Year: 2026
Type: article
Abstract: The primary objective of pharmacovigilance is the early detection and characterization of safety signals, defined as information suggesting new potential causal association between a medicinal product and an adverse event requiring further investigation. The French pharmacovigilance system is characterized by a decentralized organization relying on Regional Pharmacovigilance Centres, which provide in-depth clinical and pharmacological assessment of adverse drug reaction reports before their transmission to health authorities. The individual assessment of spontaneous adverse drug reaction reports, combined with quantitative analyses of pharmacovigilance databases (disproportionality analysis), is a key tool for safety signal detection. However, data from pharmacovigilance databases must be interpreted with caution. Causality between reported adverse reactions and the suspected drug remains uncertain due to several limitations, including incomplete information, diagnostic uncertainty, and potential confounding factors. Furthermore, the number of reported cases cannot be used to estimate the incidence of adverse reactions in the general population, notably because of selective reporting and limited data on the actual number of exposed patients. Disproportionality analyses, which are widely used to identify drug–adverse reaction associations, are useful for hypothesis generation. However, they cannot establish causality or quantify risk and are subject to numerous biases. Therefore, safety signals should be considered hypotheses requiring a multimodal assessment integrating clinical, pharmacological, and epidemiological data. Rigorous interpretation of these data is essential to avoid misleading conclusions that could have public health implications. The purpose of this work is to develop an educational tool to support the understanding and interpretation of data and signal detection analyses performed using pharmacovigilance databases.
Source: Therapies
Authors: Charles Khouri, Virginie Bres, Marion Allouchery, Romain Barus, Delphine Bourneau-Martin, Clément Cholle, Laurent Chouchana, Judith Cottin, Sophie Fedrizzi, Alex Hlavaty, Bérenger Largeau, Nathalie Massy, Anne-Lise Ruellan, Lucie-Marie Scailteux, Thomas Soeiro, Laure Thomas, Aurélie Grandvuillemin, Jean-Luc Faillie
Institutions: Centre Hospitalier Universitaire de Grenoble, Université Grenoble Alpes, Centre Hospitalier Universitaire de Montpellier, Centre Hospitalier Universitaire de Poitiers, Centre Hospitalier Universitaire de Toulouse, Centre Hospitalier Universitaire d'Angers, Centre Hospitalier Universitaire de Bordeaux, Hôpital Cochin, Assistance Publique – Hôpitaux de Paris, Hospices Civils de Lyon, Centre Hospitalier Universitaire de Caen Normandie, Centre Hospitalier Universitaire de Tours, Centre Hospitalier Universitaire de Nantes, Centre Hospitalier Universitaire de Rennes, Assistance Publique Hôpitaux de Marseille, Hôpitaux Universitaires Henri-Mondor, CHU Dijon Bourgogne
Language: English
Subfield: Toxicology
Domain: Life Sciences
Open Access status: hybrid
Estimated APC paid: $3,450
OpenAlex ID: W7223265761