Content, Consistency, and Quality of Black Box Warnings
Authors: Christine M. Cheng, Colleen DeLizza
Journal: Annals of Internal Medicine (2016)

Letters5 July 2016Content, Consistency, and Quality of Black Box WarningsChristine M. Cheng, PharmD and Colleen DeLizza, BS PharmChristine M. Cheng, PharmDFrom First Databank, San Francisco, California.Search for more papers by this author and Colleen DeLizza, BS PharmFrom First Databank, San Francisco, California.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/L16-0072 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:Elraiyah and colleagues (1) propose that adding an evidence profile would improve the usefulness of black box warnings (BBWs). Although knowing the quality of evidence supporting each warning may help prescribers gauge the strength of association between a drug and an adverse reaction, we suggest that assessing the patient's risk factors for the reaction is critical to determine the warning's applicability to an individual patient. As the authors reported, all of the BBWs that they evaluated describe the at-risk population.We have reviewed BBWs for more than 3000 prescription drugs and have noted that the content, level ...References1. Elraiyah T, Gionfriddo MR, Montori VM, Murad MH. Content, consistency, and quality of black box warnings: time for a change. Ann Intern Med. 2015;163:875-6. [PMID: 26415046]. doi:10.7326/M15-1097 LinkGoogle Scholar2. Sousa-Pinto B, Pinto-Ramos J, Correia C, Gonçalves-Costa G, Gomes L, Gil-Mata S, et al. Pharmacogenetics of abacavir hypersensitivity: a systematic review and meta-analysis of the association with HLA-B*57:01 [Letter]. J Allergy Clin Immunol. 2015;136:1092-4. [PMID: 25934581] doi:10.1016/j.jaci.2015.03.019 CrossrefMedlineGoogle Scholar3. U.S. Food and Drug Administration. Guidance for Industry: Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products—Content and Format. Silver Spring, MD: U.S. Food and Drug Administration; 2011. Accessed at www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075096 on 8 October 2015. Google Scholar Author, Article, and Disclosure InformationAffiliations: From First Databank, San Francisco, California.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=L16-0072. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoContent, Consistency, and Quality of Black Box Warnings: Time for a Change Tarig Elraiyah , Michael R. Gionfriddo , Victor M. Montori , and Mohammad Hassan Murad Content, Consistency, and Quality of Black Box Warnings Tarig Elraiyah and Mohammad Hassan Murad Metrics 5 July 2016Volume 165, Issue 1Page: 74KeywordsAdverse reactionsDisclosureDrugsHealth information technologyMedical risk factorsProgressive multifocal leukoencephalopathyProspective studiesResearch designRisk assessmentsTherapeutic drug monitoring ePublished: 5 July 2016 Issue Published: 5 July 2016 Copyright & PermissionsCopyright © 2016 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...