Is the Fast Track Safe? A Safety Evaluation of the COVID-19 Drugs with Real-World Data

被引：0

作者：

Kim, Hyo Jung ^{[1
,2
]}

Yoon, Jeong-Hwa ^{[3
]}

Lee, Kyehwa ^{[4
]}

机构：

[1] Sungkyunkwan Univ, Samsung Adv Inst Hlth Sci & Technol, Dept Digital Hlth, Seoul, South Korea

[2] Samsung Med Ctr, Res Inst Future Med, Ctr Res Resource Standardizat, Seoul, South Korea

[3] Seoul Natl Univ, Inst Hlth Policy & Management, Med Res Ctr, Seoul, South Korea

[4] Asan Med Ctr, Dept Med Informat, Seoul, South Korea

来源：

MEDINFO 2023 - THE FUTURE IS ACCESSIBLE | 2024年 / 310卷

基金：

新加坡国家研究基金会;

关键词：

COVID-19; adverse drug reaction; post-market surveillance; FDA adverse event reporting system;

D O I：

10.3233/SHTI231256

中图分类号：

TP18 [人工智能理论];

学科分类号：

081104 ; 0812 ; 0835 ; 1405 ;

摘要：

The US FDA has given emergency use authorization to multiple Covid19 drugs. We conducted disproportionality analysis to detect adverse reaction rates (ADRs) in the US FDA's Adverse Event Reporting System. We discovered not only severe ADRs but also unique ADRs and effectiveness that might be explained by pharmacokinetics. This shows that real-time safety reviews could be effective methods for comparing the safety and efficacy of fast-track authorized drugs.

引用

页码：1484 / 1485

页数：2