Did the COVID-19 Pandemic Affect Contrast Media-Induced Adverse Drug Reaction’s Reporting? A Pharmacovigilance Study in Southern Italy

Abstract

Medical imaging is required for a complete clinical evaluation to identify lung involvement or pulmonary embolism during SARS-CoV-2 infection or pulmonary and cardiovascular sequelae. Contrast media (CM) have undoubtedly been useful in clinical practice due to their ability to improve medical imaging in COVID-19 patients. Considering their important use, especially in hospitalized COVID-19 patients, and that increased use of a medical tool could also be associated with its deeper knowledge, we chose to explore if new information emerged regarding CM safety profiles. We analyzed all Individual Case Safety Reports (ICSRs) validated by Campania Pharmacovigilance Regional Centre from 1 January 2018 to 31 December 2021 and reported a CM (ATC code V08) as a suspected drug. We compared CM-related reporting between 2 years before (period 1) and 2 years during (period 2) the COVID-19 pandemic. From our analysis, it emerged that, during the COVID-19 pandemic, CM-related ADR reporting decreased, but a significant increase in reporting of serious cases emerged. Serious ADRs were mainly related to iodinated CM (V08A ATC) compared to magnetic resonance imaging CM (V08C ATC). Cutaneous and respiratory disorders were the most frequently reported in both periods. No new or unknown ADRs were reported in the overall study period.

Safety Monitoring of mRNA COVID-19 Vaccines in Children Aged 5 to 11 Years by Using EudraVigilance Pharmacovigilance Database: The CoVaxChild Study

“…This result highly differs from what has been observed in the spontaneous reporting “history”, where healthcare professionals have been always the most common source. These findings could be due to both the unprecedented attention paid to COVID-19 vaccines especially from citizens and to greater awareness of patients about the spontaneous reporting of suspected adverse drug/vaccine events [ 15 ].…”

Real-World Safety Data of the Orphan Drug Onasemnogene Abeparvovec (Zolgensma®) for the SMA Rare Disease: A Pharmacovigilance Study Based on the EMA Adverse Event Reporting System

“…This result, as well as the major distribution in terms of the reporter type in favor of HPs, is in line with the analysis conducted by Zhuang et al on the US database [ 33 ]. As described in other studies, HPs represent the major reporting source, even if, to date, citizens can also send safety reports to regulatory authorities [ 36 , 37 ]. The distribution of reports by age group of patients is also comparable, although not completely coincident.…”

Glucagon-like Peptide-1 Receptor Agonists and Suicidal Ideation: Analysis of Real-Word Data Collected in the European Pharmacovigilance Database

“…Multiple biological factors can also contribute to the pathophysiology of adverse events [ 27 , 28 ], including suicidal events [ 29 ]. Among these, sex can contribute to suicidal behaviours.…”