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8401491 
Journal Article 
Excipients «à effet notoire»: Analyse et mise à disposition des informations pour les professionnels de santé 
Fusier, I; Tollier, C; Husson, MC 
2004 
No 
Journal de Pharmacie Clinique
ISSN: 0291-1981 
23 
3 
149-156 
French 
The concept of excipients "with known effect" was officialized in France on June 12, 1999 with the publication of the generic drugs directory. Information on these excipients should be available to all health practitioners. The aim of this study was to make a descriptive and comparative analysis on all marketed drugs containing at least one excipient with known effect. Data on these excipients, retrived from official sources (Official Journal, RCP, EPAR) and the Thériaque database (http://www.theriaque.org), were analyzed by data-processing requests. The Official Journal referred 38 substances with known effect allowing to identify in Thériaque 300 excipients and their derivatives, 410 effects and/or recommendations. On June 2001, 62% of marketed drugs contained at least one excipient with known effect, and 65% in September 2003. Several issues were when evaluating existing information available to health professionnels: heterogeneous information among official sources, lack of precision of these official sources, and non-exhaustiveness of the excipients with known effect list. Since these excipient are frequently used in marketed drugs formulation, the potential side effects they may induce should not be underestimated by health practitioners. 
Drug database; Drug information; Excipient; Generic drug; OTC drug; Side effect