Isabelle Fusier1, Corinne Tollier, Marie Caroline Husson. 1. Centre National Hospitalier d'Information sur le Médicament, CNHIM-Hôpital de Bicêtre, 78, rue du général Leclerc, BP11, 94272 Le Kremlin Bicêtre, France. fusier@wanadoo.fr
Abstract
OBJECTIVE: The 13/01/01 French decree published an official list of brands and their generic drugs and identified 38 groups of excipients with known effects which are responsible for side effects and contraindication respectively. Our objective was to review all medicines marketed in France containing these excipients and to disseminate this information to French health care practitioners. METHOD: The side effects and contraindications regarding these excipients have been documented in the French drug database Thériaque (http://www.theriaque.org). They were documented for each medicine containing these excipients in addition to the data mentioned in the Summary of Product Characteristics (SPC). Results were obtained on 1 June 2001 by using computerised queries from the database. RESULTS: Within the 38 groups, 300 specific excipients and derivatives with known effects were identified. Among the 8900 medicines (100%), 5567 medicines (62.6%) contained one or more of these excipients; 2483 contained 1 excipient, 1819 contained 2 excipients and 1265 contained 3 or more excipients; 410 side effects or contra-indications--were described according to the route of administration and the threshold dose. They were linked to these 5567 medicines; 5818 excipients with a threshold dose were mentioned in the 'composition' sections of these 5567 medicines. Among these 5818 excipients, 3385 quantitative doses were documented in the SPCs or EPARs. CONCLUSION: This review shows the extent of most of the excipients contained in medicines marketed in France. The dissemination of these data offsets the lack of information in the SPCs.
OBJECTIVE: The 13/01/01 French decree published an official list of brands and their generic drugs and identified 38 groups of excipients with known effects which are responsible for side effects and contraindication respectively. Our objective was to review all medicines marketed in France containing these excipients and to disseminate this information to French health care practitioners. METHOD: The side effects and contraindications regarding these excipients have been documented in the French drug database Thériaque (http://www.theriaque.org). They were documented for each medicine containing these excipients in addition to the data mentioned in the Summary of Product Characteristics (SPC). Results were obtained on 1 June 2001 by using computerised queries from the database. RESULTS: Within the 38 groups, 300 specific excipients and derivatives with known effects were identified. Among the 8900 medicines (100%), 5567 medicines (62.6%) contained one or more of these excipients; 2483 contained 1 excipient, 1819 contained 2 excipients and 1265 contained 3 or more excipients; 410 side effects or contra-indications--were described according to the route of administration and the threshold dose. They were linked to these 5567 medicines; 5818 excipients with a threshold dose were mentioned in the 'composition' sections of these 5567 medicines. Among these 5818 excipients, 3385 quantitative doses were documented in the SPCs or EPARs. CONCLUSION: This review shows the extent of most of the excipients contained in medicines marketed in France. The dissemination of these data offsets the lack of information in the SPCs.