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Conclusiveness of rechallenge in the interpretation of adverse drug reactions.
Author(s) -
Girard M
Publication year - 1987
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/j.1365-2125.1987.tb03011.x
Subject(s) - causality (physics) , terminology , medicine , outcome (game theory) , adverse effect , interpretation (philosophy) , typology , pharmacovigilance , drug , drug reaction , intensive care medicine , event (particle physics) , risk analysis (engineering) , computer science , pharmacology , mathematics , philosophy , linguistics , physics , mathematical economics , archaeology , quantum mechanics , history , programming language
We here consider the extent to which the presumed correlation between an adverse event and the administration of a particular drug can be reinforced by rechallenge. At first question of terminology is: what is a rechallenge? Rechallenge is often accepted too readily as proof of a causal relationship and clinical examples give illustrations of common misinterpretations. Definitions are proposed to characterize: the outcome of rechallenge; the conditions under which rechallenge is performed. In discussing causality, a sharp distinction is drawn between the outcome per se and the establishment of a causal relationship. Finally, the simple concepts proposed here should permit to establish a typology of rechallenge and to assess, by further experimental or retrospective research, the conclusiveness of rechallenge in interpreting adverse drug reactions.