Off-label use of medicines: consensus recommendations for evaluating appropriateness

Allen C Cheng, Priscilla M Robinson and Ken Harvey
Med J Aust 2007; 186 (7): . || doi: 10.5694/j.1326-5377.2007.tb00947.x
Published online: 2 April 2007

To the Editor: We write in response to recently published consensus recommendations for the off-label use of pharmaceuticals, which provide a common-sense, evidence-based approach to a commonly encountered clinical problem.1 The recommendations indicate that, other than for exceptional or research indications, off-label use of a medicine is generally not recommended unless there is high-quality evidence supporting such use. However, for some older pharmaceuticals, there is little incentive to perform additional trials to generate good evidence to support off-label use.

  • Allen C Cheng1
  • Priscilla M Robinson2
  • Ken Harvey2

  • 1 Department of Medicine, University of Melbourne, Melbourne, VIC.
  • 2 School of Public Health, La Trobe University, Melbourne, VIC.


Competing interests:

Allen Cheng and Ken Harvey have been external drug evaluators for the Therapeutic Goods Administration.


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