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

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

アブストラクト	The US FDA has given emergency use authorization to multiple Covid-19 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.
ジャーナル名	Studies in health technology and informatics
Pubmed追加日	2024/1/25
投稿者	Kim, Hyo Jung; Yoon, Jeong-Hwa; Lee, Kyehwa
組織名	Department of Digital Health, Samsung Advanced Institute for Health Science and;Technology, Sungkyunkwan University, Seoul, Korea.;Center of Research Resource Standardization, Research Institution for Future;Medicine, Samsung Medical Center, Seoul, Korea.;Institute of Health Policy and Management, Medical Research Center, Seoul;National University, Seoul, Korea.;Department of Information Medicine, Asan Medical Center, Seoul, Korea.
Pubmed リンク	https://www.ncbi.nlm.nih.gov/pubmed/38269708/