica Yank , C. Vaughan Tuohy , Aaron C. Logan , Dena M. Bravata , Kristan Staudenmayer , Robin Eisenhut , Vandana Sundaram , Donal McMahon , Ingram Olkin , Kathryn M. McDonald , Douglas K. Owens , and Randall S. Stafford A Hemorrhage of Off-Label Use Jerry Avorn and Aaron Kesselheim A Hemorrhage of Off-Label Use Keyvan Karkouti and Jerrold H. Levy Metrics 6 September 2011Volume 155, Issue 5Page: 339-340KeywordsConflicts of interestDecision makingDisclosureHemorrhageInfarctionMyocardial infarctionPatientsRandomized trialsStrokeSystematic reviews ePublished: 6 September 2011 Issue Published: 6 September 2011 Copyright & PermissionsCopyright © 2011 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...