Adverse drug events in the prevention and treatment of COVID-19: A data mining study on the FDA adverse event reporting system

Abstract

Background: In the emergent situation of COVID-19, off-label therapies and newly developed vaccines may bring the patients more adverse drug event (ADE) risks. Data mining based on spontaneous reporting systems (SRSs) is a promising and efficient way to detect potential ADEs to help health professionals and patients get rid of the risk.Objective: This pharmacovigilance study aimed to investigate the ADEs of some attractive drugs (i.e., “hot drugs” in this study) in COVID-19 prevention and treatment based on the data from the US Food and Drug Administration (FDA) adverse event reporting system (FAERS).Methods: The FAERS ADE reports associated with COVID-19 from the 2nd quarter of 2020 to the 2nd quarter of 2022 were retrieved with hot drugs and frequent ADEs were recognized. A combination of support, lower bound of 95% confidence interval (CI) of the proportional reporting ratio (PRR) was applied to detect significant hot drug and ADE signals by the Python programming language on the Jupyter notebook.Results: A total of 66,879 COVID-19 associated cases were retrieved with 22 hot drugs and 1,109 frequent ADEs on the “preferred term” (PT) level. The algorithm finally produced 992 significant ADE signals on the PT level among which unexpected signals such as “hypofibrinogenemia” of tocilizumab and “disease recurrence” of nirmatrelvir\ritonavir stood out. A picture of signals on the “system organ class” (SOC) level was also provided for a comprehensive understanding of these ADEs.Conclusion: Data mining is a promising and efficient way to assist pharmacovigilance work, and the result of this study could help timely recognize ADEs in the prevention and treatment of COVID-19.