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Journal of General Internal Medicine

, Volume 26, Issue 6, pp 603–610 | Cite as

Different Black Box Warning Labeling for Same-Class Drugs

  • Orestis A. Panagiotou
  • Despina G. Contopoulos-Ioannidis
  • Panagiotis N. Papanikolaou
  • Evangelia E. Ntzani
  • John P. A. Ioannidis
Original Research

ABSTRACT

INTRODUCTION

Black box warnings (BBWs) are the strongest medication-related safety warnings in a drug’s labeling information and highlight major risks. Absence of a BBW or asynchronous addition of a BBW among same-class drugs could have major implications.

METHODS

We identified the 20 top-selling drugs in 2008 (10 with BBWs and 10 without BBWs on their label) that belonged to different drug classes. We collected labeling information on all drugs belonging in these 20 classes, and recorded differences in the presence and timing of acquisition of BBWs for same-class drugs.

RESULTS

Across the 20 evaluated drug classes, we identified 176 different agents, of which 7 had been withdrawn for safety reasons. The reasons for the withdrawals became BBWs in other same-class agents only in two of the seven cases. Differences were identified in 9 of the 20 classes corresponding to 15 BBWs that were not present in all drugs of the same class. The information for 10 of the 15 different BBWs were included in the labels of same-class drugs as simple warnings or text, while it was absent entirely in 5 BBWs. The median interval from the time the BBW had appeared in another drug of the same class was 66 months.

DISCUSSION

Differences in BBW labeling in same-class drugs are common and shape impressions about the safety of similar agents. BBW labeling needs to become more systematic.

KEY WORDS

black-box warning FDA adverse events harms 

Notes

Acknowledgements

There was no funding for this study.

Conflicts of Interest

None disclosed.

Supplementary material

11606_2011_1633_MOESM1_ESM.doc (236 kb)
Appendix Tables 1–2 (DOC 236 kb)

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Copyright information

© Society of General Internal Medicine 2011

Authors and Affiliations

  • Orestis A. Panagiotou
    • 1
  • Despina G. Contopoulos-Ioannidis
    • 2
    • 3
  • Panagiotis N. Papanikolaou
    • 1
  • Evangelia E. Ntzani
    • 1
  • John P. A. Ioannidis
    • 1
    • 4
    • 5
    • 6
    • 7
  1. 1.Department of Hygiene and EpidemiologyUniversity of Ioannina School of MedicineIoanninaGreece
  2. 2.Department of PediatricsUniversity of Ioannina School of MedicineIoanninaGreece
  3. 3.Division of Infectious DiseasesDepartment of Medicine, Stanford University School of MedicineStanfordUSA
  4. 4.Foundation for Research and Technology- HellasBiomedical Research InstituteIoanninaGreece
  5. 5.Stanford Prevention Research CenterStanford University School of MedicineStanfordUSA
  6. 6.Institute for Clinical Research and Health Policy Studies, Tufts Medical CenterTufts University School of MedicineBostonUSA
  7. 7.Department of EpidemiologyHarvard School of Public HealthBostonUSA

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