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Biomedical subjects

C Benichou

Publications and source records attributed to C Benichou.

36 records · Page 2Linked to original sources

Articular cartilage atrophy in lower limb amputees.

A retrospective and radiologic survey of the hips of 53 above-knee amputees showed that none of these hips was normal. Osteoporosis was present in all subjects, and cartilage thickness was reduced in 27 cases. This reduced thickness was inversely correlated with stump length, since it occurred in 11 of 13 upper-third amputees, but in none of 10 lower-third amputees. The mechanisms of cartilage atrophy are discussed.

Adult↗

[International reporting of adverse drug reactions. Final report of CIOMS ADR Working Group].

Under the auspices of the Council for International Organizations of Medical Sciences, a working group composed of representatives of seven multinational pharmaceutical manufacturers and six regulatory authorities developed and implemented a standardized method for reporting post-approval adverse drug reactions (ADR). The method is based on a set of uniform definitions and procedures and a single reporting form, and has been demonstrated to be feasible and effective. Regulators and manufacturers, in establishing requirements and systems for reporting of adverse drug reactions, should consider adopting this method.

Drug-Related Side Effects and Adverse Reactions↗

[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↗

[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↗

Points of view on adverse drug reactions terminology.

Global management of drug safety data is the best way to make the detection and validation of adverse drug reactions (ADRs) earlier. Centralization needs a previous standardization, of which terminology is a crucial component. ADR terminology must be designed so as to enable users to know exactly what is covered by each term regarding the nature of the reaction and its significance for public health. A worldwide standardized terminology for all drug reporting purposes is currently being developed by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. However, practical definitions of medical terms will be necessary and could be developed by specialists on drug safety in collaboration with specialists of different system organs, as has already been achieved for some of them.

Drug-Related Side Effects and Adverse Reactions↗