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Is off-label use of drugs legal?
Anyone who has attended ophthalmology conferences recently cannot fail to notice the enthusiasm of retinal specialists in adopting the new treatment, Avastin. Avastin is a humanised monoclonal antibody against vascular endothelial growth factor: an important growth factor for angiogenesis. The labelled indication of Avastin is for the treatment of colon cancer. Its use in the eye is therefore off label; no robust scientific data exist on its safety and efficacy; all the positive reports have short follow-ups. The clamour to introduce this treatment raises several ethical issues.
IS IT LEGAL?
Off-label use of drugs is not illegal. Physicians and surgeons are allowed to do this. It is not uncommon. In a paediatric hospital ward setting, almost half the prescriptions are unlicensed or are off label.1 Intravitreal Triamcinolone, tissue plasminogen activators, intracameral Vancomycin or Lignocaine are just a few off-label drugs used in ophthalmology. The fact that it is common practice does not make it safe. There may be a risk of unexpected adverse outcomes, but this is also true of labelled use of new drugs. Some adverse effects do not become apparent until after several years of use or many thousands of prescriptions; Vioxx2 is a good example.
APPROVED AND PROVEN
Approved and proven are not synonymous terms, especially with new treatment. A treatment can be proven effective and safe but not be approved because it is too costly. Good evidence from randomised control trials (RCT) shows that photodynamic therapy (PDT) compared to no treatment is effective in predominantly classic lesions.3 The National Institute for Health and Clinical Excellence (NICE) does not recommend PDT for predominantly classic …
Competing interests: None declared.
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