Adverse drug reactions terminology

There is considerable confusion in the use of terminology in this area. Edwards and Aronson proposed the following definition. An adverse drug reaction is an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention... 

This is a completely new edition of what has become the standard reference text in the field of adverse drug reactions and interactions since Leopold Meyler published his first review of the subject 55 years ago. Although we have retained the old title, Meyler s Side Effects of Drugs, the subtitle of this edition, The Encyclopedia of Adverse Drug Reactions and Interactions, reflects both modern terminology and the scope of the review. The structure of the book may have changed, but the Encyclopedia remains the most comprehensive reference source on adverse drug reactions and interactions and a major source of informed discussion about them. 

The varying nomenclature used to describe safety data in clinical trials can be confusing. Terms used include adverse events, adverse experiences, adverse drug reactions, side effects, severe adverse events, significant adverse events, tteattnent-emeigent adverse events, adverse events of special interest, and toxidties. We therefore endeavor to bring some consistency to this terminology. 

Terminology Classification of Adverse Drug Reactions and the terms Hypersensitivity, and Allergy... 

To support approval as a nonbotanical drug, adequate and well-controlled clinical studies are required. Not only must the treatment be shown to be effective, with real patient benefits in morbidity and/or mortality to justify the safety risk of adverse reactions as observed, but the clinical data must also provide practical instructions for use, which can be reasonably followed by health care professionals. There is no reason why these requirements should be different for botanical drugs, because patient suffering and treatment benefits are independent of medical theory or practice. Regardless of medical systems and terminology used, courses of diseases/conditions should be established and treatment effects must be clinically meaningful. Incorporation of alternative medical practice into the clinical studies will be acceptable if the new set of instructions derived from such studies will be practical. 

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