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