Content, Consistency, and Quality of Black Box Warnings: Time for a Change
Authors: Tarig Elraiyah, Michael R. Gionfriddo, Victor M. Montori, Mohammad Hassan Murad
Journal: Annals of Internal Medicine (2015)

Ideas and Opinions1 December 2015Content, Consistency, and Quality of Black Box Warnings: Time for a ChangeTarig Elraiyah, MBBS, MSc, Michael R. Gionfriddo, PharmD, Victor M. Montori, MD, MSc, and Mohammad Hassan Murad, MD, MPHTarig Elraiyah, MBBS, MScFrom Mayo Clinic, Rochester, Minnesota.Search for more papers by this author, Michael R. Gionfriddo, PharmDFrom Mayo Clinic, Rochester, Minnesota.Search for more papers by this author, Victor M. Montori, MD, MScFrom Mayo Clinic, Rochester, Minnesota.Search for more papers by this author, and Mohammad Hassan Murad, MD, MPHFrom Mayo Clinic, Rochester, Minnesota.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M15-1097 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail A black box warning (BBW) is the highest level of warning issued by the U.S. Food and Drug Administration (FDA). It aims to inform the patient and the prescriber of the potential major risks or life-threatening adverse reactions associated with the use of a medication. The warning is usually placed on top of the drug information label and is highlighted with a black box that distinguishes it from the rest of the text. These warnings are required when there is reasonable evidence of association between the drug and a significant safety concern suggested by either human or animal studies (1).... References1. Murphy S, Roberts R. “Black box” 101: how the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk. J Allergy Clin Immunol. 2006;117:34-9. [PMID: 16387581] CrossrefMedlineGoogle Scholar2. Karpel JP, Peters JI, Szema AM, Smith B, Anderson PJ. Differences in physicians' self-reported knowledge of, attitudes toward, and responses to the black box warning on long-acting beta-agonists. Ann Allergy Asthma Immunol. 2009;103:304-10. 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[PMID: 25766055] doi:10.1016/j.jclinepi.2015.01.025 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From Mayo Clinic, Rochester, Minnesota.Disclaimer: The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health.Grant Support: Dr. Gionfriddo was supported by Clinical and Translational Science Award grant number TL1 TR000137 from the National Center for Advancing Translational Sciences.Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-1097.Corresponding Author: Mohammad Hassan Murad, MD, MPH, Knowledge and Evaluation Research Unit, Mayo Clinic, 200 First Street SW, Rochester, MN 55905; e-mail, Murad.[email protected]edu.Current Author Addresses: Dr. Elraiyah: Mayo Clinic, 200 First Street SW, Rochester, MN 55905.Dr. Gionfriddo: Mayo Clinic, Plummer 3—CTSA, 200 First Street SW, Rochester, MN 55905.Dr. Montori: Knowledge and Evaluation Research Unit, Mayo Clinic, Plummer 4-402, 200 First Street SW, Rochester, MN 55905.Dr. Murad: Knowledge and Evaluation Research Unit, Mayo Clinic, 200 First Street SW, Rochester, MN 55905.Author Contributions: Conception and design: T. Elraiyah, M.R. Gionfriddo, M.H. Murad.Analysis and interpretation of the data: T. Elraiyah, M.R. Gionfriddo, V.M. Montori, M.H. Murad.Drafting of the article: T. Elraiyah, M.R. Gionfriddo, M.H. Murad.Critical revision of the article for important intellectual content: M.R. Gionfriddo, V.M. Montori, M.H. Murad.Final approval of the article: T. Elraiyah, M.R. Gionfriddo, V.M. Montori, M.H. Murad.Administrative, technical, or logistic support: M.H. Murad.Collection and assembly of data: T. Elraiyah, M.R. Gionfriddo.This article was published online first at www.annals.org on 29 September 2015. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoContent, Consistency, and Quality of Black Box Warnings Christine M. Cheng and Colleen DeLizza Content, Consistency, and Quality of Black Box Warnings Tarig Elraiyah and Mohammad Hassan Murad Metrics Cited byImproving attribution of adverse events in oncology clinical trialsRisk Evaluation and Mitigation Strategies (REMSs): Are They Improving Drug Safety? A Critical Review of REMSs Requiring Elements to Assure Safe Use (ETASU)Osteoporosis Therapy: Bone Modeling during Growth and AgingContent, Consistency, and Quality of Black Box WarningsChristine M. Cheng, PharmD and Colleen DeLizza, BS Pharm 1 December 2015Volume 163, Issue 11Page: 875-876KeywordsClinical decision support systemsDrugsEvidence based medicineFood and Drug AdministrationGrading of Recommendations Assessment Development and EvaluationRisk assessmentsSafetySafety studiesScientistsSuicide ePublished: 29 September 2015 Issue Published: 1 December 2015 Copyright & PermissionsCopyright © 2015 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...