Balancing risk in ophthalmic prescribing: assessing the safety of anti-VEGF therapies and the risks associated with unlicensed medicinesReportar como inadecuado




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Graefe-s Archive for Clinical and Experimental Ophthalmology

, Volume 250, Issue 11, pp 1563–1571

First Online: 12 August 2012Received: 05 April 2012Revised: 01 July 2012Accepted: 23 July 2012

Abstract

Vascular endothelial growth factor VEGF inhibitor medications such as ranibizumab, pegaptanib and bevacizumab are in use for the treatment of neovascular age-related macular degeneration AMD and other retinal conditions, although only ranibizumab and pegaptanib are approved for these conditions. In contrast, bevacizumab was developed for the intravenous systemic treatment of colorectal cancer and is not formulated for intravitreal use, but is commonly used off-label in ophthalmology. European Union legislation permits the use of drugs outside the terms of their licence ‘off-label’ only under certain circumstances, such as during clinical trials, compassionate-named patient use in the absence of a licensed alternative, emergency scenarios e.g., pandemics or at the discretion of a treating physician. In such cases, patients should be fully informed regarding their treatment and any potential risks involved. Off-label drug use can be an important tool to provide patients with treatment in cases of unmet medical need. However, the use of an unlicensed medicinal product, when a suitable licensed alternative is available, puts prescribing physicians at risk of liability if safety issues arise. Emerging clinical evidence suggests safety differences exist between ranibizumab and bevacizumab.

KeywordsMedication safety Off-label prescribing Ranibizumab Bevacizumab Age-related macular degeneration An erratum to this article can be found at http:-dx.doi.org-10.1007-s00417-012-2230-2.

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Autor: Peter K. Kaiser - Alan F. Cruess - Peter Bogaert - Kamlesh Khunti - Simon P. Kelly

Fuente: https://link.springer.com/







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