Interpretation of Pharmacovigilance Disproportionality Analyses

Charles Khouri^{1

2}, Michele Fusaroli³, Francesco Salvo^{4

5}, Emanuel Raschi³

Affiliations

¹ Pharmacovigilance Unit, Grenoble Alpes University Hospital, Grenoble, France.
² Inserm U1300, HP2 Laboratory, Univ. Grenoble Alpes, Grenoble, France.
³ Pharmacology Unit, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
⁴ INSERM, BPH, U1219, Team AHeaD, Univ. Bordeaux, Bordeaux, France.
⁵ Pôle de Santé Publique, Service de Pharmacologie Médicale, CHU de Bordeaux, Bordeaux, France.

Comment

Charles Khouri et al. Clin Pharmacol Ther. 2023 Oct.

. 2023 Oct;114(4):745-746.

doi: 10.1002/cpt.2951. Epub 2023 May 30.

Charles Khouri^{1

2}, Michele Fusaroli³, Francesco Salvo^{4

5}, Emanuel Raschi³

¹ Pharmacovigilance Unit, Grenoble Alpes University Hospital, Grenoble, France.
² Inserm U1300, HP2 Laboratory, Univ. Grenoble Alpes, Grenoble, France.
³ Pharmacology Unit, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
⁴ INSERM, BPH, U1219, Team AHeaD, Univ. Bordeaux, Bordeaux, France.
⁵ Pôle de Santé Publique, Service de Pharmacologie Médicale, CHU de Bordeaux, Bordeaux, France.

No abstract available

Comment in

Reply to "Interpretation of Pharmacovigilance Disproportionality Analyses".
Prontskus V, Fresse A, Yelehe M, Beurrier M, Gillet P. Prontskus V, et al. Clin Pharmacol Ther. 2023 Oct;114(4):747. doi: 10.1002/cpt.2950. Epub 2023 Jun 1. Clin Pharmacol Ther. 2023. PMID: 37259792 No abstract available.

COVID-19 Vaccination and the Incidence of De Novo or Recurrent Rheumatoid Arthritis: A French and International (VigiBase) Signal Detection Study.
Prontskus V, Fresse A, Yelehe-Okouma M, Facile A, Pietri T, Simon C, Le Souder C, Beurrier M, Gillet P; French network of Regional Pharmacovigilance Centres. Prontskus V, et al. Clin Pharmacol Ther. 2023 May;113(5):1107-1116. doi: 10.1002/cpt.2866. Epub 2023 Feb 27. Clin Pharmacol Ther. 2023. PMID: 36752604

1. Prontskus, 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).
1. Faillie, J.-L. Case-non-case studies: principle, methods, bias and interpretation. Therapie 74, 225-232 (2019).
1. Durand, J. et al. Safety monitoring of COVID-19 vaccines: perspective from the European medicines agency. Clin. Pharmacol. Ther. 113, 1223-1234 (2023).
1. Mouffak, 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).
1. Boutron, I. & Ravaud, P. Misrepresentation and distortion of research in biomedical literature. Proc. Natl. Acad. Sci. 115, 2613-2619 (2018).