Coronavirus disease 2019 (COVID-19) is an ongoing pandemic and there is an urgent need for safe and effective drugs for COVID-19 treatment. Since developing a new drug is time consuming, many approved or investigational drugs have been repurposed for COVID-19 treatment in clinical trials. Therefore, selection of safe drugs for COVID-19 patients is vital for combating this pandemic. Our goal was to evaluate the safety concerns of drugs by analyzing adverse events reported in post-market surveillance. We collected 296 drugs that have been evaluated in clinical trials for COVID-19 and identified 28,597,464 associated adverse events at the system organ classes (SOCs) level in the FDA adverse events report systems (FAERS). We calculated Z-scores of SOCs that statistically quantify the relative frequency of adverse events of drugs in FAERS to quantitatively measure safety concerns for the drugs. Analyzing the Z-scores revealed that these drugs are associated with different significantly frequent adverse events. Our results suggest that this safety concern metric may serve as a tool to inform selection of drugs with favorable safety profiles for COVID-19 patients in clinical practices. Caution is advised when administering drugs with high Z-scores to patients who are vulnerable to associated adverse events.
【저자키워드】 Data mining, databases, Drug safety, Data processing, 【초록키워드】 COVID-19, Treatment, coronavirus disease, Coronavirus disease 2019, clinical trial, pandemic, drugs, clinical trials, drug, FDA, COVID-19 treatment, adverse events, Surveillance, adverse event, Patient, safety profile, Frequency, COVID-19 patient, Safe, relative frequency, caution, organ, Z-score, Z-scores, combating, collected, evaluate, significantly, reported, evaluated, approved, calculated, statistically, effective drug, 【제목키워드】 COVID-19, Treatment, drug, adverse event, Analysis, Informing,