1. Informing selection of drugs for COVID-19 treatment through adverse events analysis
- Author
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Tucker A. Patterson, Huixiao Hong, Wenjing Guo, Takashi E. Komatsu, Yanhui Lu, Bohu Pan, Gokhan Yavas, Weida Tong, Madhu Lal-Nag, Sugunadevi Sakkiah, and Zuowei Ji
- Subjects
0301 basic medicine ,Drug ,medicine.medical_specialty ,2019-20 coronavirus outbreak ,Databases, Factual ,Coronavirus disease 2019 (COVID-19) ,media_common.quotation_subject ,Science ,MEDLINE ,Article ,Databases ,03 medical and health sciences ,0302 clinical medicine ,Pandemic ,Product Surveillance, Postmarketing ,Adverse Drug Reaction Reporting Systems ,Humans ,Medicine ,Drug safety ,Intensive care medicine ,Adverse effect ,Data mining ,media_common ,Clinical Trials as Topic ,Multidisciplinary ,business.industry ,COVID-19 Drug Treatment ,Data processing ,Clinical trial ,030104 developmental biology ,Investigational Drugs ,Safety ,business ,030217 neurology & neurosurgery - Abstract
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.
- Published
- 2021