Abstract
Remdesivir was recommended for hospitalized patients with COVID-19. As already reported in the Summary of Product Characteristics, most of remdesivir’s safety concerns are hepatoxicity and nephrotoxicity related. However, some cases have raised concerns regarding the potential cardiac events associated with remdesivir; therefore, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency requested to investigate all available data. Therefore, we analyzed all Individual Case Safety Reports (ICSRs) collected in the EudraVigilance database focusing on cardiac adverse events. From April to December 2020, 1375 ICSRs related to remdesivir were retrieved from EudraVigilance, of which 863 (62.8%) were related to male and (43.3%) adult patients. A total of 82.2% of all AEs (N = 2604) was serious and one third of the total ICSRs (N = 416, 30.3%) had a fatal outcome. The most frequently reported events referred to hepatic/hepatobiliary disorders (19.4%,), renal and urinary disorders (11.1%) and cardiac events (8.4%). Among 221 cardiac ICSRs, 69 reported fatal outcomes. Other drugs for cardiovascular disorders were reported as suspected/concomitant together with remdesivir in 166 ICSRs (75.1%), 62 of which were fatal. Moreover, the mean time to overall cardiac event was 3.3 days (±2.2). Finally, disproportionality analysis showed a two-fold increased risk of reporting a cardiac adverse event associated with remdesivir compared to both hydroxychloroquine and azithromycin. This study showed that remdesivir could be associated to risk of cardiac events, suggesting a potential safety signal which has not been completely evaluated yet. Further studies are needed to confirm these findings.
Highlights
Licensee MDPI, Basel, Switzerland.Remdesivir, a broad-spectrum antiviral agent, which inhibits viral RNA-dependentRNA polymerase, was the first treatment in Europe recommended with conditional marketing authorization to treat coronavirus disease 2019 (COVID-19) [1]
Almost all the Individual Case Safety Reports (ICSRs) were issued by healthcare professional (N = 1349, 98.1%) and the majority occurred in the non-European Economic Area (N = 866, 63.0%) (Table 1)
The full resolution of events was reported in one fourth of ICSRs (N = 338), an improvement was seen in 151 cases (11.0%), while events were not resolved yet in 186 patients
Summary
RNA polymerase, was the first treatment in Europe recommended with conditional marketing authorization to treat coronavirus disease 2019 (COVID-19) [1]. This recommendation was based on the positive results in terms of time to recovery for hospitalized COVID-19 patients [2]. Pharmaceuticals 2021, 14, 611 regardless of disease severity, since the lack of evidence of survival improvement and other clinical outcomes in these patients This recommendation was clearly reported in the third version (update two) of the living guideline developed by the WHO in collaboration with the non-profit Magic Evidence Ecosystem Foundation (MAGIC) [3]. According to the RMP, further efficacy and safety data are routinely collected through on-going studies and post-marketing reports and will be regularly reviewed by the Committee for Medicinal Products for Human Use (CHMP) and Pharmacovigilance
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