Transparency and robustness of safety signals

Charles Khouri^{1

2}, Michele Fusaroli³, Francesco Salvo^{4

5}, Emanuel Raschi³

Affiliations

¹ Pharmacovigilance Department, Grenoble Alpes University Hospital, Grenoble, France.
² INSERM UMR 1300-Laboratory HP2, Grenoble Alpes University, Grenoble.
³ Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy.
⁴ Bordeaux Population Health, Research Centre 1219, University of Bordeaux, INSERM, Bordeaux, France.
⁵ Medical Pharmacology Department, Bordeaux University Hospital, Bordeaux.

Comment

Charles Khouri et al. BMJ. 2022.

. 2022 Nov 3:379:o2588.

doi: 10.1136/bmj.o2588.

Charles Khouri^{1

2}, Michele Fusaroli³, Francesco Salvo^{4

5}, Emanuel Raschi³

¹ Pharmacovigilance Department, Grenoble Alpes University Hospital, Grenoble, France.
² INSERM UMR 1300-Laboratory HP2, Grenoble Alpes University, Grenoble.
³ Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy.
⁴ Bordeaux Population Health, Research Centre 1219, University of Bordeaux, INSERM, Bordeaux, France.
⁵ Medical Pharmacology Department, Bordeaux University Hospital, Bordeaux.

No abstract available

Conflict of interest statement

Competing interests: CK, MF, FS, and ER are unpaid members of the READUS Group Steering Committee.

Characterization and corroboration of safety signals identified from the US Food and Drug Administration Adverse Event Reporting System, 2008-19: cross sectional study.
Dhodapkar MM, Shi X, Ramachandran R, Chen EM, Wallach JD, Ross JS. Dhodapkar MM, et al. BMJ. 2022 Oct 5;379:e071752. doi: 10.1136/bmj-2022-071752. BMJ. 2022. PMID: 36198428 Free PMC article.