Interpretation of Pharmacovigilance Disproportionality Analyses.

Abstract

Clinical Pharmacology & TherapeuticsEarly View Letter to the Editor Interpretation of Pharmacovigilance Disproportionality Analyses Charles Khouri, Corresponding Author Charles Khouri [email protected] orcid.org/0000-0002-8427-8573 Pharmacovigilance Unit, Grenoble Alpes University Hospital, Grenoble, France Inserm U1300, HP2 Laboratory, Univ. Grenoble Alpes, Grenoble, FranceCorrespondence: Charles Khouri ([email protected])Search for more papers by this authorMichele Fusaroli, Michele Fusaroli Pharmacology Unit, Department of Medical and Surgical Sciences, University of Bologna, Bologna, ItalySearch for more papers by this authorFrancesco Salvo, Francesco Salvo INSERM, BPH, U1219, Team AHeaD, Univ. Bordeaux, Bordeaux, France Pôle de Santé Publique, Service de Pharmacologie Médicale, CHU de Bordeaux, Bordeaux, FranceSearch for more papers by this authorEmanuel Raschi, Emanuel Raschi orcid.org/0000-0003-0487-7996 Pharmacology Unit, Department of Medical and Surgical Sciences, University of Bologna, Bologna, ItalySearch for more papers by this author Charles Khouri, Corresponding Author Charles Khouri [email protected] orcid.org/0000-0002-8427-8573 Pharmacovigilance Unit, Grenoble Alpes University Hospital, Grenoble, France Inserm U1300, HP2 Laboratory, Univ. Grenoble Alpes, Grenoble, FranceCorrespondence: Charles Khouri ([email protected])Search for more papers by this authorMichele Fusaroli, Michele Fusaroli Pharmacology Unit, Department of Medical and Surgical Sciences, University of Bologna, Bologna, ItalySearch for more papers by this authorFrancesco Salvo, Francesco Salvo INSERM, BPH, U1219, Team AHeaD, Univ. Bordeaux, Bordeaux, France Pôle de Santé Publique, Service de Pharmacologie Médicale, CHU de Bordeaux, Bordeaux, FranceSearch for more papers by this authorEmanuel Raschi, Emanuel Raschi orcid.org/0000-0003-0487-7996 Pharmacology Unit, Department of Medical and Surgical Sciences, University of Bologna, Bologna, ItalySearch for more papers by this author First published: 30 May 2023 https://doi.org/10.1002/cpt.2951Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL No abstract is available for this article. References 1Prontskus, V. et al. COVID-19 vaccination and the incidence of De novo or recurrent rheumatoid arthritis: a French and international (VigiBase) signal detection study. Clin. Pharmacol. Ther. 113, 1107– 1116 (2023). 2Faillie, J.-L. Case-non-case studies: principle, methods, bias and interpretation. Therapie 74, 225– 232 (2019). 3Durand, J. et al. Safety monitoring of COVID-19 vaccines: perspective from the European medicines agency. Clin. Pharmacol. Ther. 113, 1223– 1234 (2023). 4Mouffak, A. et al. High prevalence of spin was found in pharmacovigilance studies using disproportionality analyses to detect safety signals: a meta-epidemiological study. J. Clin. Epidemiol. 138, 73– 79 (2021). 5Boutron, I. & Ravaud, P. Misrepresentation and distortion of research in biomedical literature. Proc. Natl. Acad. Sci. 115, 2613– 2619 (2018). 6Matthews, A. et al. Impact of statin related media coverage on use of statins: interrupted time series analysis with UK primary care data. BMJ 353, i3283 (2016). Early ViewOnline Version of Record before inclusion in an issue ReferencesRelatedInformation