American Journal of Ophthalmology
Volume 147, Issue 5 , Pages 761-763 , May 2009

When Is Off-Label Drug Use in the Patient's Best Interest?

  • Philip J. Rosenfeld

      Affiliations

    • Bascom Palmer Eye Institute, Department of Ophthalmology, University of Miami Miller School of Medicine, Miami, Florida
    • Corresponding Author InformationInquiries to Philip J. Rosenfeld, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, 900 NW 17th Street, Miami, FL 33136
    • ,
  • Kenneth W. Goodman

      Affiliations

    • Department of Medicine and Director of the Bioethics Program, Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida

,Accepted 26 January 2009.

References 

  1. Theodossiadis PG, Liarakos VS, Sfikakis PP, Vergados IA, Theodossiadis GP. Intravitreal administration of the anti-tumor necrosis factor agent infliximab for neovascular age-related macular degeneration. Am J Ophthalmol. 2009;147:825–830
  2. Rosenfeld PJ, Brown DM, Heier JS, et al. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006;355:1419–1431
  3. Brown DM, Michels M, Kaiser PK, et al. Ranibizumab versus verteporfin for neovascular age-related macular degeneration: two-year results of the ANCHOR Study. Ophthalmology. 2009;116:57–65e5
  4. Ranibizumab prescribing information (package insert). http://www.gene.com/gene/products/information/pdf/lucentis-prescribing.pdfAccessed: January 10, 2009
  5. Infliximab prescribing information (package insert). http://www.centocor.com/centocor/assets/remicade.pdf#zoom=100Accessed: January 10, 2009
  6. Markomichelakis NN, Theodossiadis PG, Sfikakis PP. Regression of neovascular age-related macular degeneration following infliximab therapy. Am J Ophthalmol. 2005;139:537–540
  7. Theodossiadis PG, Liarakos VS, Sfikakis PP, et al. Intravitreal administration of the anti-TNF monoclonal antibody infliximab in the rabbit. Graefes Arch Clin Exp Ophthalmol. 2009;247:273–281
  8. Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htmAccessed: January 10, 2009
  9. Goodman KW. Ethics and Evidence-Based Medicine: Fallibility and Responsibility in Clinical Science. Cambridge: Cambridge University Press; 2003;

 See accompanying Article on page 825.

PII: S0002-9394(09)00061-0

doi: 10.1016/j.ajo.2009.01.011

American Journal of Ophthalmology
Volume 147, Issue 5 , Pages 761-763 , May 2009

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