To the Editor: The letter from Smith and colleagues in the 6 June 2011 issue of the Journal1 highlights the potential toxicity of colchicine, even when used in the therapeutic doses recommended in the current product information (PI).2 This in turn highlights how important it is that all medicines have PI that continues to be maintained with the most clinically accurate and up-to-date information. The current system for maintaining PI seems to break down most significantly with out-of-patent, “grandfathered” and “orphan” medicines.3
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