2024 Spring International Convention of
The Pharmaceutical Society of Korea

2024 Spring
International Convention of PSK

04.17(WED) - 04.19(FRI)
D+28

Abstracts

P12-3

Safety monitoring of oral antiviral COVID-19 treatment using korea adverse event reporting system (KAERS) database

 

  • Yunju Choe1, Se Jung Park1, Ju Hwan Kim2, Dongwon Yoon1,2, Dong Yoon Kang3, Jae Hoon Jung4, Ju-Young Shin*1,2,5
  • 1Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, South Korea
  • 2School of Pharmacy, Sungkyunkwan University, Suwon, South Korea
  • 3Department of Preventive Medicine, Ulsan University Hospital, University of Ulsan College of Medicine. Ulsan. Korea
  • 4Department of Preventive Medicine. Gachon University College of Medicine. Incheon. South Korea
  • 5Department of Clinical Research Design & Evaluation, Samsung Advanced Institute for Health Sciences & Technology, Sungkyunkwan University, Seoul, South Korea

Nirmatrelvir/ritonavir(NMV/r) and Molnupiravir(MOL), oral antivirals for COVID-19, are highly effective treatment for symptom relief and reducing mortality risk in patients with mild to moderate COVID-19. However, real-world safety data are still limited. This study aimed to evaluate the association between NMV/r, MOL and adverse events(AEs), and identify safety signals not previously known. To identify major adverse events and safety signals associated with NMV/r and MOL, we conducted pharmacovigilance study using drug-related AEs reported to KIDS KAERS DB(2305A0011). Disproportionality analysis were performed using reporting odds ratio (ROR) and information component (IC) method to detected new safety signals not listed in drug label. In this study, AEs reported following the use of NMV/r and MOL were generally not serious and resembled results of previous studies. However, with NMV/r, new safety signals such as olfactory nerve disorders, urinary AEs, appetite disorders, and hallucinations were detected. Also, some cardiovascular AEs were identified after MOL usage, which were not listed on drug label. We expected this study to provide basic data of safety for oral antivirals of COVID-19 available in Korea and may contribute to the development of future drug safety guidelines.



Q&A

작성하기
  • There are no registered questions
TODAY 2024. 05. 17

2024 Spring Convention

D+28

Conference infomation

Conference Schedule
Apr. 17(Wed) ~ 19(Fri), 2024
Conference Venue
BPEX (Busan Port International Exhibition & Convention Center) Busan Metropolitan City, Republic of Korea
Location
Early Registration Period
Feb. 20(Tue) ~ Apr. 3(Wed), 2024
Abstract Submission Period
Feb. 20(Tue) ~ Apr. 3(Wed), 2024
Certificate of Attendance