[Aesthetics and mortal risk].
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Biomedical subjects
Publications and source records attributed to B Begaud.
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Since 1984, the use of the official method for determining the responsibility of drugs in side-effects has been compulsory in France. This method offers, but does not define, different qualificatives for chronological and semeiological criteria. Consensus workshops have been set up to define the undesirable side-effects themselves and the different qualificatives in each of the principal fields of pathology. As regards drug-induced interstitial pneumonia, chest specialists from university hospitals, members of the national system of pharmacovigilance and representatives of the Roussel-Uclaf central department of pharmaco-vigilance have determined: the limits of time elapsed between the beginning and end of drug administration and the occurrence of the adverse reaction; how to interpret various courses of the side-effect with and without temporary discontinuation of the drug, and how to interpret a possible readministration. A list of investigations aimed at excluding the main possible causes of interstitial pneumonia has been drawn up.
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The use of an official drug adverse reaction assessment procedure became compulsory in France in 1984. The method proposes various qualifications for chronologic and semiologic criteria but does not define them. Consensus meetings have been organized in order to define, in the main pathologic fields, the adverse reactions themselves and the various qualifications of the criteria. This paper reports the results of meetings attended by hepatologists from university hospitals, members of the National Network of pharmacovigilance and representatives of Roussel Uclaf Drug Monitoring Department for drug-induced acute hepatitis. Participants studied (a) the limits of the time interval between the appearance of the adverse reaction and the beginning or the end of the treatment with the suspected drug; (b) the interpretation of the course of disease with or without cessation of treatment; (c) the interpretation of a possible rechallenge; (d) the signs evoking a drug-induced origin and the risk factors, as well as the investigations to be performed in order to eliminate other possible causes.
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