Safety Profile of Paxlovid in the Treatment of COVID-19
- Авторы: Lv B.1, Gao X.2, Zeng G.2, Guo H.2, Li F.2
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Учреждения:
- Department of Emergency, The First Hospital of Jilin University
- Department of Urology, The First Hospital of Jilin University
- Выпуск: Том 30, № 9 (2024)
- Страницы: 666-675
- Раздел: Immunology, Inflammation & Allergy
- URL: https://vestnikugrasu.org/1381-6128/article/view/646018
- DOI: https://doi.org/10.2174/0113816128280987240214103432
- ID: 646018
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Аннотация
Background:With the urgent and widespread application of Paxlovid, a novel antiviral drug for Coronavirus Disease 2019 (COVID-19) in clinical practice, concerns regarding its actual efficacy and safety have emerged. In order to provide more evidence to support its clinical application, we sought to perform a descriptive analysis of cases who experienced at least one Paxlovid-related adverse event (AEs) and reported to the FDA Adverse Event Reporting System (FAERS) in the post-marketing period.
Methods:Individual adverse event reports between January 1, 2022 and September 30, 2022, were downloaded from the FAERS website. We completed a descriptive study about the safety of Paxlovid in the treatment of COVID-19. Further, we also analyzed the onset time of Paxlovid-related AEs.
Results:As of 30 September 2022, 16,529 de-duplicated cases were submitted to the FDA, and 5,860 (35.45%) were female. The average age was 58.38 years (S.D. 15.50). Most reports (12,390, 74.96%) were submitted by consumers and 1,436 (8.68%) concerned serious outcomes. The most frequently reported AEs were disease recurrence (7,724, 16.23%), dysgeusia (2,877, 6.05%), and diarrhoea (1,448, 3.04%). The median onset time of Paxlovid-related AEs was 8 days (interquartile range,1-10 days), and most of the cases (2,629, 19.12%) occurred on the day after Paxlovid initiation.
Conclusion:This study indicates that the most common AEs reported with Paxlovid in post-marketing experience are consistent with the safety assessment of antiviral drugs. Even without emerging apparent safety concerns, the incidence of serious outcomes was unexpectedly high, and a few cases of potential new AEs occurred.
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Об авторах
Bing Lv
Department of Emergency, The First Hospital of Jilin University
Email: info@benthamscience.net
Xin Gao
Department of Urology, The First Hospital of Jilin University
Email: info@benthamscience.net
Guoqiang Zeng
Department of Urology, The First Hospital of Jilin University
Email: info@benthamscience.net
Hui Guo
Department of Urology, The First Hospital of Jilin University
Email: info@benthamscience.net
Faping Li
Department of Urology, The First Hospital of Jilin University
Автор, ответственный за переписку.
Email: info@benthamscience.net
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