Concepedia

Black Box Warning Analysis

Black Box Warning Analysis is a methodological framework within pharmaceutical safety research that systematically evaluates and interprets the presence, content, and implications of black box warnings—defined as the strongest regulatory warnings by the U.S. Food and Drug Administration—on drug package inserts to assess potential risks, guide clinical decision-making, and inform policy development.

9

Publications

506

Citations

23

Authors

22

Institutions

Publications per year

2017–2026

1

Parents

Publications

9

ADHD Drugs and Cardiovascular Risk

Steven E. Nissen · New England Journal of Medicine · 2006 · 334 citations

, , +15

FDA Requires Black Box Warnings on Labeling for Botulinum Toxin Products

Bridget M. Kuehn · JAMA · 2009 · 46 citations

, , +13

Speaking the same language? International variations in the safety information accompanying top-selling prescription drugs

Aaron S. Kesselheim, Jessica M. Franklin, Jerry Avorn et al. · BMJ Quality & Safety · 2013 · 30 citations

, , +15

New and incremental FDA black box warnings from 2008 to 2015

Michael T. Solotke, Sanket S. Dhruva, Nicholas S. Downing et al. · Expert Opinion on Drug Safety · 2017 · 23 citations · Full text

, , +16

Risk Management Policy and Black-Box Warnings

Daniel M. Cook, Rama K. Gurugubelli, Lisa Bero · Drug Safety · 2009 · 21 citations

, , +13

1–5 of 9

Authors

23

  1. AS
    Aaron S. Kesselheim

    Brigham and Women's Hospital, United States

    2 publications · 42 citations

    2

    h-index

  2. JS
    James S. Yeh

    Brigham and Women's Hospital, United States

    1 publications · 12 citations

    1

    h-index

  3. SS
    Sanket S. Dhruva

    University of California, San Francisco, United States

    1 publications · 23 citations

    1

    h-index

  4. DM
    Daniel M. Cook

    University of Nevada, Reno, United States

    1 publications · 21 citations

    1

    h-index

  5. MH
    M. Hassan Murad

    Mayo Clinic, United States

    1 publications · 13 citations

    1

    h-index

1–5 of 23

Institutions

22

  1. Brigham and Women's Hospital

    Boston, United States

    3 h-index

    7 publications

    149 citations

  2. Harvard University

    Cambridge, United States

    2 h-index

    6 publications

    126 citations

  3. WinnMed

    Decorah, United States

    1 h-index

    1 publications

    13 citations

  4. Robert Wood Johnson Foundation

    Princeton, United States

    1 h-index

    2 publications

    46 citations

  5. The University of Texas at Austin

    Austin, United States

    1 h-index

    1 publications

    16 citations

  6. Yale University

    New Haven, United States

    1 h-index

    3 publications

    69 citations

  7. Austin College

    Sherman, United States

    1 h-index

    1 publications

    16 citations

  8. University of South Florida

    Tampa, United States

    1 h-index

    1 publications

    11 citations

1–8 of 22

Venues

  1. Drug Safety

    2 publications · 33 citations

    2

    h-index

  2. Expert Opinion on Drug Safety

    1 publications · 23 citations

    1

    h-index

  3. JAMA

    1 publications · 46 citations

    1

    h-index

  4. BMJ Quality & Safety

    1 publications · 30 citations

    1

    h-index

  5. New England Journal of Medicine

    NEJM · 1 publications · 334 citations

    1

    h-index

1–5