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.

Post‐marketing safety concerns with nirmatrelvir: A disproportionality analysis of spontaneous reports submitted to the FDA Adverse Event Reporting System

“…Disease recurrence, dysgeusia, diarrhoea, nausea, headache and vomiting were the common and significance AEs of nirmatrelvir plus ritonavir. The safety signals coincide with those in previous clinical trails 7,10 and pharmacovigilance analysis 11,12 . Notably, the highest safety signal was disease recurrence.…”

“…These findings were consistent with the clinical trial of nirmatrelvir 7 and pharmacovigilance reports. 11,12 The majority of these events were resolved and were mild or moderate. 7 However, these events were similar to COVID-19 symptoms.…”

“…The safety signals coincide with those in previous clinical trails 7,10 and pharmacovigilance analysis. 11,12 Notably, the highest safety signal was disease recurrence. Several studies reported this 'rebound' effect.…”

“…9 To the best of our knowledge, nirmatrelvir safety profiles were based on clinical trials 7,10 and two post-market analyses before July 2022. 11,12 As a novel antiviral drug, the potential safety risks have not yet been fully studied. Given the rapidly increasing number of safety reports related to nirmatrelvir during 2022, ongoing epidemiologic surveillance and post-marketing analysis should be prioritized in order to mitigate any potential safety concerns.…”

BNT162b2 COVID-19 Vaccine Safety among Healthcare Workers of a Tertiary Hospital in Italy

“…Furthermore, based on the information gathered from our study, it might be useful to dynamically identify profiles, or “phenotypes”, of disease from individual report to facilitate the subsequent reporting of adverse events. This might facilitate signal identification, allowing for effective identification and response to safety concerns, as well as informing the development of effective policies and strategies [ 61 , 62 , 63 ]. Together with a follow-up system, the tailored adaptation of the reporting system to individual reports submitted by patients might allow pharmacovigilance and prevention institutions to identify and respond to any health concerns that may arise more promptly.…”