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.

  • 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.

  • 1. Gazarian M, Kelly M, McPhee JR, et al. Off-label use of medicines: consensus recommendations for evaluating appropriateness. Med J Aust 2006; 185: 544-548. <MJA full text>
  • 2. Therapeutic guidelines: antibiotics. 12th ed. Melbourne: Therapeutic Guidelines Ltd, 2003.
  • 3. Baddour LM, Wilson WR, Bayer AS, et al. Infective endocarditis: diagnosis, antimicrobial therapy, and management of complications. Circulation 2005; 111: e394-e434.
  • 4. Schrenzel J, Harbarth S, Schockmel G, et al. A randomized clinical trial to compare fleroxacin-rifampicin with flucloxacillin or vancomycin for the treatment of staphylococcal infection. Clin Infect Dis 2004; 39: 1285-1292.
  • 5. Cheng AC. Antibiotics for unapproved indications. Australian Prescriber 2006; 29: 4-5.


remove_circle_outline Delete Author
add_circle_outline Add Author

Do you have any competing interests to declare? *

I/we agree to assign copyright to the Medical Journal of Australia and agree to the Conditions of publication *
I/we agree to the Terms of use of the Medical Journal of Australia *
Email me when people comment on this article

Online responses are no longer available. Please refer to our instructions for authors page for more information.