Abstract

and makes this article in addition to the manuscript published by Bhala et al. [2] the basis of their recent PRAC (Pharmacovigilance Risk Assessment Committee)recommendations (EMA/353084/2013). Indeed, the study deserves specific attention: It appears especially credible since it has been funded by European governmental organizations and not by drug industry. For the same reason it deserves scrutiny and caution. The statement in the abstract of the publication that ‘for diclofenac... the risk of acute myocardial infarctions, AMI, was increased at low and high doses’ has found worldwide attention. It stigmatizes diclofenac as comparatively dangerous even in low doses with respect to cardiovascular events. Indeed, diclofenac would deserve specific risk precautions if the conclusions of this article would be correct, consistent and plausible.

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