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G Danan

Publications and source records attributed to G Danan.

51 records · Page 3Linked to original sources
PubMedDate not supplied

[Drug-induced cutaneous photosensitivity. Results of a consensus meeting].

In France, the use of an official drug adverse reaction assessment method is mandatory since 1984. The method proposes various qualifications for chronologic and semiologic criteria without clear limits. The definitions could vary with the nature of the side-effect. We report here the results of a consensus meeting on drug-induced photosensitivity. Dermatologists and experts in pharmacovigilance studied together how the "French method" could apply to the two variances of drug-induced photosensitivity: phototoxicity and photoallergy.

Drug Eruptions↗
PubMedDate not supplied

[Interstitial pneumopathies: criteria of drug side-effects. Results of consensus meetings].

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.

Chronology as Topic↗
PubMedDate not supplied

[Criteria of imputation of acute hepatitis to a drug. Results of consensus meetings].

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.

Acute Disease↗
PubMedDate not supplied

[Drugs and patient information. Writing of instructions].

The main accusation against package inserts is that they are not understood by the patients: the vocabulary used is uncommon and the information is not always relevant. A recent European directive on package inserts for drugs concerning human use specifies the items that must be mentioned. Following this directive and regarding patient interest, a presentation for notices is proposed in which the subject headings are presented as questions and the text is a guide to drug practical use to provide the elements of surveillance. A summarized version added to this detailed notice for the convenience of the patient is also proposed, which should be translated into the language of each European Community's member state.

Drug Labeling↗
PubMedDate not supplied

[Good practices of publication of clinical cases of pharmacovigilance: comments, Groupe de Travail sur les Bonnes Pratiques de Publication de Cliniques en Pharmacovigilance: commentary].

This paper introduces some comments on the complete text of Good Pharmacovigilance Publishing Practices, which forms appendix number 2 of the Good Pharmacovigilance Practices now published by the French Drug Agency, as was Good Clinical Practices. Each good practice is printed in italic and presented in a frame; the following comments are designed to facilitate its application. The technical terms that are used in this text are presented according to the glossary in Good Pharmacovigilance Practices.

Adverse Drug Reaction Reporting Systems↗