AUTHOR=Valdiserra Giulia , Mores Nadia , Rocchi Rosalba Elisabetta , Sottosanti Laura , Felicetti Patrizia , Marchione Pasquale , Laurenti Luca , Fresa Alberto , Bucaneve Giampaolo , Cappello Emiliano , Bonaso Marco , Ferraro Sara , Convertino Irma , Tuccori Marco 

TITLE=Signal management and risk minimization strategy: a case study on obinutuzumab and non-overt disseminated intravascular coagulation

JOURNAL=Frontiers in Drug Safety and Regulation

VOLUME=Volume 3 - 2023

YEAR=2023

URL=https://www.frontiersin.org/journals/drug-safety-and-regulation/articles/10.3389/fdsfr.2023.1194683

DOI=10.3389/fdsfr.2023.1194683

ISSN=2674-0869

ABSTRACT=were reported 3 more ICSRs. The medical literature was poor of evidence about the possible association between obinutuzumab and DIC. The signal was subsequently validated, first by AIFA and then by EMA. The signal was confirmed by the Pharmacovigilance Risk Assessment Committee Rapporteur in the "signal confirmation" phase and it entered in the "signal analysis and prioritization" and the "signal assessment". In these phases, the PRAC assessed and confirmed DIC as a possible adverse reaction to obinutuzumab. Finally, the Summary of Product characteristics was updated with this new risk.Despite the intrinsic difficulties linked to the nature of the event itself, the process of the signal detection and the issuing of the risk minimization measures by the Italian Medicines Agency, as part of the EU procedures, has proven to be efficient.