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

American Journal of Ophthalmology

Volumn 147, Issue 5, 2009, Pages 761-763

  Rosenfeld, Philip J ^a   Goodman, Kenneth W ^b  

^a UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; INFLIXIMAB; RANIBIZUMAB;

CLINICAL RESEARCH; COST EFFECTIVENESS ANALYSIS; DISEASE COURSE; DRUG APPROVAL; DRUG COST; DRUG EFFICACY; DRUG SAFETY; EDITORIAL; HUMAN; LOADING DRUG DOSE; NONHUMAN; OFF LABEL DRUG USE; PRIORITY JOURNAL; RETINA MACULA AGE RELATED DEGENERATION; TREATMENT INDICATION; TREATMENT OUTCOME; VISUAL ACUITY;

ANTIBODIES, MONOCLONAL; CHOROIDAL NEOVASCULARIZATION; COST-BENEFIT ANALYSIS; DRUG APPROVAL; ETHICS, MEDICAL; HUMANS; INJECTIONS; MACULAR DEGENERATION; PHYSICIAN-PATIENT RELATIONS; TUMOR NECROSIS FACTOR-ALPHA; VITREOUS BODY;

EID: 64349114475     PISSN: 00029394     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ajo.2009.01.011     Document Type: Editorial

References (9)

1. Theodossiadis P.G., Liarakos V.S., Sfikakis P.P., Vergados I.A., and Theodossiadis G.P. Intravitreal administration of the anti-tumor necrosis factor agent infliximab for neovascular age-related macular degeneration. Am J Ophthalmol 147 (2009) 825-830
2. Rosenfeld P.J., Brown D.M., Heier J.S., et al. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med 355 (2006) 1419-1431
3. Brown D.M., Michels M., Kaiser P.K., et al. Ranibizumab versus verteporfin for neovascular age-related macular degeneration: two-year results of the ANCHOR Study. Ophthalmology 116 (2009) 57-65 e5
4. Ranibizumab prescribing information (package insert). http://www.gene.com/gene/products/information/pdf/lucentis-prescribing.pdf Accessed: January 10, 2009
5. Infliximab prescribing information (package insert). http://www.centocor.com/centocor/assets/remicade.pdf#zoom=100 Accessed: January 10, 2009
6. Markomichelakis N.N., Theodossiadis P.G., and Sfikakis P.P. Regression of neovascular age-related macular degeneration following infliximab therapy. Am J Ophthalmol 139 (2005) 537-540
7. Theodossiadis P.G., Liarakos V.S., Sfikakis P.P., et al. Intravitreal administration of the anti-TNF monoclonal antibody infliximab in the rabbit. Graefes Arch Clin Exp Ophthalmol 247 (2009) 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.htm Accessed: January 10, 2009
9. Goodman K.W. Ethics and Evidence-Based Medicine: Fallibility and Responsibility in Clinical Science (2003), Cambridge University Press, Cambridge